rasagiline mesylate · Teva · NDA 021641

Azilect

Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Aug 2027

Blocked by patent: US 7815942.

Listed patents · 2 unexpired

PatentClaimsExpires
US 7815942drug substance, drug product, use U-219 · sets the listed date27 Aug 2027
US 7572834drug product5 Dec 2026

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

  • Enters 12-month window basis: patent · 021641-002Listed date 27 Aug 2027Detected 24 Oct 2026
  • Enters 12-month window basis: patent · 021641-001Listed date 27 Aug 2027Detected 24 Oct 2026

Products covered · 2

NDA · productFormStrengthListed expiry
021641 · 001 · RLDtablet, oralEQ 0.5MG BASE27 Aug 2027
021641 · 002 · RLDtablet, oralEQ 1MG BASE27 Aug 2027