FDA Orange Book
Is there a generic for Ozempic?
Ozempic contains semaglutide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ozempic (semaglutide). The Orange Book shows its last listed patent expires February 17, 2041 and its last listed exclusivity ends October 17, 2028.
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Ozempic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 0.25MG/0.5ML (0.25MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 0.5MG/0.5ML (0.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 1MG/0.5ML (1MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 2MG/1.5ML (1.34MG/ML) | Discontinued | None | 0 | None |
| solution, subcutaneous | 2MG/3ML (0.68MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 4MG/3ML (1.34MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 8MG/3ML (2.68MG/ML) | Marketed (Rx) | None | 0 | None |
| tablet, oral | 1.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 4MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 209637, 213051, held by NOVO NORDISK INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ozempic patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10376652 | January 20, 2026 | Drug product | None | 209637 |
| 9861757 | January 20, 2026 | Drug product | None | 209637 |
| 9616180 | January 20, 2026 | Drug product | None | 209637 |
| 10357616 | January 20, 2026 | Drug product | None | 209637 |
| 9108002 | January 20, 2026 | Drug product | None | 209637 |
| 8536122 | March 20, 2026 | Drug substance, Drug product | U-2202 | 209637 |
| 8536122 | March 20, 2026 | Drug substance, Drug product | U-3469 | 209637 |
| 8536122 | March 20, 2026 | Drug substance, Drug product | U-3355 | 209637 |
| 8536122 | March 20, 2026 | Drug substance, Drug product | U-2628 | 213051 |
| 8920383 | July 17, 2026 | Drug product | None | 209637 |
| 9775953 | July 17, 2026 | Drug product | None | 209637 |
| 11097063 | July 17, 2026 | Drug product | None | 209637 |
| 10220155 | July 17, 2026 | Drug product | None | 209637 |
| RE46363 | August 3, 2026 | Drug product | None | 209637 |
| 9687611 | February 27, 2027 | Drug product | None | 209637 |
| 9457154 | September 29, 2027 | Drug product | None | 209637 |
| 8129343 | December 5, 2031 | Drug substance, Drug product | U-3355 | 209637 |
| 8129343 | December 5, 2031 | Drug substance, Drug product | U-2202 | 209637 |
| 8129343 | December 5, 2031 | Drug substance, Drug product | U-3469 | 209637 |
| 8129343 | December 5, 2031 | Drug substance, Drug product | U-2628 | 213051 |
| 11382957 | December 16, 2031 | Drug substance, Drug product | None | 213051 |
| 9278123 | December 16, 2031 | Drug substance, Drug product | U-2628 | 213051 |
| 9132239 | February 1, 2032 | Drug product | None | 209637 |
| 11033499 | June 19, 2033 | Drug product | U-2628 | 213051 |
| 10335462 | June 21, 2033 | Method of use | U-1852 | 209637 |
| 10335462 | June 21, 2033 | Method of use | U-2580 | 209637 |
| 12514822 | May 2, 2034 | Method of use | U-2628 | 213051 |
| 12239739 | May 2, 2034 | Drug substance, Drug product | U-2628 | 213051 |
| 10278923 | May 2, 2034 | Drug substance, Drug product | U-2628 | 213051 |
| 12569543 | April 28, 2037 | Method of use | U-4446 | 209637 |
| 12214017 | August 24, 2038 | Drug product | U-1852 | 209637 |
| 11752198 | August 24, 2038 | Drug product | U-1852 | 209637 |
| 10888605 | August 24, 2038 | Drug product | U-1852 | 209637 |
| 12295988 | October 10, 2038 | Method of use | U-1852 | 209637 |
| 12295988 | October 10, 2038 | Method of use | U-2628 | 209637 |
| 11833248 | February 1, 2039 | Drug product | U-2628 | 213051 |
| 12396953 | February 1, 2039 | Drug product | U-2628 | 213051 |
| 11318191 | February 17, 2041 | Drug product | U-1852 | 209637 |
| 11318191 | February 17, 2041 | Drug product | U-4561 | 209637 |
Ozempic exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-961 | New indication | January 28, 2028 | 209637 |
| I-976 | New indication | October 17, 2028 | 213051 |
Ozempic NDC codes
Questions
Is there a generic for Ozempic?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ozempic (semaglutide). The Orange Book shows its last listed patent expires February 17, 2041 and its last listed exclusivity ends October 17, 2028.
What is the generic name for Ozempic?
The active ingredient in Ozempic is semaglutide, per the FDA Orange Book.
When does the Ozempic patent expire?
The last patent listed for Ozempic in the Orange Book expires February 17, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Ozempic and Semaglutide
- What is Ozempic used for?FDA label uses
- Is Ozempic a controlled substance?Federal schedule
- Generic for WegovyFDA Orange Book
- Generic for Wegovy FlextouchFDA Orange Book
- Generic for Wegovy HdFDA Orange Book
- Generic for RybelsusFDA Orange Book
- GLP-1 Receptor Agonists listFDA drug class
- Ozempic Medicare Part D coverageBy plan and state
- NDC 0169-1704Ozempic NDC record
- NDC 0169-1709Ozempic NDC record
- NDC 0169-1715Ozempic NDC record