methotrexate · Cosette · NDA 204824
Otrexup
Earliest generic entry, as listed · earliest of 8 marketed strengths
27 May 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8814834.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8814834 | product | 27 May 2031 |
| US 11497753 | product | 19 Mar 2030 |
| US 12357642 | product | 19 Mar 2030 |
| US 8480631 | product, use U-1442 | 19 Mar 2030 |
| US 8579865 | product, use U-1442 | 19 Mar 2030 |
| US 8945063 | product, use U-1442 | 19 Mar 2030 |
| US 9421333 | product, use U-1442 | 19 Mar 2030 |
| US 10709844 | product | 10 Mar 2029 |
| US 11684723 | product | 10 Mar 2029 |
| US 9867949 | product | 10 Mar 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204824 · 001 · RLD · discontinued | solution, subcutaneous | 10MG/0.4ML (10MG/0.4ML) | 27 May 2031 |
| 204824 · 002 · RLD · discontinued | solution, subcutaneous | 15MG/0.4ML (15MG/0.4ML) | 27 May 2031 |
| 204824 · 003 · RLD · discontinued | solution, subcutaneous | 20MG/0.4ML (20MG/0.4ML) | 27 May 2031 |
| 204824 · 004 · RLD · discontinued | solution, subcutaneous | 25MG/0.4ML (25MG/0.4ML) | 27 May 2031 |
| 204824 · 005 · RLD · discontinued | solution, subcutaneous | 7.5MG/0.4ML (7.5MG/0.4ML) | 27 May 2031 |
| 204824 · 006 · RLD · discontinued | solution, subcutaneous | 12.5MG/0.4ML (12.5MG/0.4ML) | 27 May 2031 |
| 204824 · 007 · RLD · discontinued | solution, subcutaneous | 17.5MG/0.4ML (17.5MG/0.4ML) | 27 May 2031 |
| 204824 · 008 · RLD · discontinued | solution, subcutaneous | 22.5MG/0.4ML (22.5MG/0.4ML) | 27 May 2031 |
Expired or delisted (5)
- US 8021335 · product · 4 Oct 2026
- US 11446441 · product · 24 Jan 2026
- US 8562564 · product · 24 Jan 2026
- US 9533102 · product · 24 Jan 2026
- US 9629959 · product · 24 Jan 2026