Home / Generic availability / Semaglutide
When will generic Semaglutide be available?
Based on the patents and exclusivity the FDA lists today, generic semaglutide cannot be marketed in the United States before 2041-02-17, when the last listed protection expires.
Patents listed with the FDA
63 unexpired or current listing(s), plus 13 delisted. A delisted patent no longer blocks a generic.
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10357616 delisted | 2026-01-20 | drug product | OZEMPIC |
| 10376652 delisted | 2026-01-20 | drug product | OZEMPIC |
| 9108002 delisted | 2026-01-20 | drug product | OZEMPIC |
| 9616180 delisted | 2026-01-20 | drug product | OZEMPIC |
| 9861757 delisted | 2026-01-20 | drug product | OZEMPIC |
| 8536122 | 2026-03-20 | drug substance, drug product | OZEMPIC |
| 8536122 | 2026-03-20 | drug substance, drug product | WEGOVY |
| 8536122 | 2026-03-20 | drug substance, drug product | RYBELSUS |
| 10220155 delisted | 2026-07-17 | drug product | OZEMPIC |
| 11097063 delisted | 2026-07-17 | drug product | OZEMPIC |
| 8920383 delisted | 2026-07-17 | drug product | OZEMPIC |
| 9775953 delisted | 2026-07-17 | drug product | OZEMPIC |
| RE46363 delisted | 2026-08-03 | drug product | OZEMPIC |
| 9687611 delisted | 2027-02-27 | drug product | OZEMPIC |
| 9457154 delisted | 2027-09-29 | drug product | OZEMPIC |
| 8129343 | 2031-12-05 | drug substance, drug product | WEGOVY HD |
| 8129343 | 2031-12-05 | drug substance, drug product | WEGOVY |
| 8129343 | 2031-12-05 | drug substance, drug product | OZEMPIC |
| 8129343 | 2031-12-05 | drug substance, drug product | WEGOVY FLEXTOUCH |
| 8129343 | 2031-12-05 | drug substance, drug product | RYBELSUS |
| 11382957 | 2031-12-16 | drug product | WEGOVY |
| 9278123 | 2031-12-16 | drug product | WEGOVY |
| 10086047 | 2031-12-16 | drug product | RYBELSUS |
| 10960052 | 2031-12-16 | drug product | RYBELSUS |
| 11382957 | 2031-12-16 | drug product | RYBELSUS |
| 9278123 | 2031-12-16 | drug product | RYBELSUS |
| 11382957 | 2031-12-16 | drug substance, drug product | OZEMPIC |
| 9278123 | 2031-12-16 | drug substance, drug product | OZEMPIC |
| 9132239 delisted | 2032-02-01 | drug product | OZEMPIC |
| 10933120 | 2033-03-15 | drug product | RYBELSUS |
| 11759501 | 2033-03-15 | drug product | RYBELSUS |
| 11759502 | 2033-03-15 | drug product | RYBELSUS |
| 11759503 | 2033-03-15 | drug product | RYBELSUS |
| 12594326 | 2033-03-15 | drug product | RYBELSUS |
| 11033499 | 2033-06-19 | drug product | WEGOVY |
| 11033499 | 2033-06-19 | drug product | RYBELSUS |
| 11033499 | 2033-06-19 | drug product | OZEMPIC |
| 9764003 | 2033-06-21 | method of use | WEGOVY HD |
| 9764003 | 2033-06-21 | method of use | WEGOVY |
| 10335462 | 2033-06-21 | method of use | OZEMPIC |
| 9764003 | 2033-06-21 | method of use | WEGOVY FLEXTOUCH |
| 10278923 | 2034-05-02 | method of use | WEGOVY |
| 12239739 | 2034-05-02 | method of use | WEGOVY |
| 10278923 | 2034-05-02 | method of use | RYBELSUS |
| 12239739 | 2034-05-02 | drug substance, drug product | RYBELSUS |
| 12514822 | 2034-05-02 | method of use | RYBELSUS |
| 10278923 | 2034-05-02 | drug substance, drug product | OZEMPIC |
| 12239739 | 2034-05-02 | drug substance, drug product | OZEMPIC |
| 12514822 | 2034-05-02 | method of use | OZEMPIC |
| 12569543 | 2037-04-28 | method of use | WEGOVY |
| 12569543 | 2037-04-28 | method of use | OZEMPIC |
| 10888605 | 2038-08-24 | drug product | WEGOVY HD |
| 11752198 | 2038-08-24 | drug product | WEGOVY HD |
| 12214017 | 2038-08-24 | drug product | WEGOVY HD |
| 10888605 | 2038-08-24 | drug product | WEGOVY |
| 11752198 | 2038-08-24 | drug product | WEGOVY |
| 12214017 | 2038-08-24 | drug product | WEGOVY |
| 10888605 | 2038-08-24 | drug product | OZEMPIC |
| 11752198 | 2038-08-24 | drug product | OZEMPIC |
| 12214017 | 2038-08-24 | drug product | OZEMPIC |
| 12029779 | 2038-10-10 | method of use | WEGOVY HD |
