rilpivirine hydrochloride · Janssen Prods · NDA 219016

Edurant Ped

Earliest generic entry, as listed
23 Oct 2037

Blocked by patent: US 11065198.

Listed patents · 1 unexpired

PatentClaimsExpires
US 11065198product23 Oct 2037

Exclusivities · 2 unexpired

PEDpediatric (6 months added)15 Sep 2027
NPnew product15 Mar 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 · 1

NDA · productFormStrengthListed expiry
219016 · 001 · RLDtablet, for suspension, oralEQ 2.5MG BASE23 Oct 2037