Is there a generic for Amlodipine besylate; telmisartan?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Amlodipine besylate; telmisartan, referencing the brand TWYNSTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amlodipine besylate; telmisartan?

TWYNSTA (NDA 022401, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amlodipine besylate; telmisartan are approved?

Amlodipine besylate; telmisartan is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Amlodipine besylate; telmisartan

Amlodipine besylate; telmisartan is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TWYNSTA · NDA 022401

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TWYNSTARLD×4	BOEHRINGER INGELHEIM	NDA 022401	—	Oct 16, 2009

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
TELMISARTAN AND AMLODIPINE×4	ALEMBIC	ANDA 205234	—	Nov 17, 2016
TELMISARTAN AND AMLODIPINE×4	MYLAN	ANDA 202516	—	Aug 26, 2014
TELMISARTAN AND AMLODIPINE×4	LUPIN	ANDA 201586	—	Jan 08, 2014
TELMISARTAN AND AMLODIPINE×4	TORRENT	ANDA 202517	—	Jan 08, 2014

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Amlodipine besylate; telmisartan — frequently asked questions

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

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