Is there a generic for Protriptyline hydrochloride?

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

What is the reference-listed drug for Protriptyline hydrochloride?

VIVACTIL (NDA 016012, 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 Protriptyline hydrochloride are approved?

Protriptyline hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Protriptyline hydrochloride

Protriptyline hydrochloride 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:VIVACTIL · NDA 016012

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
VIVACTIL×2	TEVA WOMENS	NDA 016012	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
PROTRIPTYLINE HYDROCHLORIDE×2	EPIC PHARMA LLC	ANDA 202220	AB	Nov 19, 2012
PROTRIPTYLINE HYDROCHLORIDE×2	SIGMAPHARM LABS LLC	ANDA 090462	AB	May 03, 2010
PROTRIPTYLINE HYDROCHLORIDE×2	HIKMA	ANDA 078913	—	Sep 16, 2008
VIVACTIL	CHARTWELL RX	ANDA 073644	—	Aug 24, 1995
VIVACTIL	CHARTWELL RX	ANDA 073645	—	Aug 24, 1995

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.

Protriptyline hydrochloride — frequently asked questions

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

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