From FDA's own records

Is there a generic Ozempic, Wegovy or Zepbound?

No. A generic of Ozempic has only a tentative approval, which means it cannot be sold. Generics on FDA's approved list: 8 of Victoza and 3 of Saxenda. Generic makers are lining up, though: 13 applications challenged Mounjaro's patents on a single day, May 13, 2026.

Read every day from FDA's Orange Book (FDA's file of Oct 9, 2026), Drugs@FDA and the Paragraph IV list (as of Oct 27, 2026). Newest event recorded here: Aug 28, 2026.

Brand by brand

Which brands have a generic, and what stands in the way

Patents and exclusivity already run out are left out. These dates are not launch dates: a court ruling or a settlement can bring a generic forward.

BrandGeneric approved?First patent challengeExclusivity runs toPatent on the medicine runs toLast listed patent runs to
OzempicNot yet: tentative onlyDec 6, 2021Oct 17, 2028Dec 5, 2031Feb 17, 2041
WegovyNoOct 20, 2022Mar 19, 2029Dec 5, 2031Feb 17, 2041
RybelsusNoJul 15, 2024Oct 17, 2028May 2, 2034Feb 1, 2039
MounjaroNoMay 13, 2026Dec 19, 2028Jun 14, 2039Dec 30, 2041
ZepboundNoMay 13, 2026Dec 20, 2027May 13, 2036Jul 22, 2039
FoundayoNoNone listedApr 1, 2031Sep 26, 2037Sep 26, 2037
VictozaYes, 8Dec 12, 2016None listedNone listedJul 9, 2037
SaxendaYes, 3Aug 16, 2021None listedNone listedJul 9, 2037
TrulicityNo, it is a biologicNone listedNone listedNone listedNone listed
ByettaDiscontinuedJun 11, 2014None listedNone listedNone listed
BydureonNoNone listedNone listedNone listedApr 4, 2031

No generic approved does not mean nobody has applied: FDA does not disclose an application before it acts on it, unless it was already made public. Trulicity is a biologic, so the Orange Book does not list it.

Every decision

Every generic GLP-1 FDA has acted on

11 on FDA's approved list, 1 tentative, 1 discontinued.

CompanyA copy ofFDA's decisionOnRatingFDA record
SandozVictozaApprovedJul 1, 2026AP1ANDA212972
Mylan InstitutionalVictozaApprovedJun 15, 2026AP1ANDA213155
ApotexOzempicTentative: cannot be soldApr 7, 2026NoneANDA220314
Fresenius Kabi USAVictozaApprovedMar 30, 2026AP1ANDA212552
Biocon PharmaVictozaApprovedMar 11, 2026AP1ANDA215245
Biocon PharmaSaxendaApprovedFeb 24, 2026AP2ANDA217063
Orbicular Pharmaceutical Technologies PrivateSaxendaApprovedFeb 24, 2026AP2ANDA217234
Orbicular Pharmaceutical Technologies PrivateVictozaApprovedJan 14, 2026AP1ANDA217590
Teva Pharmaceuticals DevelopmentSaxendaApprovedAug 27, 2025AP2ANDA214568
LupinVictozaApprovedJul 22, 2025AP1ANDA215421
Nanjing King Friend Biochemical PharmaceuticalVictozaApprovedApr 2, 2025AP1ANDA218115
Hikma Pharmaceuticals USAVictozaApprovedDec 23, 2024AP1ANDA215503
Amneal EUByettaApproved, now discontinuedNov 19, 2024NoneANDA206697

What they cost: generic Victoza from ~$98 per 2 pens at SingleCare; generic Saxenda from ~$372/mo at GoodRx. Every liraglutide price

The line at FDA

Who has challenged which patents

A generic maker can ask FDA for approval before a patent runs out by stating that the patent is invalid, unenforceable or not infringed. FDA calls this a paragraph IV certification. It is a filing, not an approval.

