argatroban · Plano Pharms · NDA 022434, 022485, 209552, 212035
Argatroban In Sodium Chloride
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7589106 | drug product, use U-1163 | 26 Sep 2027 |
| US 7687516 | drug product, use U-1164 | 26 Sep 2027 |
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
- Enters 12-month window basis: patent · 022434-001Listed date 26 Sep 2027Detected 24 Oct 2026
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022434 · 001 · RLD · discontinued | injectable, intravenous | 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Sep 2027 |
| 022485 · 001 · RLD | injectable, intravenous | 125MG/125ML (1MG/ML) | open |
| 209552 · 001 | solution, intravenous | 50MG/50ML (1MG/ML) | open |
| 212035 · 001 · RLD | solution, intravenous | 50MG/50ML (1MG/ML) | open |