amlodipine besylate; celecoxib · Purple Biotech · NDA 210045

Consensi

Earliest generic entry, as listed · earliest of 3 marketed strengths
14 Jun 2038

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 10350171.

Listed patents · 1 unexpired

PatentClaimsExpires
US 10350171drug product · sets the listed date14 Jun 2038

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 · 3

NDA · productFormStrengthListed expiry
210045 · 001 · RLD · discontinuedtablet, oralEQ 2.5MG BASE;200MG14 Jun 2038
210045 · 002 · RLD · discontinuedtablet, oralEQ 5MG BASE;200MG14 Jun 2038
210045 · 003 · RLD · discontinuedtablet, oralEQ 10MG BASE;200MG14 Jun 2038