paroxetine mesylate · Legacy · NDA 204516

Brisdelle

Earliest generic entry, as listed
6 Apr 2029

Blocked by patent: US 8658663.

Listed patents · 1 unexpired

PatentClaimsExpires
US 8658663drug substance, drug product, use U-904 · sets the listed date6 Apr 2029

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 · 1

NDA · productFormStrengthListed expiry
204516 · 001 · RLDcapsule, oralEQ 7.5MG BASE6 Apr 2029
Expired or delisted (2)
  • US 8946251 · substance, product, use U-904 · 4 Aug 2026
  • US 9393237 · use U-904 · 4 Aug 2026