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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
AstraZeneca
Argus Health
Johnson and Johnson
McKinsey
Healthtrust
Express Scripts
Fish and Richardson
Daiichi Sankyo

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020912

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NDA 020912 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 three 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 020912
Tradename:AGGRASTAT
Applicant:Medicure
Ingredient:tirofiban hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 020912
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 020912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912 NDA Medicure International Inc 25208-001 N 25208-001-04
AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912 NDA Medicure International Inc 25208-001 N 25208-001-04

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)
Approval Date:May 14, 1998TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Jan 29, 2019Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:May 1, 2023Product 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:RXDosage:SOLUTION;INJECTIONStrengthEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)
Approval Date:Aug 31, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 29, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF INHIBITING PLATELET AGGREGATION WITH AGGRASTAT (TIROFIBAN HYDROCHLORIDE)

Expired US Patents for NDA 020912

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 ➤ Sign Up ➤ Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 ➤ Sign Up ➤ Sign Up
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 ➤ Sign Up ➤ Sign Up
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
Express Scripts
UBS
QuintilesIMS
Colorcon
Farmers Insurance
Deloitte
Daiichi Sankyo

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