esomeprazole magnesium · Dexcel · NDA 214278

Esomeprazole Magnesium

Earliest generic entry, as listed
8 Dec 2036

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

Blocked by patent: US 10076494, US 10835488.

Listed patents · 2 unexpired

PatentClaimsExpires
US 10076494drug product · sets the listed date8 Dec 2036
US 10835488drug product · sets the listed date8 Dec 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 · 1

NDA · productFormStrengthListed expiry
214278 · 001 · RLD · discontinuedtablet, orally disintegrating, delayed release, oralEQ 20MG BASE8 Dec 2036