Is there a generic for Pergolide mesylate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Pergolide mesylate, referencing the brand PERMAX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Pergolide mesylate?

PERMAX (NDA 019385, VALEANT PHARM INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pergolide mesylate are approved?

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

FDA Orange Book · active-ingredient family

Pergolide mesylate

Pergolide mesylate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PERMAX · NDA 019385

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PERMAX×3	VALEANT PHARM INTL	NDA 019385	—	Dec 30, 1988

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
PERGOLIDE MESYLATE×3	IVAX SUB TEVA PHARMS	ANDA 076094	—	Sep 04, 2003
PERGOLIDE MESYLATE×3	STRIDES PHARMA	ANDA 076061	—	Nov 27, 2002

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.

Pergolide mesylate — frequently asked questions

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

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