FDA Orange Book
Is there a generic for Mounjaro?
Mounjaro 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 Mounjaro (tirzepatide). The Orange Book shows its last listed patent expires December 30, 2041 and its last listed exclusivity ends December 19, 2028.
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Mounjaro 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 | 10MG/2.4ML (4.17MG/ML) | 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 | 20MG/2.4ML (8.33MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 30MG/2.4ML (12.5MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 40MG/2.4ML (16.7MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 50MG/2.4ML (20.8MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 60MG/2.4ML (25MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 7.5MG/0.5ML (7.5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 215866, 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.
Mounjaro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9474780 | May 13, 2036 | Drug substance, Drug product | U-4374 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4386 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4380 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4383 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4378 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4375 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4385 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4384 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4376 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4382 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4379 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4381 | 215866 |
| 12453755 | June 14, 2039 | Method of use | U-4377 | 215866 |
| 12629404 | June 14, 2039 | Drug product | U-4533 | 215866 |
| 12629404 | June 14, 2039 | Drug product | U-4534 | 215866 |
| 11357820 | June 14, 2039 | Drug substance, Drug product | None | 215866 |
| 12453756 | June 14, 2039 | Drug product | None | 215866 |
| 12343382 | July 22, 2039 | Method of use | U-4229 | 215866 |
| 12343382 | July 22, 2039 | Method of use | U-4230 | 215866 |
| 12343382 | July 22, 2039 | Method of use | U-4231 | 215866 |
| 12343382 | July 22, 2039 | Method of use | U-4232 | 215866 |
| 12343382 | July 22, 2039 | Method of use | U-4401 | 215866 |
| 12343382 | July 22, 2039 | Method of use | U-4400 | 215866 |
| 12616740 | July 22, 2039 | Method of use | U-4500 | 215866 |
| 12616740 | July 22, 2039 | Method of use | U-4501 | 215866 |
| 12616740 | July 22, 2039 | Method of use | U-4502 | 215866 |
| 12295987 | December 30, 2041 | Method of use | U-4193 | 215866 |
| 12295987 | December 30, 2041 | Method of use | U-4192 | 215866 |
Mounjaro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 13, 2027 | 215866 |
| NPP | New patient population | December 19, 2028 | 215866 |
Mounjaro NDC codes
Questions
Is there a generic for Mounjaro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mounjaro (tirzepatide). The Orange Book shows its last listed patent expires December 30, 2041 and its last listed exclusivity ends December 19, 2028.
What is the generic name for Mounjaro?
The active ingredient in Mounjaro is tirzepatide, per the FDA Orange Book.
When does the Mounjaro patent expire?
The last patent listed for Mounjaro in the Orange Book expires December 30, 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 Mounjaro and Tirzepatide
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- Is Mounjaro a controlled substance?Federal schedule
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- Glucose-dependent Insulinotropic Polypeptide Receptor Agonists listFDA drug class
- Mounjaro Medicare Part D coverageBy plan and state
- NDC 0002-1152Mounjaro NDC record
- NDC 0002-1243Mounjaro NDC record
- NDC 0002-1457Mounjaro NDC record