GLP-1 Patent Expiration Dates: U.S. Patent and Exclusivity Database (2026)

The RX Index Research · Independent research and reference resource for primary-sourced prescription-medication data

By The RX Index Editorial Team Last verified: August 3, 2026 · FDA records accessed through the July 2026 Orange Book edition · Dataset version 1.0

There is no single U.S. GLP-1 patent expiration date. FDA-listed drug-substance and drug-product patents include December 5, 2031 for a semaglutide patent shared across the current products analyzed here and May 13, 2036 for a tirzepatide patent shared by Mounjaro and Zepbound, but later product- and use-specific patents produce listed dates as far out as February 17, 2041 for selected Ozempic and injectable Wegovy records, December 30, 2041 for Mounjaro, and July 22, 2039 for Zepbound. These are listed patent dates, not generic-launch forecasts.

The most quotable findings: Across the current U.S. semaglutide records in this dataset, the latest listed patent date spans 2,483 days, or 6.80 years—from May 2, 2034 for Rybelsus to February 17, 2041 for selected injectable Ozempic and Wegovy records. Inside Ozempic alone, two current FDA product-number records differ by 2,798 days, or 7.66 years, at their latest non-delisted drug-substance-or-drug-product endpoint. Mounjaro and Zepbound share a May 13, 2036 listed tirzepatide date but differ by 892 days, or 2.44 years, at their latest listed endpoint of any category.

Listed patent dates—not generic-launch forecasts. Table 1 uses selected current FDA product-number records that carry materially different patent lists. It does not imply that one row represents every strength sold under the brand.

Source: The RX Index Research analysis of linked FDA Orange Book patent and exclusivity records and FDA's Paragraph IV Patent Certifications list dated July 15, 2026. “Common listed DS/DP date” means the date on a sponsor-submitted drug-substance/drug-product row shared by the selected records—U.S. patent 8,129,343 for semaglutide and U.S. patent 9,474,780 for tirzepatide. It does not mean that no later DS/DP patent exists. Last verified August 3, 2026.

Source: The RX Index Research analysis of linked FDA Orange Book records; the June 2026 Orange Book cumulative supplement for Foundayo; the FDA Purple Book; FDA's 2024 and 2025 first-generic lists; FDA's exenatide pharmacovigilance review; and Eli Lilly SEC filings. Last verified August 3, 2026.

What are the current U.S. GLP-1 patent expiration dates?

U.S. GLP-1 patent expiration dates vary by ingredient, brand, FDA application, product number and patent category. A semaglutide DS/DP row shared across the current products analyzed here runs to December 5, 2031, and the shared tirzepatide DS/DP row for Mounjaro and Zepbound runs to May 13, 2036, but later product- and use-specific listings extend to 2041.

The tables above are the answer in full. Three things about them are worth stating plainly before you use them.

First, we report three separate endpoints rather than one, because the source records contain three materially different things:

• The common listed drug-substance/drug-product date. This is a shared sponsor-submitted DS/DP row that makes a useful cross-product reference point. It is not labeled “the one controlling patent,” and FDA warns that Orange Book flags do not establish the full range of claims that may be asserted.
• The latest non-delisted listed drug-substance or drug-product date. This is the last current row for that product number carrying a DS or DP flag.
• The latest non-delisted listed date of any category. This adds use-only patents, which may cover a specific approved indication or use rather than every possible version of the drug.

Second, a presentation is not the same as a brand. FDA assigns a product number to each application product, and its downloadable-data documentation says each strength is a separate product. Different product numbers under the same brand can carry different patent lists. Ozempic is not one row. It is several, and their current patent records do not all produce the same endpoint.

Third, and most important: these dates describe what appeared in FDA records on the verification date. They do not tell you when a lower-cost version will be approved, commercially marketed or available at a pharmacy.

Why do the common semaglutide and tirzepatide dates land 14 years after approval?

35 U.S.C. § 156(c)(3) limits an extended patent so that the remaining patent term plus the extension does not exceed fourteen years after approval. The current FDA-listed dates for semaglutide patent 8,129,343 and tirzepatide patent 9,474,780 each land on that fourteen-year anniversary—but the public records do not support treating the two patent histories as identical.

