edaravone · Shionogi · NDA 209176

Radicava

Earliest generic entry, as listed · earliest of 2 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

  • Generic approved · ANDA 218349, Zydus Pharms · 209176-001Approved 22 Jul 2026Detected 25 Oct 2026Historical import

Products covered · 2

NDA · productFormStrengthListed expiry
209176 · 001 · RLD · discontinuedsolution, intravenous30MG/100ML (0.3MG/ML)open
209176 · 002 · RLD · discontinuedsolution, intravenous60MG/100ML (0.6MG/ML)open