vandetanib · Genzyme Corp · NDA 022405

Caprelsa

Earliest generic entry, as listed · earliest of 2 marketed strengths
8 Aug 2028

Blocked by patent: US 8067427.

Listed patents · 1 unexpired

PatentClaimsExpires
US 8067427drug product · sets the listed date8 Aug 2028

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 · 2

NDA · productFormStrengthListed expiry
022405 · 001 · RLDtablet, oral100MG8 Aug 2028
022405 · 002 · RLDtablet, oral300MG8 Aug 2028