The arithmetic is exact:

Source: Ozempic approval letter; Mounjaro approval package; 35 U.S.C. § 156; USPTO's patent-term-extension application and certificate lists; and FDA's Mounjaro regulatory-review-period determination. Last verified August 3, 2026.

Here is what the records establish.

Ozempic has an issued extension record. USPTO's current certificate spreadsheet lists patent 8,129,343 with a pre-extension expiration date of January 29, 2029 and an extension of 1,040 days. That calculation reaches December 5, 2031, exactly fourteen years after FDA approved Ozempic.

Mounjaro has an extension application and a current FDA-listed date, but the public certificate list was not final as of the last check. FDA's Federal Register determination says the regulatory review period was 2,208 days and that Lilly sought 129 days of patent term extension. FDA currently lists May 13, 2036 for patent 9,474,780. USPTO's application spreadsheet updated through May 8, 2026 includes the Mounjaro application, while the issued-certificate spreadsheet with the same update date does not list that patent. The correct statement is that the FDA-listed date reaches the statutory ceiling and a 129-day extension was requested—not that an issued certificate was already shown in USPTO's public list.

The March 20, 2026 semaglutide date is a different U.S. patent. The current Ozempic product 004 record separately lists patent 8,536,122 as a DS/DP patent expiring March 20, 2026 and patent 8,129,343 as a DS/DP patent expiring December 5, 2031. Both dates can be quoted accurately, but they refer to different patent rows. The extension on 8,129,343 did not turn the March 2026 date on 8,536,122 into December 2031; USPTO's certificate data show that the extended patent's own pre-extension date was January 29, 2029.

What this means practically. The fourteen-year ceiling explains why the two current FDA-listed dates line up exactly with their products' approval anniversaries. It does not establish the status, validity or scope of later formulation, device, product or method-of-use patents, and it does not establish a generic entry date.

What does this GLP-1 patent table show, and what does it not show?

It shows the patent and exclusivity information appearing in specified official records on a specified verification date, preserved at the FDA product-number level. It does not establish patent validity, claim scope, infringement, litigation outcomes, FDA approval timing, commercial launch or pharmacy availability.

The distinction matters enough to spell out, because it is where one-date summaries break.

Orange Book patent dates and flags are submitted by the application holder. FDA's data documentation defines the patent-expiration field as the date submitted by the application holder, including applicable extensions. The DS and DP fields identify how the sponsor submitted the patent information.

FDA warns against treating the listing as a complete claim map. The agency states on its patent pages that Orange Book users should not rely on a listing to determine the range of claims an NDA holder or patent owner may assert.

Patents and regulatory exclusivity are separate systems. A patent is issued through the U.S. patent system. FDA exclusivity is recorded against an approved product and can affect approval timing for a competing application. They have separate fields and separate dates, which is why this page does not merge them into one “protected until” column.

A Paragraph IV submission is another separate event. FDA's list describes drug products for which one or more substantially complete ANDAs containing a Paragraph IV certification have been submitted. A certification is a patent challenge inside a generic application. It is not an approval and not commercial marketing.

A blank cell is not a finding. Where a table says no exclusivity row or no current patent row was shown, it reports what appeared in the specific record checked. It does not prove that no other patent, application, proceeding or legal right exists.

How was this GLP-1 patent expiration dataset produced?

We matched FDA applications to selected product numbers, then to their patent, exclusivity and Paragraph IV records, and preserved the sponsor-submitted DS, DP, use-code and delist fields rather than collapsing everything into one brand-level year. Every displayed endpoint links to the official record or edition used to calculate it.

Here is the whole method, so anyone can check or rebuild it.

Scope

Version 1.0 covers selected current U.S. product-number records for semaglutide—Ozempic, Rybelsus, injectable Wegovy, Wegovy HD, Wegovy FlexTouch, oral Wegovy and oral Ozempic—and tirzepatide—Mounjaro and Zepbound. It adds current or legacy comparator records for liraglutide, orforglipron calcium, dulaglutide and exenatide.

The selected rows are the records needed to show the materially different patent endpoints documented on this page. This edition does not claim that Table 1 reproduces every strength or product number under every brand. It excludes fixed-dose insulin combinations and discontinued historical products that were not separately audited. Trulicity is handled separately because FDA lists it under a BLA in the Purple Book rather than as an Orange Book NDA product.

