methotrexate · Cosette · NDA 204824
Otrexup Pfs
Earliest generic entry, as listed · earliest of 6 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204824 · 009 · RLD · discontinued | solution, subcutaneous | 10MG/0.4ML (10MG/0.4ML) | open |
| 204824 · 010 · RLD · discontinued | solution, subcutaneous | 15MG/0.6ML (15MG/0.6ML) | open |
| 204824 · 011 · RLD · discontinued | solution, subcutaneous | 17.5MG/0.7ML (17.5MG/0.7ML) | open |
| 204824 · 012 · RLD · discontinued | solution, subcutaneous | 20MG/0.8ML (20MG/0.8ML) | open |
| 204824 · 013 · RLD · discontinued | solution, subcutaneous | 22.5MG/0.9ML (22.5MG/0.9ML) | open |
| 204824 · 014 · RLD · discontinued | solution, subcutaneous | 25MG/ML (25MG/ML) | open |