tirzepatide · Eli Lilly And Co · NDA 217806
Zepbound (Autoinjector)
Earliest generic entry, as listed · earliest of 6 marketed strengths
22 Jul 2039
Blocked by patent: US 12343382, US 12453758, US 12616740. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
17 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 12343382 | use U-4227, U-4228, U-4409, U-4410 | 22 Jul 2039 |
| US 12343382 listing row | use U-4227 · sets the listed date | 22 Jul 2039 |
| US 12343382 listing row | use U-4228 · sets the listed date | 22 Jul 2039 |
| US 12343382 listing row | use U-4409 · sets the listed date | 22 Jul 2039 |
| US 12343382 listing row | use U-4410 · sets the listed date | 22 Jul 2039 |
| US 12453758 | use U-4308, U-4309, U-4310, U-4311 | 22 Jul 2039 |
| US 12453758 listing row | use U-4308 · sets the listed date | 22 Jul 2039 |
| US 12453758 listing row | use U-4309 · sets the listed date | 22 Jul 2039 |
| US 12453758 listing row | use U-4310 · sets the listed date | 22 Jul 2039 |
| US 12453758 listing row | use U-4311 · sets the listed date | 22 Jul 2039 |
| US 12616740 | use U-4497, U-4498, U-4499 | 22 Jul 2039 |
| US 12616740 listing row | use U-4497 · sets the listed date | 22 Jul 2039 |
| US 12616740 listing row | use U-4498 · sets the listed date | 22 Jul 2039 |
| US 12616740 listing row | use U-4499 · sets the listed date | 22 Jul 2039 |
| US 11357820 | drug product | 14 Jun 2039 |
| US 11918623 | use U-3855 | 14 Jun 2039 |
| US 12453756 | drug product | 14 Jun 2039 |
| US 12629404 | drug product, use U-4531, U-4532 | 14 Jun 2039 |
| US 12629404 listing row | drug product, use U-4531 | 14 Jun 2039 |
| US 12629404 listing row | drug product, use U-4532 | 14 Jun 2039 |
| US 9474780 | drug substance, drug product | 13 May 2036 |
Exclusivities · 4 unexpired
| I-958 | new indication (3 years) | 20 Dec 2027 |
| M-82 | miscellaneous (3 years) | 18 Oct 2027 |
| NCE | new chemical entity (5 years) | 13 May 2027 |
| NP | new product | 8 Nov 2026 |
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
- Exclusivity expires within 90 days NP · 217806-006Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days NP · 217806-005Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days NP · 217806-004Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days NP · 217806-003Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days NP · 217806-002Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days NP · 217806-001Exclusivity expires 8 Nov 2026Detected 24 Oct 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217806 · 001 · RLD | solution, subcutaneous | 2.5MG/0.5ML (2.5MG/0.5ML) | 22 Jul 2039 |
| 217806 · 002 · RLD | solution, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | 22 Jul 2039 |
| 217806 · 003 · RLD | solution, subcutaneous | 7.5MG/0.5ML (7.5MG/0.5ML) | 22 Jul 2039 |
| 217806 · 004 · RLD | solution, subcutaneous | 10MG/0.5ML (10MG/0.5ML) | 22 Jul 2039 |
| 217806 · 005 · RLD | solution, subcutaneous | 12.5MG/0.5ML (12.5MG/0.5ML) | 22 Jul 2039 |
| 217806 · 006 · RLD | solution, subcutaneous | 15MG/0.5ML (15MG/0.5ML) | 22 Jul 2039 |