Source hierarchy

Sources were used in this order:

1. FDA Orange Book electronic patent and exclusivity records.
2. FDA Orange Book downloadable data files and cumulative supplements.
3. FDA Paragraph IV Patent Certifications list.
4. USPTO patent-term-extension application and certificate lists.
5. FDA approval letters and Federal Register patent-term-extension determinations.
6. FDA Purple Book for licensed biologics.
7. FDA first-generic approval lists and other FDA records.
8. Issuer SEC filings where the official FDA register does not provide an Orange Book-comparable patent table.

Where only a company estimate is available, the page labels it as a company estimate and gives no false-precision date.

How the three endpoints are calculated

• Common listed DS/DP date: the date attached to a sponsor-submitted DS/DP patent row shared by the selected records. It is a comparison field, not a legal conclusion that the row is the sole or controlling patent.
• Latest non-delisted listed DS/DP date: the latest patent date carrying a DS or DP flag for that product number after rows marked “Delist Requested” are excluded.
• Latest non-delisted listed date, any category: the latest non-delisted patent date for that product number, including use-only rows.

How delist-requested patents are treated

Patents with FDA's “Delist Requested” flag are retained as part of the source record but excluded from the headline endpoints. FDA explains that a patent can remain visible after a sponsor requests delisting because a first applicant may retain potential eligibility for 180-day exclusivity based on a Paragraph IV certification to that patent for a period of time.

How pediatric extensions are treated

Where an FDA record includes a six-month pediatric extension row, the extended date is preserved and labeled. This is why Victoza and Saxenda show February 13, 2026 and July 9, 2037 endpoints, and why Bydureon BCise's latest DS/DP endpoint is April 4, 2031 rather than April 4, 2026.

How Paragraph IV counts are handled

FDA's column is named “Number of Potential First Applicant ANDAs Submitted.” It counts substantially complete ANDAs containing at least one Paragraph IV certification on the first submission date for the listed strength group. Strength groups can overlap. The counts in the tirzepatide table below must not be added together and described as a unique number of applicants or applications.

How original date differences are calculated

Calendar-day differences were divided by 365.2425 for approximate years. Each calculation was recomputed from the displayed source dates:

• Semaglutide latest-date spread: February 17, 2041 minus May 2, 2034 = 2,483 days / 6.80 years.
• Ozempic selected-record DS/DP spread: February 17, 2041 minus June 21, 2033 = 2,798 days / 7.66 years.
• Mounjaro–Zepbound latest-any spread: December 30, 2041 minus July 22, 2039 = 892 days / 2.44 years.

These are descriptive differences between listed dates. They are not measures of patent strength, enforceability, commercial exclusivity or expected market entry.

Verification rule

Two checks are required before a row is published:

1. The application and product identity must match the linked source record.
2. Every displayed endpoint and derived figure must be reproducible from the records and rules stated above.

Anything failing either check is withheld rather than estimated.

What we did not do

We did not interpret patent claims, review complete prosecution histories, determine infringement, assess validity, predict litigation outcomes or perform a freedom-to-operate analysis. This dataset is not a substitute for the underlying patents, court records or advice from qualified patent counsel.

Why is there no single GLP-1 patent expiration date?

Because one ingredient can be sold under several brands, applications and FDA product numbers, and each record can contain drug-substance, drug-product and method-of-use patents on different schedules—with FDA exclusivity and patent challenges layered on top as separate systems.

The chain runs like this:

Ingredient → brand → FDA application → product number → individual patent rows → FDA exclusivity → Paragraph IV and approval status.

Semaglutide is the clearest illustration. The selected current records on this page include four NDAs and seven named presentation types represented by eight product-number records. They share a December 5, 2031 DS/DP row, but their latest listed endpoints range from May 2, 2034 to February 17, 2041.

The source categories also mean different things:

• Drug-substance flags identify patents the sponsor submitted as claiming the drug substance.
• Drug-product flags identify patents the sponsor submitted as claiming the drug product.
• Use codes identify a patent submitted as covering an approved indication or use.
• Exclusivity codes record FDA-granted exclusivity and its expiration date.
• Paragraph IV records show substantially complete generic applications that contained patent challenges for the listed drug and strength group.

FDA's warning still controls the interpretation: these flags are useful fields, not a complete adjudication of patent scope.

When do semaglutide patents expire for Ozempic, Wegovy and Rybelsus?