| 12551536 | 2038-10-10 | method of use | WEGOVY HD |
| 12029779 | 2038-10-10 | method of use | WEGOVY |
| 12551536 | 2038-10-10 | method of use | WEGOVY |
| 12295988 | 2038-10-10 | method of use | OZEMPIC |
| 12029779 | 2038-10-10 | method of use | WEGOVY FLEXTOUCH |
| 12551536 | 2038-10-10 | method of use | WEGOVY FLEXTOUCH |
| 11833248 | 2039-02-01 | drug product | WEGOVY |
| 12396953 | 2039-02-01 | drug product | WEGOVY |
| 11833248 | 2039-02-01 | drug product | OZEMPIC |
| 12396953 | 2039-02-01 | drug product | OZEMPIC |
| 11478533 | 2040-05-13 | method of use | WEGOVY |
| 11478533 | 2040-05-13 | method of use | WEGOVY FLEXTOUCH |
| 11318191 | 2041-02-17 | drug product | WEGOVY HD |
| 11318191 | 2041-02-17 | drug product | WEGOVY |
| 11318191 | 2041-02-17 | drug product | OZEMPIC |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| D-190 | 2026-07-21 | Exclusivity tied to a specific labelling or study change | WEGOVY |
| I-935 | 2027-03-08 | New indication (3 years) | WEGOVY |
| I-935 | 2027-03-08 | New indication (3 years) | WEGOVY FLEXTOUCH |
| I-961 | 2028-01-28 | New indication (3 years) | OZEMPIC |
| I-973 | 2028-08-15 | New indication (3 years) | WEGOVY |
| I-973 | 2028-08-15 | New indication (3 years) | WEGOVY FLEXTOUCH |
| I-976 | 2028-10-17 | New indication (3 years) | RYBELSUS |
| I-976 | 2028-10-17 | New indication (3 years) | OZEMPIC |
| NP | 2028-12-22 | New product | WEGOVY |
| NS | 2029-03-19 | New strength | WEGOVY HD |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| OZEMPIC | Brand (NDA) | NOVO NORDISK INC | 2017-12-05 | reference listed drug, reference standard |
| OZEMPIC, RYBELSUS | Brand (NDA) | NOVO NORDISK INC | 2019-09-20 | reference listed drug, reference standard |
| WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | Brand (NDA) | NOVO NORDISK INC | 2021-06-04 | reference listed drug, reference standard |
| WEGOVY | Brand (NDA) | NOVO NORDISK INC | 2025-12-22 | reference listed drug, reference standard |
What a generic Semaglutide would have to match
Forms and strengths
Injection: clear, colorless solution available as follows: Single-Patient-Use Pens (with multiple weekly doses) Dose per Injection Total Strength per Total Volume Strength per mL 0.25 mg 0.5 mg 2 mg / 3 mL 0.68 mg/mL 1 mg 4 mg / 3 mL 1.34 mg/mL 2 mg 8 mg / 3 mL 2.68 mg/mL Single-Dose Prefilled Syringes Dose per Injection Total Strength per Total Volume 0.25 mg 0.25 mg / 0.5 mL 0.5 mg 0.5 mg / 0.5 mL 1 mg 1 mg / 0.5 mL • Injection: 2 mg/3 mL (0.68 mg/mL) for 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg, 4 mg/3 mL (1.34 mg/mL) for 4 doses of 1 mg, and 8 mg/3 mL (2.68 mg/mL) for 4 doses of 2 mg in single-patient-use pens ( 3 ) • Injection: 0.25 mg, 0.5 mg or 1 mg per 0.5 mL in a single-dose prefilled syringe ( 3 )
How it is supplied
Product: 50090-8027 NDC: 50090-8027-0 3 mL in a SYRINGE, PLASTIC / 1 in a CARTON
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-07-30.
Recalls involving Semaglutide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Carolina Infusion, LLC | SC | Class II | 2026-09-10 | Lack of Assurance of Sterility: Related to formulation using bacterios |
| Apollo Care, LLC | MO | Class II | 2026-07-29 | Presence of Particulate Matter; identified as a nylon/polyamide and si |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Lanreotideprotection runs to March 2027
- Tirzepatideprotection runs to May 2027
- Octreotideprotection runs to June 2027
- Terlipressinprotection runs to September 2027
- Abaloparatideprotection runs to October 2027
Frequently asked questions
When will generic Semaglutide be available?
Based on the patents and exclusivity the FDA lists today, generic semaglutide cannot be marketed in the United States before 2041-02-17, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
Related data
- Semaglutide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book
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