Is there a generic for Trimipramine maleate?

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

What is the reference-listed drug for Trimipramine maleate?

SURMONTIL (NDA 016792, TEVA WOMENS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Trimipramine maleate are approved?

Trimipramine maleate is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Trimipramine maleate

Trimipramine maleate 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:SURMONTIL · NDA 016792

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
SURMONTILRLD×3	TEVA WOMENS	NDA 016792	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
TRIMIPRAMINE MALEATE×3	BRECKENRIDGE	ANDA 208127	AB	Apr 15, 2016
TRIMIPRAMINE MALEATE×3	ELITE LABS INC	ANDA 077361	AB	Aug 02, 2006
TRIMIPRAMINE MALEATE	USL PHARMA	ANDA 071283	—	Dec 08, 1987
TRIMIPRAMINE MALEATE	USL PHARMA	ANDA 071284	—	Dec 08, 1987
TRIMIPRAMINE MALEATE	USL PHARMA	ANDA 071285	—	Dec 08, 1987

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.

Trimipramine maleate — frequently asked questions

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

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