The selected current U.S. semaglutide records share a December 5, 2031 DS/DP patent date. Their later endpoints differ substantially: Rybelsus reaches May 2, 2034 in this comparison, oral Ozempic and oral Wegovy reach February 1, 2039, and selected injectable Ozempic and Wegovy records reach February 17, 2041.

Ozempic. Product 004's latest non-delisted DS/DP date is June 21, 2033; its latest listed date of any category is October 10, 2038, and that final row is use-only. Product 005 lists a DP patent through February 17, 2041. Several older patent rows in product 004 carry FDA delist-request flags.

Wegovy. The selected injectable records diverge. Standard injectable Wegovy product 001 and Wegovy HD product 006 both reach February 17, 2041 on a DP patent. Wegovy FlexTouch product 012 stops at December 5, 2031 on its current DS/DP rows and carries a use-only patent to May 13, 2040. That is a 3,082-day, or 8.44-year, method-only tail between its latest DS/DP date and its latest date of any category.

Rybelsus. Product 001's current record includes a DS/DP patent through May 2, 2034. That is the earliest latest-any endpoint among the selected current semaglutide records.

Oral Ozempic and oral Wegovy. The selected records for both products carry a latest DP date of February 1, 2039.

The spread. Across the current U.S. semaglutide records in this dataset, the latest listed patent date ranges from May 2, 2034 to February 17, 2041—2,483 days, or 6.80 years. Same ingredient. Same country. Different products and patent records.

Source: The linked FDA records for N209637, N213051, N215256 and N218316. Last verified August 3, 2026.

Why do current Ozempic product records have different listed patent dates?

Because FDA product numbers identify separate application products, and their patent rows are maintained separately. In the records examined here, Ozempic product 004's latest non-delisted DS/DP date is June 21, 2033 while product 005 lists a DP patent through February 17, 2041—a difference of 2,798 days, or 7.66 years, inside a single brand.

Source: The RX Index Research calculation from linked FDA Orange Book records for NDA 209637. Last verified August 3, 2026.

Be careful how you read this. It is a difference between two FDA product-number records as currently listed. It is not an adjudicated extension across every Ozempic product, and it is not a statement that competition is legally impossible until 2041. It means that “the Ozempic patent expires in [year]” is incomplete unless the writer identifies the product record and the kind of patent being described.

When do tirzepatide patents expire for Mounjaro and Zepbound?

Mounjaro and Zepbound both list patent 9,474,780 as a DS/DP patent through May 13, 2036. Both selected records then reach June 14, 2039 on a later DS/DP or DP patent, but their final use-only endpoints differ: December 30, 2041 for Mounjaro and July 22, 2039 for Zepbound—a difference of 892 days, or 2.44 years.

The shared date is not the end of either current record. Mounjaro product 007 lists patent 11,357,820 as DS/DP through June 14, 2039 and patent 12,453,756 as DP through the same date. Its latest row is use-only patent 12,295,987 through December 30, 2041.

Zepbound product 007 lists patent 11,357,820 as DP through June 14, 2039. Its latest row is a use-only patent through July 22, 2039.

The gap between the latest DS/DP date and the latest date of any category shows how much of the final listed tail rests on use-only rows:

Source: The RX Index Research calculation from the FDA product records linked in Tables 1 and 2. Method-only listed tail = latest non-delisted listed date of any category minus latest non-delisted listed DS/DP date where the final row is use-only. Last verified August 3, 2026.

Victoza's 11.40-year tail is the one to notice. FDA approved a first generic referencing Victoza in December 2024 even though its current Orange Book record includes a use patent with pediatric extension to July 2037. That coexistence is direct evidence that a latest use-patent date cannot be treated as a universal generic-launch date.

What do the GLP-1 Paragraph IV patent-challenge records show?

FDA's July 15, 2026 list shows semaglutide Paragraph IV submissions beginning in December 2021 and tirzepatide submissions dated May 13, 2026. The list records substantially complete ANDAs containing patent challenges; it does not say that those applications are approved or commercially marketed.

A Paragraph IV certification states that a listed patent is invalid, unenforceable or will not be infringed by the proposed generic product. FDA explains that if the sponsor or patent holder sues within 45 days after notice, approval is generally postponed for 30 months unless the patent expires or a court decision ends the stay earlier. A potential first applicant may qualify for 180-day exclusivity, but FDA does not decide that status merely because the application appears on the list.

