paliperidone palmitate · Janssen Pharms · NDA 207946

Invega Trinza

Earliest generic entry, as listed · earliest of 4 marketed strengths
5 Apr 2036

Blocked by patent: US 10143693, US 10143693. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 2 unexpired

PatentClaimsExpires
US 10143693use U-24575 Apr 2036
US 10143693use U-24585 Apr 2036

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 · 4

NDA · productFormStrengthListed expiry
207946 · 001 · RLDsuspension, extended release, intramuscular273MG/0.875ML (273MG/0.875ML)5 Apr 2036
207946 · 002 · RLDsuspension, extended release, intramuscular410MG/1.315ML (311.79MG/ML)5 Apr 2036
207946 · 003 · RLDsuspension, extended release, intramuscular546MG/1.75ML (312MG/ML)5 Apr 2036
207946 · 004 · RLDsuspension, extended release, intramuscular819MG/2.625ML (312MG/ML)5 Apr 2036