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. 1 generic application already holds tentative FDA approval, meaning the FDA has judged it acceptable and it is waiting on these dates.
Generics already cleared and waiting
A tentative approval means the FDA has already judged the generic to meet its standards but cannot allow marketing yet.
- APOTEX INC tentative approval 2026, application ANDA220314
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 | RYBELSUS |
| 8536122 | 2026-03-20 | drug substance, drug product | OZEMPIC |
| 8536122 | 2026-03-20 | drug substance, drug product | WEGOVY |
| 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 | OZEMPIC |
| 8129343 | 2031-12-05 | drug substance, drug product | RYBELSUS |
| 8129343 | 2031-12-05 | drug substance, drug product | WEGOVY |
| 8129343 | 2031-12-05 | drug substance, drug product | WEGOVY HD |
| 8129343 | 2031-12-05 | drug substance, drug product | WEGOVY FLEXTOUCH |
| 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 |
| 11382957 | 2031-12-16 | drug product | WEGOVY |
| 9278123 | 2031-12-16 | drug product | WEGOVY |
| 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 | RYBELSUS |
| 11033499 | 2033-06-19 | drug product | OZEMPIC |
| 11033499 | 2033-06-19 | drug product | WEGOVY |
| 10335462 | 2033-06-21 | method of use | OZEMPIC |
| 9764003 | 2033-06-21 | method of use | WEGOVY |
| 9764003 | 2033-06-21 | method of use | WEGOVY HD |
| 9764003 | 2033-06-21 | method of use | WEGOVY FLEXTOUCH |
| 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 |
| 10278923 | 2034-05-02 | method of use | WEGOVY |
| 12239739 | 2034-05-02 | method of use | WEGOVY |
| 12569543 | 2037-04-28 | method of use | OZEMPIC |
| 12569543 | 2037-04-28 | method of use | WEGOVY |
| 10888605 | 2038-08-24 | drug product | OZEMPIC |
| 11752198 | 2038-08-24 | drug product | OZEMPIC |
| 12214017 | 2038-08-24 | drug product | OZEMPIC |
| 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 | WEGOVY HD |
| 11752198 | 2038-08-24 | drug product | WEGOVY HD |
| 12214017 | 2038-08-24 | drug product | WEGOVY HD |
| 12295988 | 2038-10-10 | method of use | OZEMPIC |
| 12029779 | 2038-10-10 | method of use | WEGOVY |
| 12551536 | 2038-10-10 | method of use | WEGOVY |
| 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 FLEXTOUCH |
| 12551536 | 2038-10-10 | method of use | WEGOVY FLEXTOUCH |
| 11833248 | 2039-02-01 | drug product | OZEMPIC |
| 12396953 | 2039-02-01 | drug product | OZEMPIC |
| 11833248 | 2039-02-01 | drug product | WEGOVY |
| 12396953 | 2039-02-01 | drug product | WEGOVY |
| 11478533 | 2040-05-13 | method of use | WEGOVY |
| 11478533 | 2040-05-13 | method of use | WEGOVY FLEXTOUCH |
| 11318191 | 2041-02-17 | drug product | OZEMPIC |
| 11318191 | 2041-02-17 | drug product | WEGOVY |
| 11318191 | 2041-02-17 | drug product | WEGOVY HD |
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 |
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. 1 generic application already holds tentative FDA approval, meaning the FDA has judged it acceptable and it is waiting on these dates.
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 2026-09-23. 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.