Source: FDA, Paragraph IV Patent Certifications, July 15, 2026. FDA's counts apply to the strength group in each row. They are not a total number of unique applicants across the ingredient.

The semaglutide record corrects a common impression that patent challenges are only a future event. FDA's table shows a grouped Ozempic first-submission date in 2021 and a grouped injectable Wegovy first-submission date in 2022.

Source: FDA, Paragraph IV Patent Certifications, July 15, 2026. Every row above shows May 13, 2026 as the first-submission date. Strength groups overlap, so the counts must not be summed into a unique total.

May 13, 2026 is exactly four years after FDA approved Mounjaro. FDA's Orange Book lists NCE exclusivity for Mounjaro and Zepbound through May 13, 2027. Those dates are facts in separate FDA records; this page does not infer an approval or launch date from them.

As of FDA's July 15, 2026 list, the first-applicant approval and first-commercial-marketing fields for these semaglutide and tirzepatide rows were blank. FDA explains that a blank status field means it had not posted the corresponding determination in that list. The Paragraph IV list is not a substitute for a complete Drugs@FDA approval search.

Why do some sources say semaglutide patents expired in 2026?

Because FDA currently lists two separate semaglutide DS/DP patent rows with different dates: U.S. patent 8,536,122 expired March 20, 2026, while U.S. patent 8,129,343 is listed through December 5, 2031. A source can quote either date accurately and still mislead readers if it does not identify the patent and jurisdiction.

The clearest official example is the Ozempic product 004 record:

Source: FDA Orange Book, Ozempic N209637 product 004. Last verified August 3, 2026.

USPTO's issued-certificate data identify the December 2031 patent's own pre-extension expiration as January 29, 2029 and the extension as 1,040 days. That is why the safe explanation is not “the March 2026 patent was extended to 2031.” The records show two separate patents and a separate extension history.

Non-U.S. patent status is jurisdiction-specific. A date from another country's patent register does not establish U.S. status, and this U.S. dataset does not publish a country-by-country expiration table that has not been separately audited.

Which GLP-1 drugs have FDA-approved generics in the United States?

FDA has approved first generics referencing Byetta, Victoza and Saxenda. Those are approval events, not proof that each product was commercially available at every pharmacy on the approval date; FDA expressly says approved drugs are not always available on or immediately after the listed date.

Source: FDA's 2024 First Generic Drug Approvals and 2025 First Generic Drug Approvals. FDA's first-generics overview states that approved drugs are not always available on or after the listed approval date.

The Victoza case is the cleanest reality check. FDA approved a first generic referencing Victoza on December 23, 2024. Victoza's current Orange Book record still lists a use patent with pediatric extension to July 9, 2037. Both statements are true at once. The records do not establish from this fact alone which legal mechanism permitted approval, but they do establish that “latest listed patent date” and “first generic approval date” are not interchangeable.

The exenatide records add a separate market-status complication. FDA says the Byetta and Bydureon BCise applicants notified the agency on August 16, 2024 of plans to permanently discontinue marketing. That status belongs beside the patent dates because a discontinued reference brand and an approved generic present a different market picture from an actively promoted blockbuster.

Why is Trulicity handled differently from the other GLP-1 drugs?

FDA lists Trulicity as a 351(a) biologic under BLA 125469 in the Purple Book, not as an NDA drug with an Orange Book patent table. Its patent information is therefore not directly comparable to the product-number records in Table 1.

The regulatory-pathway distinction is visible in the official registers:

• Semaglutide, tirzepatide, liraglutide and exenatide products in this dataset appear under NDAs and Orange Book records.
• Trulicity appears in FDA's Purple Book as a 351(a) BLA product.

Lilly's 2022 Form 10-K said Trulicity was protected in the United States by a compound patent through 2027 and biologics data protection through 2027. Lilly's 2025 Form 10-K no longer gives the same compact table; it says Trulicity will lose significant patent and remaining data protections “in the next few years.” The page therefore reports 2027 only as Lilly's earlier company estimate, not as an FDA Orange Book date.

This also answers a recurring terminology question. The semaglutide products in this dataset are FDA-approved under NDAs and are the subject of ANDA Paragraph IV records. Trulicity is the product here that FDA identifies under the biologic pathway.

