Is there a generic for Azilsartan kamedoxomil; chlorthalidone?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Azilsartan kamedoxomil; chlorthalidone, referencing the brand EDARBYCLOR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Azilsartan kamedoxomil; chlorthalidone?

EDARBYCLOR (NDA 202331, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Azilsartan kamedoxomil; chlorthalidone?

The Orange Book lists 3 patents against Azilsartan kamedoxomil; chlorthalidone products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Azilsartan kamedoxomil; chlorthalidone are approved?

Azilsartan kamedoxomil; chlorthalidone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Azilsartan kamedoxomil; chlorthalidone

Azilsartan kamedoxomil; chlorthalidone: 1 brand, 1 generic; first approved Dec 20, 2011; generic available.

Generic available

Generic status & protection

Generic available — 1 ANDA application approved.

Earliest patent expiry Mar 26, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 26, 2028

in 1 yr 9 mo

Originator applications

Brand (NDA) products

EDARBYCLORRLD

AZURITYNDA 20233120112 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG MEDOXOMIL;12.5MG	TABLET	ORAL	Rx	AB
EQ 40MG MEDOXOMIL;25MG	TABLET	ORAL	Rx	AB

Abbreviated applications

Generic (ANDA) products (1)

AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

ALKEM LABS LTDANDA 21749020252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG MEDOXOMIL;12.5MG	TABLET	ORAL	Rx	AB
EQ 40MG MEDOXOMIL;25MG	TABLET	ORAL	Rx	AB

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

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 9 mo	Product
9169238	Feb 04, 2030	in 3 yr 7 mo	Product
9387249	Jul 01, 2031	in 5 yr 1 mo	U-3

FDA approval span

Approval history

First approval

Dec 20, 2011

14 yr 9 mo ago

Most recent approval

Jan 21, 2025

1 yr 6 mo ago

Approvals span 2011–2025 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Azilsartan kamedoxomil; chlorthalidone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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