pemetrexed dipotassium · Avyxa Holdings · NDA 210661

Axtle

Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Jun 2045

Blocked by patent: US 12721811.

Listed patents · 1 unexpired

PatentClaimsExpires
US 12721811product25 Jun 2045

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 · 2

NDA · productFormStrengthListed expiry
210661 · 001 · RLDpowder, intravenousEQ 100MG BASE/VIAL25 Jun 2045
210661 · 002 · RLDpowder, intravenousEQ 500MG BASE/VIAL25 Jun 2045