Source: FDA Purple Book; Eli Lilly 2022 Form 10-K and 2025 Form 10-K.

What happened to the GLP-1 patent listings the Federal Trade Commission challenged?

On April 30, 2024, the FTC sent Novo Nordisk a letter disputing 36 Orange Book listing instances tied to these products: 17 for Ozempic, 17 for Saxenda and 2 for Victoza. The letter stated the FTC's position that the listed device patents did not meet Orange Book listing requirements; it was a regulatory challenge, not a final court judgment on patent validity.

The count matters because the draft version of this page compressed the letter to 17 total listings. The official attachment identifies 17 Ozempic patents, 17 Saxenda patents and 2 Victoza patents.

An Orange Book listing has procedural consequences. FDA explains that a timely patent suit after Paragraph IV notice can generally postpone approval for 30 months. The FTC's broader policy position is that improper listings can delay competition.

The current Ozempic product 004 record now marks multiple DP patent rows “Delist Requested.” FDA's data documentation explains that a row can remain visible after a sponsor requests delisting because a first applicant may retain potential 180-day-exclusivity eligibility based on a certification to that patent for a period of time.

That is why delist status is part of this dataset rather than a footnote. The set of visible patent rows can change without a patent reaching its expiration date, and a trustworthy version history needs to record those changes rather than silently replacing them.

Source: FTC, April 30, 2024 letter to Novo Nordisk concerning Ozempic, Saxenda and Victoza listings; FDA Orange Book Data Files; and the linked current Ozempic product 004 record.

Does patent expiration mean a generic GLP-1 launches immediately?

No. A listed patent date, FDA exclusivity, ANDA approval and commercial availability are four separate events. The official records on this page provide examples of why none should be used as a substitute for the others.

A useful way to hold the sequence is:

1. Patent listing and expiration: what patent information the NDA holder submitted and the expiration date currently displayed by FDA.
2. FDA exclusivity: what exclusivity FDA recorded against the approved product and when it expires.
3. ANDA submission and approval: whether a generic application has been filed, challenged patents through Paragraph IV, and received tentative or final approval.
4. Commercial marketing and availability: whether the approved product has actually been launched and is available through the market.

The records show the clocks moving independently:

• FDA approved a first generic referencing Victoza in December 2024 while a use patent with pediatric extension remained listed to July 2037.
• FDA's Paragraph IV table has separate columns for first-applicant approval and first commercial marketing because those dates can differ.
• FDA warns that a first-generic approval date does not guarantee immediate product availability.
• Byetta and Bydureon BCise had planned brand discontinuations documented separately from their patent records.

This dataset reports patent, exclusivity and Paragraph IV information and identifies FDA first-generic approvals where verified. It does not predict a commercial launch date for semaglutide or tirzepatide.

Why do GLP-1 patent expiration dates matter in 2026?

Because the U.S. record changed in several material ways at once: one semaglutide DS/DP patent reached its March 20, 2026 date, new current product records carried later patent lists, oral Wegovy appeared in FDA's Paragraph IV table, tirzepatide's first Paragraph IV date appeared as May 13, 2026, and Foundayo entered the June 2026 Orange Book supplement.

Any one of those events can make a one-line summary stale.

The current Ozempic product 005 record lists a DP patent to February 17, 2041. The current Mounjaro record lists a use-only patent to December 30, 2041. FDA's Paragraph IV list now shows that semaglutide patent challenges began years earlier than the tirzepatide challenge date. And the same Ozempic product 004 record contains both the March 20, 2026 semaglutide DS/DP date and the December 5, 2031 DS/DP date.

That is the practical reason this page reports exact applications, product numbers, categories, challenge dates and verification dates instead of one “patent cliff” year.

What are the limitations of this dataset?

This is a dated reference dataset, not a legal opinion and not a market forecast. We would rather state the boundaries plainly than have a number quoted for something it cannot support.

On the patent data. Orange Book expiration dates are submitted by the application holder and include applicable extensions. The DS and DP flags indicate how information was submitted; they do not establish the complete scope of a patent's claims. FDA states that users should not rely on an Orange Book listing to determine the range of claims an NDA holder or patent owner may assert.

On patents versus exclusivity. These are separate systems with separate dates. Neither one alone determines competitive entry.

