cyclophosphamide · Avyxa Holdings · NDA 210852

Frindovyx

Earliest generic entry, as listed · earliest of 3 marketed strengths
1 Dec 2035

Blocked by patent: US 11382923.

Listed patents · 2 unexpired

PatentClaimsExpires
US 11382923product1 Dec 2035
US 10849916product13 Jul 2035

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 · 3

NDA · productFormStrengthListed expiry
210852 · 001 · RLDsolution, intravenous500MG/ML (500MG/ML)1 Dec 2035
210852 · 002 · RLDsolution, intravenous1GM/2ML (500MG/ML)1 Dec 2035
210852 · 003 · RLDsolution, intravenous2GM/4ML (500MG/ML)1 Dec 2035