amlodipine besylate; indapamide; telmisartan · Azurity · NDA 219423

Widaplik

Earliest generic entry, as listed · earliest of 3 marketed strengths
23 Jan 2038

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

Blocked by patent: US 10322117, US 10799487, US 12465599, US 12673047.

Listed patents · 4 unexpired

PatentClaimsExpires
US 10322117drug product · sets the listed date23 Jan 2038
US 10799487drug product, use U-3448 · sets the listed date23 Jan 2038
US 12465599drug product · sets the listed date23 Jan 2038
US 12673047drug product · sets the listed date23 Jan 2038

Exclusivities · 1 unexpired

NPnew product5 Jun 2028

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
219423 · 001 · RLD · discontinuedtablet, oralEQ 1.25MG BASE;0.625MG;10MG23 Jan 2038
219423 · 002 · RLD · discontinuedtablet, oralEQ 2.5MG BASE;1.25MG;20MG23 Jan 2038
219423 · 003 · RLD · discontinuedtablet, oralEQ 5MG BASE;2.5MG;40MG23 Jan 2038