On Paragraph IV records. FDA's list reports substantially complete ANDAs containing Paragraph IV certifications and potential first-applicant counts for specific strength groups. It is not a complete list of every generic application, every patent claim challenged, every lawsuit or every approval.

On the latest-date columns. The latest listed patent date is not the earliest possible approval date and is not a guaranteed latest launch date. Victoza demonstrates that a generic approval can coexist with a later listed use patent.

On approval versus availability. FDA approval permits marketing but does not establish that the product was commercially launched or available on the approval date.

On jurisdiction. Tables 1 through 5 are U.S.-specific. A date from another country's register establishes nothing about U.S. status, and the reverse is equally true.

On scope. Version 1.0 covers the selected products and product-number records named in the methodology. It does not claim to cover every GLP-1 product ever approved, every strength, every fixed-dose insulin combination, every unlisted patent, every foreign patent, every pending application or every litigation event.

On Trulicity. The Purple Book does not provide an Orange Book-comparable product-number patent table for Trulicity. The 2027 figure is identified as an Eli Lilly estimate from its 2022 Form 10-K, not an FDA patent-expiration record.

On timing. Orange Book records and FDA's Paragraph IV list change. The version history identifies the edition and verification date used here.

On what we are not. The RX Index Research is not patent counsel, an investment adviser or a clinical service. Nothing here is legal, financial or medical advice. For a legal question, consult qualified patent counsel. For a medication question, consult a prescriber or pharmacist. For the authoritative record, use the official sources linked throughout.

Frequently asked questions about GLP-1 patent expiration dates

Is there one GLP-1 patent expiration date?

No. Dates vary by ingredient, brand, FDA application, product number, patent category, regulatory exclusivity and jurisdiction. Within the selected current semaglutide records alone, latest listed endpoints range from May 2, 2034 to February 17, 2041.

When does the U.S. semaglutide patent expire?

There is more than one U.S. semaglutide patent row. FDA currently lists patent 8,536,122 through March 20, 2026 and patent 8,129,343 through December 5, 2031 as DS/DP patents in the Ozempic product 004 record. Later product- and use-specific patents on selected semaglutide products extend to February 17, 2041.

When does the U.S. tirzepatide patent expire?

Mounjaro and Zepbound both list patent 9,474,780 as a DS/DP patent through May 13, 2036. Their selected current records also include later DS/DP or DP dates through June 14, 2039. Mounjaro's latest listed use-only date is December 30, 2041; Zepbound's is July 22, 2039.

Why do the common semaglutide and tirzepatide dates land 14 years after approval?

35 U.S.C. § 156(c)(3) caps the combined remaining patent term and extension at fourteen years after approval. Ozempic's issued USPTO certificate data confirm a 1,040-day extension from a January 29, 2029 pre-extension date to December 5, 2031. For Mounjaro, FDA lists May 13, 2036 and the Federal Register says Lilly sought 129 days; USPTO's issued-certificate spreadsheet updated through May 8, 2026 did not yet list that patent.

Does Ozempic have a patent running to 2041?

A current Ozempic product 005 record lists a DP patent through February 17, 2041. That statement applies to that FDA product number and that patent row. It does not mean every Ozempic presentation carries the same list or that generic competition is legally impossible until 2041.

Why do some sources say semaglutide expired in 2026?

FDA lists a semaglutide DS/DP patent, 8,536,122, through March 20, 2026. The same Ozempic product record separately lists patent 8,129,343 through December 5, 2031. A source that reports only one date without naming the patent can turn a true date into a misleading answer.

Is semaglutide a biologic that requires a biosimilar?

FDA approved the semaglutide products in this dataset under NDAs and lists them in the Orange Book; FDA's Paragraph IV records concern ANDAs, the generic-drug pathway. Trulicity is listed separately in the Purple Book as a 351(a) biologic under BLA 125469.

Are any generic GLP-1 products FDA-approved in the United States?

Yes. FDA approved first generics referencing Byetta on November 19, 2024, Victoza on December 23, 2024 and Saxenda on August 27, 2025. FDA also warns that approval does not guarantee immediate commercial availability.

Have the Mounjaro or Zepbound patents been challenged?

