tirzepatide · Eli Lilly And Co · NDA 215866
Mounjaro Kwikpen
Earliest generic entry, as listed · earliest of 6 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 · 4 unexpired
12 Orange Book listing rows for 4 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 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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215866 · 019 · RLD | solution, subcutaneous | 10MG/2.4ML (4.17MG/ML) | 30 Dec 2041 |
| 215866 · 020 · RLD | solution, subcutaneous | 20MG/2.4ML (8.33MG/ML) | 30 Dec 2041 |
| 215866 · 021 · RLD | solution, subcutaneous | 30MG/2.4ML (12.5MG/ML) | 30 Dec 2041 |
| 215866 · 022 · RLD | solution, subcutaneous | 40MG/2.4ML (16.7MG/ML) | 30 Dec 2041 |
| 215866 · 023 · RLD | solution, subcutaneous | 50MG/2.4ML (20.8MG/ML) | 30 Dec 2041 |
| 215866 · 024 · RLD | solution, subcutaneous | 60MG/2.4ML (25MG/ML) | 30 Dec 2041 |