Is there a generic for Almotriptan malate?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Almotriptan malate, referencing the brand AXERT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Almotriptan malate?

AXERT (NDA 021001, JANSSEN PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Almotriptan malate are approved?

Almotriptan malate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Almotriptan malate

Almotriptan malate is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AXERT · NDA 021001

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
AXERTRLD×2	JANSSEN PHARMS	NDA 021001	—	May 07, 2001

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
ALMOTRIPTAN MALATE×2	AJANTA PHARMA LTD	ANDA 205523	AB	Mar 03, 2016
ALMOTRIPTAN MALATE×2	MYLAN	ANDA 205171	AB	Nov 09, 2015
ALMOTRIPTAN MALATE×2	TEVA PHARMS USA	ANDA 078027	AB	Jul 07, 2015

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.

Almotriptan malate — frequently asked questions

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

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