BrandStrengthsFirst challengeApplications that dayFirst generic approvedLast qualifying patent
Wegovy25 mgAug 28, 20261None yetFeb 1, 2039
Zepbound40 mg/2.4 mL and 50 mg/2.4 mLAug 26, 20261None yetJul 22, 2039
Mounjaro20 mg/2.4 mL and 30 mg/2.4 mLAug 24, 20261None yetDec 30, 2041
Zepbound20 mg/2.4 mL and 30 mg/2.4 mLAug 24, 20261None yetJul 22, 2039
Mounjaro10 mg/2.4 mL and 60 mg/2.4 mLJun 26, 20261None yetDec 30, 2041
Zepbound10 mg/2.4 mL and 60 mg/2.4 mLJun 26, 20261None yetJul 22, 2039
Wegovy7.2 mg/0.75 mLJun 22, 20261None yetFeb 17, 2041
Mounjaro2.5 mg/0.5 mL 5 mg/0.5 mLMay 13, 202613None yetDec 30, 2041
Mounjaro7.5 mg/0.5 mLMay 13, 202613None yetDec 30, 2041
Mounjaro10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mLMay 13, 202612None yetDec 30, 2041
Zepbound2.5 mg/0.5 mL 5 mg/0.5 mLMay 13, 202612None yetJul 22, 2039
Zepbound7.5 mg/0.5 mLMay 13, 202612None yetJul 22, 2039
Zepbound10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mLMay 13, 202611None yetJul 22, 2039
Zepbound2.5 mg/0.5 mL 5 mg/0.5 mLMay 13, 20263None yetJul 22, 2039
Mounjaro2.5 mg/0.5 mL 5mg/0.5 mL 7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mLMay 13, 20262None yetDec 30, 2041
Zepbound7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mLMay 13, 20262None yetJul 22, 2039
Mounjaro12.5 mg/0.5 mLMay 13, 20261None yetDec 30, 2041
Zepbound12.5 mg/0.5 mLMay 13, 20261None yetJul 22, 2039
Wegovy1.5 mg, 4 mg and 9 mgMar 11, 20261None yetFeb 1, 2039
Ozempic1.5 mg, 4 mg and 9 mgDec 11, 20251None yetFeb 1, 2039
Rybelsus3 mg, 7 mg and 14 mgJul 15, 20241None yetMay 2, 2034
Ozempic2 mg/3 mLApr 11, 20241None yetJun 21, 2033
Ozempic8 mg/3 mLDec 21, 20221None yetFeb 1, 2032
Wegovy0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mLOct 20, 20221None yetFeb 17, 2041
Ozempic2 mg/1.5 mL and 4 mg/3 mLDec 6, 20217None yetJun 21, 2033
Saxenda18 mg/3 mL prefilled syringeAug 16, 20211Aug 27, 2025Jan 9, 2037
Victoza18 mg/3 mL prefilled syringeDec 12, 20161None yetSep 23, 2032
Byetta250 mg/mL, 1.2 mL and 2.4 mL prefilled syringeJun 11, 20141None yetJan 14, 2020

6 of the brands without an approved generic have been challenged. A new chemical entity has five years of exclusivity, but a generic maker may file after four years if it challenges a patent. Ozempic's first challenge came on Dec 6, 2021, 7 applications on the first day they could. Mounjaro's first challenge came on May 13, 2026, 13 applications on the first day they could.

Why they rush: the first to file a complete challenge is generally eligible to sell the generic alone for 180 days. If the patent holder sues within 45 days, FDA approval is generally postponed for 30 months unless the patent expires or is judged invalid or not infringed first. All of this is as FDA describes it, which also says it decides on the applications themselves, not on this list.

What stands in the way

Each brand's patents and exclusivity

Every patent and exclusivity FDA lists for each brand and not yet run out. The maker declares its patents, and FDA says its role in listing them is ministerial, so a listing does not mean a court has upheld the patent.

Is there a generic Ozempic?

Not yet. FDA tentatively approved a generic of Ozempic from Apotex on Apr 7, 2026, and FDA says a product with a tentative approval is not an approved drug product, so it cannot be sold.

  • Exclusivity to Jan 28, 2028: To reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease (I-961)
  • Exclusivity to Oct 17, 2028: To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events (I-976)
23 listed patents, the last running to Feb 17, 2041
  • 8129343, to Dec 5, 2031, covers the medicine itself, the product, a use
  • 9278123, to Dec 16, 2031, covers the medicine itself, the product, a use
  • 11382957, to Dec 16, 2031, covers the medicine itself, the product
  • 10960052, to Dec 16, 2031, covers the product
  • 10086047, to Dec 16, 2031, covers the product
  • 10933120, to Mar 15, 2033, covers the product
  • 11759501, to Mar 15, 2033, covers the product
  • 11759502, to Mar 15, 2033, covers the product
  • 11759503, to Mar 15, 2033, covers the product
  • 12594326, to Mar 15, 2033, covers the product
  • 11033499, to Jun 19, 2033, covers the product, a use
  • 10335462, to Jun 21, 2033, covers the product, a use
  • 10278923, to May 2, 2034, covers the medicine itself, the product, a use
  • 12514822, to May 2, 2034, covers a use
  • 12239739, to May 2, 2034, covers the medicine itself, the product, a use
  • 12569543, to Apr 28, 2037, covers a use
  • 12214017, to Aug 24, 2038, covers the product, a use
  • 11752198, to Aug 24, 2038, covers the product, a use
  • 10888605, to Aug 24, 2038, covers the product, a use
  • 12295988, to Oct 10, 2038, covers a use
  • 11833248, to Feb 1, 2039, covers the product, a use
  • 12396953, to Feb 1, 2039, covers the product, a use
  • 11318191, to Feb 17, 2041, covers the product, a use

