Is there a generic for Tolcapone?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Tolcapone, referencing the brand TASMAR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tolcapone?

TASMAR (NDA 020697, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tolcapone are approved?

Tolcapone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Tolcapone

Tolcapone is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TASMAR · NDA 020697

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TASMARRLD×2	BAUSCH	NDA 020697	—	Jan 29, 1998

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
TOLCAPONE	ALVOGEN	ANDA 207729	—	Jul 29, 2020
TOLCAPONE	DR REDDYS LABS SA	ANDA 210095	—	Aug 01, 2019
TOLCAPONE	INGENUS PHARMS LLC	ANDA 208937	—	Aug 07, 2018
TOLCAPONE	PH HEALTH	ANDA 204584	—	Mar 26, 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.

Tolcapone — frequently asked questions

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

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