Orange Book product · Brand (NDA)

EDARBYCLOR

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Brand (NDA)NDA 202331TE ABRX AZURITY

Dec 20, 2011

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 20, 2011
14 yr 9 mo ago
Today
Patent 9066936 expires
Listed drug product patent expiration.
Mar 26, 2028
in 1 yr 10 mo
Patent 9169238 expires
Listed drug product patent expiration.
Feb 04, 2030
in 3 yr 8 mo
Patent 9387249 expires
Listed method-of-use patent (U-3) expiration.
Jul 01, 2031
in 5 yr 1 mo

Active ingredient

AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE

Strength

EQ 40MG MEDOXOMIL;12.5MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 202331

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9066936	Mar 26, 2028	in 1 yr 10 mo	Product
9169238	Feb 04, 2030	in 3 yr 8 mo	Product
9387249	Jul 01, 2031	in 5 yr 1 mo	U-3