gadoversetamide · Liebel-Flarsheim · NDA 020937, 020975
Optimark
Earliest generic entry, as listed · earliest of 5 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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020937 · 001 · RLD · discontinued | injectable, injection | 1654.5MG/5ML (330.9MG/ML) | open |
| 020937 · 002 · RLD · discontinued | injectable, injection | 3309MG/10ML (330.9MG/ML) | open |
| 020937 · 003 · RLD · discontinued | injectable, injection | 4963.5MG/15ML (330.9MG/ML) | open |
| 020937 · 004 · RLD · discontinued | injectable, injection | 6618MG/20ML (330.9MG/ML) | open |
| 020975 · 001 · RLD · discontinued | injectable, injection | 16.545GM/50ML (330.9MG/ML) | open |