tirzepatide · Eli Lilly And Co · NDA 215866
Mounjaro
Earliest generic entry, as listed · earliest of 12 marketed strengths
30 Dec 2041
Blocked by patent: US 12295987. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
28 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12295987 | use U-4192, U-4193 | 30 Dec 2041 |
| US 12295987 listing row | use U-4192 · sets the listed date | 30 Dec 2041 |
| US 12295987 listing row | use U-4193 · sets the listed date | 30 Dec 2041 |
| US 12343382 | use U-4229, U-4230, U-4231, U-4232, U-4400, U-4401 | 22 Jul 2039 |
| US 12343382 listing row | use U-4229 | 22 Jul 2039 |
| US 12343382 listing row | use U-4230 | 22 Jul 2039 |
| US 12343382 listing row | use U-4231 | 22 Jul 2039 |
| US 12343382 listing row | use U-4232 | 22 Jul 2039 |
| US 12343382 listing row | use U-4400 | 22 Jul 2039 |
| US 12343382 listing row | use U-4401 | 22 Jul 2039 |
| US 12616740 | use U-4500, U-4501, U-4502 | 22 Jul 2039 |
| US 12616740 listing row | use U-4500 | 22 Jul 2039 |
| US 12616740 listing row | use U-4501 | 22 Jul 2039 |
| US 12616740 listing row | use U-4502 | 22 Jul 2039 |
| US 11357820 | drug substance, drug product | 14 Jun 2039 |
| US 12453755 | use U-4375, U-4376, U-4377, U-4378, U-4379, U-4380, U-4381, U-4382, U-4383, U-4384, U-4385, U-4386 | 14 Jun 2039 |
| US 12453755 listing row | use U-4375 | 14 Jun 2039 |
| US 12453755 listing row | use U-4376 | 14 Jun 2039 |
| US 12453755 listing row | use U-4377 | 14 Jun 2039 |
| US 12453755 listing row | use U-4378 | 14 Jun 2039 |
| US 12453755 listing row | use U-4379 | 14 Jun 2039 |
| US 12453755 listing row | use U-4380 | 14 Jun 2039 |
| US 12453755 listing row | use U-4381 | 14 Jun 2039 |
| US 12453755 listing row | use U-4382 | 14 Jun 2039 |
| US 12453755 listing row | use U-4383 | 14 Jun 2039 |
| US 12453755 listing row | use U-4384 | 14 Jun 2039 |
| US 12453755 listing row | use U-4385 | 14 Jun 2039 |
| US 12453755 listing row | use U-4386 | 14 Jun 2039 |
| US 12453756 | drug product | 14 Jun 2039 |
| US 12629404 | drug product, use U-4533, U-4534 | 14 Jun 2039 |
| US 12629404 listing row | drug product, use U-4533 | 14 Jun 2039 |
| US 12629404 listing row | drug product, use U-4534 | 14 Jun 2039 |
| US 9474780 | drug substance, drug product, use U-4374 | 13 May 2036 |
Exclusivities · 2 unexpired
| NPP | new patient population | 19 Dec 2028 |
| NCE | new chemical entity (5 years) | 13 May 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 12
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215866 · 007 · RLD | solution, subcutaneous | 2.5MG/0.5ML (2.5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 008 · RLD | solution, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 009 · RLD | solution, subcutaneous | 7.5MG/0.5ML (7.5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 010 · RLD | solution, subcutaneous | 10MG/0.5ML (10MG/0.5ML) | 30 Dec 2041 |
| 215866 · 011 · RLD | solution, subcutaneous | 12.5MG/0.5ML (12.5MG/0.5ML) | 30 Dec 2041 |
| 215866 · 012 · RLD | solution, subcutaneous | 15MG/0.5ML (15MG/0.5ML) | 30 Dec 2041 |
| 215866 · 013 · RLD | solution, subcutaneous | 10MG/2.4ML (4.17MG/ML) | 30 Dec 2041 |
| 215866 · 014 · RLD | solution, subcutaneous | 20MG/2.4ML (8.33MG/ML) | 30 Dec 2041 |
| 215866 · 015 · RLD | solution, subcutaneous | 30MG/2.4ML (12.5MG/ML) | 30 Dec 2041 |
| 215866 · 016 · RLD | solution, subcutaneous | 40MG/2.4ML (16.7MG/ML) | 30 Dec 2041 |
| 215866 · 017 · RLD | solution, subcutaneous | 50MG/2.4ML (20.8MG/ML) | 30 Dec 2041 |
| 215866 · 018 · RLD | solution, subcutaneous | 60MG/2.4ML (25MG/ML) | 30 Dec 2041 |