FDA record NDA209637 · FDA record NDA213051

Is there a generic Wegovy?

No. FDA has not approved a generic of Wegovy.

  • Exclusivity to Mar 8, 2027: In combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight (I-935)
  • Exclusivity to Aug 15, 2028: Treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (nash), with moderate to advanced liver fibrosis (consistent with stages f2 to f3 fibrosis) in adults (I-973)
  • Exclusivity to Dec 22, 2028: New product (NP)
  • Exclusivity to Mar 19, 2029: New strength (NS)
17 listed patents, the last running to Feb 17, 2041
  • 8129343, to Dec 5, 2031, covers the medicine itself, the product
  • 9278123, to Dec 16, 2031, covers the product, a use
  • 11382957, to Dec 16, 2031, covers the product
  • 11033499, to Jun 19, 2033, covers the product, a use
  • 9764003, to Jun 21, 2033, covers a use
  • 12239739, to May 2, 2034, covers a use
  • 10278923, to May 2, 2034, covers a use
  • 12569543, to Apr 28, 2037, covers a use
  • 12214017, to Aug 24, 2038, covers the product, a use
  • 11752198, to Aug 24, 2038, covers the product, a use
  • 10888605, to Aug 24, 2038, covers the product, a use
  • 12551536, to Oct 10, 2038, covers a use
  • 12029779, to Oct 10, 2038, covers a use
  • 12396953, to Feb 1, 2039, covers the product, a use
  • 11833248, to Feb 1, 2039, covers the product, a use
  • 11478533, to May 13, 2040, covers a use
  • 11318191, to Feb 17, 2041, covers the product, a use

FDA record NDA215256 · FDA record NDA218316

Is there a generic Rybelsus?

No. FDA has not approved a generic of Rybelsus.

  • Exclusivity to Oct 17, 2028: To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events (I-976)
16 listed patents, the last running to Feb 1, 2039
  • 8129343, to Dec 5, 2031, covers the medicine itself, the product, a use
  • 9278123, to Dec 16, 2031, covers the medicine itself, the product, a use
  • 11382957, to Dec 16, 2031, covers the medicine itself, the product
  • 10960052, to Dec 16, 2031, covers the product
  • 10086047, to Dec 16, 2031, covers the product
  • 10933120, to Mar 15, 2033, covers the product
  • 11759501, to Mar 15, 2033, covers the product
  • 11759502, to Mar 15, 2033, covers the product
  • 11759503, to Mar 15, 2033, covers the product
  • 12594326, to Mar 15, 2033, covers the product
  • 11033499, to Jun 19, 2033, covers the product, a use
  • 10278923, to May 2, 2034, covers the medicine itself, the product, a use
  • 12514822, to May 2, 2034, covers a use
  • 12239739, to May 2, 2034, covers the medicine itself, the product, a use
  • 11833248, to Feb 1, 2039, covers the product, a use
  • 12396953, to Feb 1, 2039, covers the product, a use

FDA record NDA213051

Is there a generic Mounjaro?

No. FDA has not approved a generic of Mounjaro.

  • Exclusivity to May 13, 2027: New chemical entity (NCE)
  • Exclusivity to Dec 19, 2028: New patient population (NPP)
8 listed patents, the last running to Dec 30, 2041
  • 9474780, to May 13, 2036, covers the medicine itself, the product, a use
  • 12453755, to Jun 14, 2039, covers a use
  • 12629404, to Jun 14, 2039, covers the product, a use
  • 12453756, to Jun 14, 2039, covers the product
  • 11357820, to Jun 14, 2039, covers the medicine itself, the product
  • 12343382, to Jul 22, 2039, covers a use
  • 12616740, to Jul 22, 2039, covers a use
  • 12295987, to Dec 30, 2041, covers a use

FDA record NDA215866

Is there a generic Zepbound?

No. FDA has not approved a generic of Zepbound.