FDA's July 15, 2026 Paragraph IV list shows first submissions dated May 13, 2026 for multiple Mounjaro and Zepbound strength groups. A Paragraph IV submission is a patent challenge inside a substantially complete ANDA. It is not an approval or launch.

Why can a generic be approved before the latest listed patent date?

The latest listed date may belong to a product- or use-specific patent rather than a patent that blocks every proposed generic label or product. Patent challenges, court decisions, settlements and other legal pathways can also affect approval. This page does not infer which mechanism applied to Victoza; it reports the verified fact that FDA approved a generic in December 2024 while a later use patent remained listed.

When will generic Ozempic, Wegovy, Mounjaro or Zepbound actually be available?

The official records used here do not establish a commercial availability date. Patent listings, exclusivity, Paragraph IV submissions, FDA approval and commercial marketing are separate events. This page does not publish a forecast where the public record does not provide one.

Data availability

Tables 1 through 5 constitute U.S. GLP-1 Patent and Exclusivity Dataset version 1.0. Every displayed endpoint links to the official record or edition used to calculate it, and the methodology above defines each derived field.

No separate public CSV or JSON download is listed in this edition. Dataset structured data therefore does not claim a downloadable distribution that is not visibly available on the page.

How to cite this page

The reference below identifies the page, dataset edition and verification date so this version can be distinguished from later updates.

The RX Index Editorial Team. “GLP-1 Patent Expiration Dates: U.S. Patent and Exclusivity Database (2026).” The RX Index Research, dataset version 1.0. Last verified August 3, 2026. https://therxindex.com/research/glp-1-patent-expiration-dates/

Primary sources

• FDA Orange Book Data Files — field definitions for product numbers, patent dates, DS/DP flags, delist requests and exclusivity dates.
• FDA Orange Book search — current patent and exclusivity records by application and product number.
• FDA Paragraph IV Patent Certifications, July 15, 2026 — first-submission dates, strength-group counts, approval and commercial-marketing fields, and last qualifying patent dates.
• FDA Patent Certifications and Suitability Petitions — definitions and procedure for Paragraph IV certifications, 30-month stays and FDA's table fields.
• 35 U.S.C. § 156 — patent-term-extension statute and fourteen-year limit.
• USPTO patent-term-extension application and certificate lists — official application and issued-certificate spreadsheets updated through May 8, 2026.
• Ozempic approval letter — December 5, 2017 approval.
• Mounjaro approval package — May 13, 2022 approval.
• Federal Register determination for Mounjaro — 2,208-day regulatory review period and 129-day extension request.
• FDA Orange Book cumulative supplement, June 2026 — Foundayo / orforglipron calcium records.
• FDA Purple Book — Trulicity BLA 125469 and 351(a) pathway.
• FDA 2024 First Generic Drug Approvals — Byetta- and Victoza-reference first-generic approvals.
• FDA 2025 First Generic Drug Approvals — Saxenda-reference first-generic approval.
• FDA First Generic Drug Approvals overview — distinction between approval and availability.
• FDA exenatide pediatric pharmacovigilance review — planned discontinuation notices for Byetta and Bydureon BCise.
• FTC April 30, 2024 letter to Novo Nordisk — challenged Ozempic, Saxenda and Victoza listing instances.
• Eli Lilly 2022 Form 10-K and 2025 Form 10-K — company statements concerning Trulicity patent and data protection.

Version history

Version 1.0 — August 3, 2026. First publication. Establishes a selected product-number-level U.S. dataset using FDA Orange Book records accessed through the July 2026 edition, the June 2026 cumulative supplement for Foundayo, USPTO patent-term-extension data updated through May 8, 2026, and FDA's Paragraph IV list dated July 15, 2026. Introduces the three-endpoint reporting structure, the listed-date spread, the method-only listed-tail measure and the strength-group Paragraph IV tables.

Future editions should list each changed row—previous value, new value, source and verification date—rather than replacing figures silently, so a statistic from an earlier edition remains traceable.

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About this resource. The RX Index Research is an independent research and reference resource for primary-sourced prescription-medication data.

Who created this: The RX Index Editorial Team. How it was produced: FDA application, product, patent, exclusivity, generic-approval and challenge records were normalized using the methodology above. Why it exists: To provide a current, reproducible U.S. reference that preserves the distinctions ordinarily lost when patent information is compressed into a single date.

This page is educational and is not legal, financial or medical advice.