FDA Orange Book
Is there a generic for Wegovy?
Wegovy 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 Wegovy (semaglutide). The Orange Book shows its last listed patent expires February 17, 2041 and its last listed exclusivity ends December 22, 2028.
Run it in Rivvi
Map Wegovy and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Wegovy 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 | 0.25MG/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 | 0.5MG/0.5ML (0.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 1.7MG/0.75ML (1.7MG/0.75ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 1.7MG/0.75ML (1.7MG/0.75ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 1MG/0.5ML (1MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 1MG/0.5ML (1MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 2.4MG/0.75ML (2.4MG/0.75ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 2.4MG/0.75ML (2.4MG/0.75ML) | Marketed (Rx) | None | 0 | None |
| tablet, oral | 1.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 4MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 215256, 218316, 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.
Wegovy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8536122 | March 20, 2026 | Drug substance, Drug product | None | 215256 |
| 8129343 | December 5, 2031 | Drug substance, Drug product | None | 215256 |
| 11382957 | December 16, 2031 | Drug product | None | 218316 |
| 9278123 | December 16, 2031 | Drug product | U-4389 | 218316 |
| 11033499 | June 19, 2033 | Drug product | U-4496 | 218316 |
| 9764003 | June 21, 2033 | Method of use | U-3161 | 215256 |
| 12239739 | May 2, 2034 | Method of use | U-4388 | 218316 |
| 10278923 | May 2, 2034 | Method of use | U-4389 | 218316 |
| 12569543 | April 28, 2037 | Method of use | U-4443 | 215256 |
| 12214017 | August 24, 2038 | Drug product | U-3162 | 215256 |
| 11752198 | August 24, 2038 | Drug product | U-3162 | 215256 |
| 10888605 | August 24, 2038 | Drug product | U-3162 | 215256 |
| 12551536 | October 10, 2038 | Method of use | U-4418 | 215256 |
| 12029779 | October 10, 2038 | Method of use | U-3162 | 215256 |
| 12396953 | February 1, 2039 | Drug product | U-4387 | 218316 |
| 11833248 | February 1, 2039 | Drug product | U-4387 | 218316 |
| 11478533 | May 13, 2040 | Method of use | U-3861 | 215256 |
| 11318191 | February 17, 2041 | Drug product | U-3162 | 215256 |
| 11318191 | February 17, 2041 | Drug product | U-4443 | 215256 |
| 11318191 | February 17, 2041 | Drug product | U-4560 | 215256 |
Wegovy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-190 | New dosing schedule | July 21, 2026 | 215256 |
| I-935 | New indication | March 8, 2027 | 215256 |
| I-973 | New indication | August 15, 2028 | 215256 |
| NP | New product | December 22, 2028 | 218316 |
Wegovy NDC codes
Questions
Is there a generic for Wegovy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Wegovy (semaglutide). The Orange Book shows its last listed patent expires February 17, 2041 and its last listed exclusivity ends December 22, 2028.
What is the generic name for Wegovy?
The active ingredient in Wegovy is semaglutide, per the FDA Orange Book.
When does the Wegovy patent expire?
The last patent listed for Wegovy 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 Wegovy and Semaglutide
- What is Wegovy used for?FDA label uses
- Is Wegovy a controlled substance?Federal schedule
- Generic for OzempicFDA 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
- Wegovy Medicare Part D coverageBy plan and state
- NDC 0169-4404Wegovy NDC record
- NDC 0169-4409Wegovy NDC record
- NDC 0169-4415Wegovy NDC record