FDA Orange Book
Is there a generic for Zepbound (autoinjector)?
Zepbound (autoinjector) contains tirzepatide. 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 Zepbound (autoinjector) (tirzepatide). The Orange Book shows its last listed patent expires July 22, 2039 and its last listed exclusivity ends December 20, 2027.
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Zepbound (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 10MG/0.5ML (10MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 12.5MG/0.5ML (12.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 15MG/0.5ML (15MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 2.5MG/0.5ML (2.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 7.5MG/0.5ML (7.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 217806, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zepbound (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9474780 | May 13, 2036 | Drug substance, Drug product | None | 217806 |
| 11918623 | June 14, 2039 | Method of use | U-3855 | 217806 |
| 12629404 | June 14, 2039 | Drug product | U-4531 | 217806 |
| 12629404 | June 14, 2039 | Drug product | U-4532 | 217806 |
| 11357820 | June 14, 2039 | Drug product | None | 217806 |
| 12453756 | June 14, 2039 | Drug product | None | 217806 |
| 12343382 | July 22, 2039 | Method of use | U-4228 | 217806 |
| 12343382 | July 22, 2039 | Method of use | U-4227 | 217806 |
| 12343382 | July 22, 2039 | Method of use | U-4409 | 217806 |
| 12343382 | July 22, 2039 | Method of use | U-4410 | 217806 |
| 12453758 | July 22, 2039 | Method of use | U-4308 | 217806 |
| 12453758 | July 22, 2039 | Method of use | U-4311 | 217806 |
| 12453758 | July 22, 2039 | Method of use | U-4310 | 217806 |
| 12453758 | July 22, 2039 | Method of use | U-4309 | 217806 |
| 12616740 | July 22, 2039 | Method of use | U-4497 | 217806 |
| 12616740 | July 22, 2039 | Method of use | U-4498 | 217806 |
| 12616740 | July 22, 2039 | Method of use | U-4499 | 217806 |
Zepbound (autoinjector) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | November 8, 2026 | 217806 |
| NCE | New chemical entity | May 13, 2027 | 217806 |
| M-82 | Miscellaneous | October 18, 2027 | 217806 |
| I-958 | New indication | December 20, 2027 | 217806 |
Zepbound (autoinjector) NDC codes
Questions
Is there a generic for Zepbound (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zepbound (autoinjector) (tirzepatide). The Orange Book shows its last listed patent expires July 22, 2039 and its last listed exclusivity ends December 20, 2027.
What is the generic name for Zepbound (autoinjector)?
The active ingredient in Zepbound (autoinjector) is tirzepatide, per the FDA Orange Book.
When does the Zepbound (autoinjector) patent expire?
The last patent listed for Zepbound (autoinjector) in the Orange Book expires July 22, 2039. 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.