cliffwatch

amlodipine benzoate · Azurity · NDA 211340

Katerzia

Earliest generic entry, as listed
11 Apr 2039

Blocked by patent: US 10799453.

Listed patents · 14 unexpired

19 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 10799453drug product · sets the listed date11 Apr 2039
US 10695329drug product16 Oct 2037
US 10894039use U-185, U-36 Oct 2037
US 10894039 listing rowuse U-1856 Oct 2037
US 10894039 listing rowuse U-36 Oct 2037
US 10952998drug product6 Oct 2037
US 10959991use U-158, U-396 Oct 2037
US 10959991 listing rowuse U-1586 Oct 2037
US 10959991 listing rowuse U-396 Oct 2037
US 11364230drug product6 Oct 2037
US 11471409use U-3447, U-34486 Oct 2037
US 11471409 listing rowuse U-34476 Oct 2037
US 11471409 listing rowuse U-34486 Oct 2037
US 11484498drug product6 Oct 2037
US 11701326drug product6 Oct 2037
US 11918685use U-3447, U-34486 Oct 2037
US 11918685 listing rowuse U-34476 Oct 2037
US 11918685 listing rowuse U-34486 Oct 2037
US 12053461drug product6 Oct 2037
US 12336984use U-3447, U-34486 Oct 2037
US 12336984 listing rowuse U-34476 Oct 2037
US 12336984 listing rowuse U-34486 Oct 2037
US 12383498drug product6 Oct 2037
US 12721843drug product6 Oct 2037

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
211340 · 001 · RLDsuspension, oralEQ 1MG BASE/ML11 Apr 2039