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Fish and Richardson
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Generated: September 18, 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 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 020912
Tradename:AGGRASTAT
Applicant:Medicure
Ingredient:tirofiban hydrochloride
Patents:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020912
Generic Entry Date for 020912*:
Constraining patent/regulatory exclusivity:
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: 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 25208-001-04 1 VIAL, GLASS in 1 CARTON (25208-001-04) > 15 mL in 1 VIAL, GLASS
AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912 NDA Medicure International Inc 25208-001 25208-001-04 1 VIAL, GLASS in 1 CARTON (25208-001-04) > 15 mL in 1 VIAL, GLASS

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:➤ Try a Free TrialPatent Expiration:Jan 29, 2019Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent 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 SOLUTION;INJECTION 020912-002 Aug 31, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cipla
Cantor Fitzgerald
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Baxter

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