vimseltinib · Deciphera Pharms · NDA 219304

Romvimza

Earliest generic entry, as listed · earliest of 3 marketed strengths
30 Apr 2045

Blocked by patent: US 12509443, US 12686672.

Listed patents · 13 unexpired

PatentClaimsExpires
US 12509443product30 Apr 2045
US 12686672product30 Apr 2045
US 12447149product6 Dec 2044
US 12528787substance, product6 Dec 2044
US 12551483product6 Dec 2044
US 12617775substance, product6 Dec 2044
US 12643883substance, product6 Dec 2044
US 11103507use U-41453 Feb 2040
US 11679110use U-41453 Feb 2040
US 12285430use U-414523 Dec 2039
US 12485120use U-414523 Dec 2039
US 12582655use U-414523 Dec 2039
US 9181223substance, product14 Mar 2034

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)14 Feb 2030

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 · 3

NDA · productFormStrengthListed expiry
219304 · 001 · RLDcapsule, oral14MG30 Apr 2045
219304 · 002 · RLDcapsule, oral20MG30 Apr 2045
219304 · 003 · RLDcapsule, oral30MG30 Apr 2045