  • Exclusivity to Nov 8, 2026: New product (NP)
  • Exclusivity to May 13, 2027: New chemical entity (NCE)
  • Exclusivity to Oct 18, 2027: Labeling revisions related to clinical studies (M-82)
  • Exclusivity to Dec 20, 2027: Treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity (I-958)
8 listed patents, the last running to Jul 22, 2039
  • 9474780, to May 13, 2036, covers the medicine itself, the product
  • 11918623, to Jun 14, 2039, covers a use
  • 12629404, to Jun 14, 2039, covers the product, a use
  • 11357820, to Jun 14, 2039, covers the product
  • 12453756, to Jun 14, 2039, covers the product
  • 12343382, to Jul 22, 2039, covers a use
  • 12453758, to Jul 22, 2039, covers a use
  • 12616740, to Jul 22, 2039, covers a use

FDA record NDA217806

Is there a generic Foundayo?

No. FDA has not approved a generic of Foundayo.

  • Exclusivity to Apr 1, 2031: New chemical entity (NCE)
1 listed patent, the last running to Sep 26, 2037
  • RE50455, to Sep 26, 2037, covers the medicine itself, the product, a use

FDA record NDA220934

Is there a generic Victoza?

Yes. FDA has approved 8 generics of Victoza, the first from Hikma Pharmaceuticals USA on Dec 23, 2024.

1 listed patent, the last running to Jul 9, 2037
  • 9968659, to Jul 9, 2037, covers a use

FDA record NDA022341

Is there a generic Saxenda?

Yes. FDA has approved 3 generics of Saxenda, the first from Teva Pharmaceuticals Development on Aug 27, 2025.

1 listed patent, the last running to Jul 9, 2037
  • 9968659, to Jul 9, 2037, covers a use

FDA record NDA206321

Is there a generic Trulicity?

No. Trulicity is licensed as a biologic, so a copy would be a biosimilar, and FDA's record holds no application for one.

FDA record BLA125469

Is there a generic Byetta?

Not any more. FDA approved a generic of Byetta from Amneal EU on Nov 19, 2024, and it is now listed as discontinued. So is Byetta itself.

FDA record NDA021773

Is there a generic Bydureon?

No. Bydureon itself is listed as discontinued, and FDA has not approved a generic of it.

6 listed patents, the last running to Apr 4, 2031
  • 8329648, to Feb 18, 2027, covers a use
  • 8906851, to Feb 18, 2027, covers a use
  • 9884092, to Feb 18, 2027, covers a use
  • 8501698, to Dec 20, 2027, covers the product, a use
  • 8361972, to Sep 21, 2028, covers a use
  • 8895033, to Apr 4, 2031, covers the product, a use

FDA record NDA022200 · FDA record NDA209210

Exclusivity codes and their wording are FDA's own.

Outside the United States

Generic semaglutide in Canada

Health Canada is the first G7 regulator to approve one. Checked Nov 6, 2026; it said in June 2026 that it was reviewing six more.

  • Apr 28, 2026: Dr. Reddy's Laboratories, a generic of Ozempic, for type 2 diabetes. Health Canada
  • May 1, 2026: Apotex, a generic of Ozempic, for type 2 diabetes. Health Canada
  • Jun 29, 2026: Apotex (Sevmia), a generic of Wegovy, for chronic weight management, age 12 and over. Health Canada

That does not make them legal to bring home. FDA says: “In most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use”, and that it cannot ensure the safety of medicine bought from foreign sources. FDA on personal importation

What the words mean

Generic, tentative, patent, exclusivity

Generic
An FDA-approved copy of a brand, with the same active ingredient, strength, form and route, that must work the same way in the body.
Tentative approval
FDA's Orange Book is plain about this: a product granted one “is not an approved drug product”. It is listed only once the approval becomes final.
Rating (AP1, AP2)
FDA's therapeutic equivalence code. The number appears when more than one reference product of the same strength is listed, which is how a Victoza generic and a Saxenda generic are told apart: both are 18 mg/3 mL liraglutide.
Patent
A property right granted by the US Patent and Trademark Office, generally for 20 years from filing. It can be issued or expire at any time, and it can cover the medicine, the product or a way of using it.
Exclusivity
A delay on approving competitors that attaches when FDA approves a drug: 5 years for a new chemical entity, 3 years for a new clinical investigation. It is separate from patents and may or may not run alongside them.
Compounded
Not a generic. A compounded medicine is mixed by a pharmacy without FDA approval. Compounded prices and FDA's position
Updated automatically

Latest generic challenges and patent listings

Written from each source's own record as it changes. Every change on GLPcompare

Questions

Generic GLP-1s: common questions

Is there a generic Ozempic?

