methotrexate · Medexus · NDA 205776
Rasuvo
Earliest generic entry, as listed · earliest of 9 marketed strengths
1 Jun 2029
Blocked by patent: US 8664231. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8664231 | use U-1442 | 1 Jun 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 · 10
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205776 · 001 · RLD | solution, subcutaneous | 7.5MG/0.15ML (7.5MG/0.15ML) | 1 Jun 2029 |
| 205776 · 002 · RLD | solution, subcutaneous | 10MG/0.20ML (10MG/0.20ML) | 1 Jun 2029 |
| 205776 · 003 · RLD | solution, subcutaneous | 12.5MG/0.25ML (12.5MG/0.25ML) | 1 Jun 2029 |
| 205776 · 004 · RLD | solution, subcutaneous | 15MG/0.30ML (15MG/0.30ML) | 1 Jun 2029 |
| 205776 · 005 · RLD | solution, subcutaneous | 17.5MG/0.35ML (17.5MG/0.35ML) | 1 Jun 2029 |
| 205776 · 006 · RLD | solution, subcutaneous | 20MG/0.4ML (20MG/0.4ML) | 1 Jun 2029 |
| 205776 · 007 · RLD | solution, subcutaneous | 22.5MG/0.45ML (22.5MG/0.45ML) | 1 Jun 2029 |
| 205776 · 008 · RLD | solution, subcutaneous | 25MG/0.5ML (25MG/0.5ML) | 1 Jun 2029 |
| 205776 · 009 · RLD · discontinued | solution, subcutaneous | 27.5MG/0.55ML (27.5MG/0.55ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1 Jun 2029 |
| 205776 · 010 · RLD | solution, subcutaneous | 30MG/0.6ML (30MG/0.6ML) | 1 Jun 2029 |