capmatinib hydrochloride · Novartis Pharm · NDA 213591

Tabrecta

Earliest generic entry, as listed · earliest of 2 marketed strengths
22 Jul 2035

Blocked by patent: US 10596178, US 12208101.

Listed patents · 7 unexpired

PatentClaimsExpires
US 10596178product22 Jul 2035
US 12208101product22 Jul 2035
US 7767675substance, product19 Nov 2032
US 8420645substance, product5 Jun 2031
US 8901123use U-281320 May 2029
US 12084449use U-281319 Nov 2027
US 8461330substance, product19 Nov 2027

Exclusivities · 1 unexpired

ODE-291orphan drug (7 years)6 May 2027

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
213591 · 001 · RLDtablet, oralEQ 150MG BASE22 Jul 2035
213591 · 002 · RLDtablet, oralEQ 200MG BASE22 Jul 2035