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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

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 and two Paragraph IV challenges. 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
Generic Entry Date for 020913*:
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: 020913
Physiological EffectDecreased 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
Paragraph IV (Patent) Challenges for 020913
Tradename Dosage Ingredient NDA Submissiondate
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2019-08-29
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2018-10-03

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
Approval Date:May 14, 1998TE:RLD:No
Patent:  Start TrialPatent Expiration:Jan 29, 2019Product Flag?Substance Flag?Delist Request?
Patent:  Start 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:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
Approval Date:May 17, 2002TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 29, 2019Product 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 020913-003 Apr 20, 2000   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-003 Apr 20, 2000   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-002 May 17, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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