Is there a generic for Methscopolamine bromide?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Methscopolamine bromide, referencing the brand PAMINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methscopolamine bromide?

PAMINE (NDA 008848, FOUGERA PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methscopolamine bromide are approved?

Methscopolamine bromide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Methscopolamine bromide

Methscopolamine bromide is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PAMINE · NDA 008848

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PAMINE×2	FOUGERA PHARMS	NDA 008848	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
METHSCOPOLAMINE BROMIDE×2	NE RX PHARMA	ANDA 216786	AA	Feb 01, 2024
METHSCOPOLAMINE BROMIDE×2	UNICHEM	ANDA 200602	AA	Sep 24, 2012
METHSCOPOLAMINE BROMIDE×2	BRECKENRIDGE PHARM	ANDA 040642	AA	Dec 06, 2011
METHSCOPOLAMINE BROMIDE×2	CHARTWELL RX	ANDA 040624	—	Dec 28, 2006
METHSCOPOLAMINE BROMIDE	PVT FORM	ANDA 080970	—	Approved Prior to Jan 1, 1982

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.

Methscopolamine bromide — frequently asked questions

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

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