warfarin sodium · Bristol Myers Squibb · NDA 009218
Coumadin
Earliest generic entry, as listed · earliest of 9 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 · 12
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 009218 · 005 · RLD · discontinued | tablet, oral | 10MG | open |
| 009218 · 007 · RLD · discontinued | tablet, oral | 5MG | open |
| 009218 · 012 · discontinued | injectable, injection | 75MG/VIAL | open |
| 009218 · 013 · RLD · discontinued | tablet, oral | 2MG | open |
| 009218 · 016 · RLD · discontinued | tablet, oral | 7.5MG | open |
| 009218 · 018 · RLD · discontinued | tablet, oral | 2.5MG | open |
| 009218 · 020 · discontinued | injectable, injection | 50MG/VIAL | open |
| 009218 · 022 · RLD · discontinued | tablet, oral | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 009218 · 023 · RLD · discontinued | tablet, oral | 4MG | open |
| 009218 · 024 · discontinued | injectable, injection | 5MG/VIAL | open |
| 009218 · 025 · RLD · discontinued | tablet, oral | 3MG | open |
| 009218 · 026 · RLD · discontinued | tablet, oral | 6MG | open |