Not yet. FDA tentatively approved a generic of Ozempic from Apotex on Apr 7, 2026, and FDA says a product with a tentative approval is not an approved drug product, so it cannot be sold. Generic makers first challenged its patents on Dec 6, 2021, with 7 applications that day. Its FDA exclusivity runs to Oct 17, 2028. Its patent on the medicine itself runs to Dec 5, 2031, and its last listed patent to Feb 17, 2041. These dates are not a launch date: a court ruling or a settlement can bring one forward.

Is there a generic Wegovy?

No. FDA has not approved a generic of Wegovy. Generic makers first challenged its patents on Oct 20, 2022. Its FDA exclusivity runs to Mar 19, 2029. Its patent on the medicine itself runs to Dec 5, 2031, and its last listed patent to Feb 17, 2041. These dates are not a launch date: a court ruling or a settlement can bring one forward.

Is there a generic Rybelsus?

No. FDA has not approved a generic of Rybelsus. Generic makers first challenged its patents on Jul 15, 2024. Its FDA exclusivity runs to Oct 17, 2028. Its patent on the medicine itself runs to May 2, 2034, and its last listed patent to Feb 1, 2039. These dates are not a launch date: a court ruling or a settlement can bring one forward.

Is there a generic Mounjaro?

No. FDA has not approved a generic of Mounjaro. Generic makers first challenged its patents on May 13, 2026, with 13 applications that day. Its FDA exclusivity runs to Dec 19, 2028. Its patent on the medicine itself runs to Jun 14, 2039, and its last listed patent to Dec 30, 2041. These dates are not a launch date: a court ruling or a settlement can bring one forward.

Is there a generic Zepbound?

No. FDA has not approved a generic of Zepbound. Generic makers first challenged its patents on May 13, 2026, with 12 applications that day. Its FDA exclusivity runs to Dec 20, 2027. Its patent on the medicine itself runs to May 13, 2036, and its last listed patent to Jul 22, 2039. These dates are not a launch date: a court ruling or a settlement can bring one forward.

Is there a generic Foundayo?

No. FDA has not approved a generic of Foundayo. Its FDA exclusivity runs to Apr 1, 2031. Its patent on the medicine itself runs to Sep 26, 2037. These dates are not a launch date: a court ruling or a settlement can bring one forward.

Is there a generic Victoza?

Yes. FDA has approved 8 generics of Victoza, the first from Hikma Pharmaceuticals USA on Dec 23, 2024.

Is there a generic Saxenda?

Yes. FDA has approved 3 generics of Saxenda, the first from Teva Pharmaceuticals Development on Aug 27, 2025.

Is there a generic Trulicity?

No. Trulicity is licensed as a biologic, so a copy would be a biosimilar, and FDA's record holds no application for one.

Is there a generic Byetta?

Not any more. FDA approved a generic of Byetta from Amneal EU on Nov 19, 2024, and it is now listed as discontinued. So is Byetta itself. Generic makers first challenged its patents on Jun 11, 2014.

When will generic Ozempic or Wegovy be available?

FDA does not publish a date, and neither of these dates is one. Ozempic's listed patent on semaglutide itself runs to Dec 5, 2031. A generic needs FDA's final approval, and patents can expire, be struck down in court or be licensed in a settlement, so a generic could come sooner or be held back by a later patent.

Is there a generic semaglutide in Canada?

Yes. Health Canada approved Dr. Reddy's Laboratories's on Apr 28, 2026, Apotex's on May 1, 2026, Apotex (Sevmia)'s on Jun 29, 2026. FDA says that in most circumstances it is illegal for individuals to import drugs into the US for personal use.

Is compounded semaglutide or tirzepatide a generic?

No. A generic is a copy FDA has approved and rated against the brand. A compounded medicine is mixed by a pharmacy and has no FDA approval, so FDA has not reviewed it for safety, effectiveness or quality.

Is generic liraglutide the same as Victoza or Saxenda?

FDA rates each of them therapeutically equivalent to one brand, shown by a code: AP1 for Victoza and AP2 for Saxenda. FDA says products with that rating can be expected to have the same clinical effect and safety profile. A generic carries its brand's label information, with certain exceptions FDA allows, so a Victoza generic is for what Victoza is for and a Saxenda generic for what Saxenda is for.

This page reports FDA's public records. It is not legal advice or a forecast of when any generic will reach the market.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.