Is there a generic for Eprosartan mesylate?

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

What is the reference-listed drug for Eprosartan mesylate?

TEVETEN (NDA 020738, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Eprosartan mesylate are approved?

Eprosartan mesylate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Eprosartan mesylate

Eprosartan mesylate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TEVETEN · NDA 020738

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TEVETENRLD×3	ABBVIE	NDA 020738	—	Dec 22, 1997

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
EPROSARTAN MESYLATE×2	PHARMOBEDIENT	ANDA 202012	—	Nov 16, 2011

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.

Eprosartan mesylate — frequently asked questions

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

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