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Details for New Drug Application (NDA): 020913

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NDA 020913 describes AGGRASTAT, which is a drug marketed by Medicure and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the AGGRASTAT profile page.

The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.

Summary for 020913

Tradename:	AGGRASTAT
Applicant:	Medicure
Ingredient:	tirofiban hydrochloride
Patents:	2
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 020913

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 020913

Physiological Effect

Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 020913

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913	NDA	Medicure International Inc	25208-002	25208-002-02	1 CONTAINER in 1 CARTON (25208-002-02) > 250 mL in 1 CONTAINER
AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913	NDA	Medicure International Inc	25208-002	25208-002-03	1 VIAL, GLASS in 1 CARTON (25208-002-03) > 100 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
Approval Date:	May 14, 1998	TE:		RLD:	No
Patent:		Patent Expiration:	Jan 29, 2019	Product Flag?		Substance Flag?		Delist Request?
Patent:		Patent Expiration:	May 1, 2023	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Approval Date:	May 17, 2002	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jan 29, 2019	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 020913

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-003	Apr 20, 2000
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-003	Apr 20, 2000
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020913-002	May 17, 2002

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