amifampridine phosphate · Catalyst Pharms · NDA 208078

Firdapse

Earliest generic entry, as listed
25 Feb 2037

Blocked by patent: US 10626088.

Listed patents · 6 unexpired

PatentClaimsExpires
US 10626088drug product · sets the listed date25 Feb 2037
US 10793893use U-295626 May 2034
US 11060128use U-295629 Jun 2032
US 11268128use U-295629 Jun 2032
US 11274331use U-295629 Jun 2032
US 11274332use U-295629 Jun 2032

Exclusivities · 1 unexpired

ODE-553orphan drug (7 years)29 Sep 2029

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
208078 · 001 · RLDtablet, oralEQ 10MG BASE25 Feb 2037