Is there a generic for Tirofiban hydrochloride?

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

What is the reference-listed drug for Tirofiban hydrochloride?

AGGRASTAT (NDA 020912, MEDICURE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tirofiban hydrochloride are approved?

Tirofiban hydrochloride is approved in the following dosage forms: injectable, solution.

FDA Orange Book · active-ingredient family

Tirofiban hydrochloride

Tirofiban hydrochloride is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AGGRASTAT · NDA 020912

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, solution

Product	Applicant	Application	TE	Approved
AGGRASTATRLD×2	MEDICURE	NDA 020912	—	Aug 31, 2016
AGGRASTATRLD×3	MEDICURE	NDA 020913	AP	May 17, 2002

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
TIROFIBAN HYDROCHLORIDE×2	EUGIA PHARMA	ANDA 216379	AP	May 01, 2023
TIROFIBAN HYDROCHLORIDE×2	NEXUS	ANDA 213947	AP	Feb 07, 2023
TIROFIBAN HYDROCHLORIDE	GLAND	ANDA 206888	AP	Apr 08, 2021

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.

Tirofiban hydrochloride — frequently asked questions

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

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