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Last Updated: August 11, 2022

AGGRASTAT Drug Patent Profile


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Which patents cover Aggrastat, and when can generic versions of Aggrastat launch?

Aggrastat is a drug marketed by Medicure and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has five patent family members in five countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Aggrastat

A generic version of AGGRASTAT was approved as tirofiban hydrochloride by GLAND PHARMA LTD on April 8th, 2021.

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Drug patent expirations by year for AGGRASTAT
Drug Prices for AGGRASTAT

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Recent Clinical Trials for AGGRASTAT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of IowaPhase 1/Phase 2
David HasanPhase 1/Phase 2
University Hospital Inselspital, BernePhase 4

See all AGGRASTAT clinical trials

Pharmacology for AGGRASTAT
Paragraph IV (Patent) Challenges for AGGRASTAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AGGRASTAT Injection tirofiban hydrochloride 5 mg/100 mL 020913 1 2019-08-29
AGGRASTAT Injection tirofiban hydrochloride 12.5 mg/250 mL 020913 1 2018-10-03

US Patents and Regulatory Information for AGGRASTAT

AGGRASTAT is protected by one US patents.

Patents protecting AGGRASTAT

Method for inhibiting platelet aggregation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-002 May 17, 2002 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-001 May 14, 1998 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AGGRASTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-002 May 17, 2002 See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-001 May 14, 1998 See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 See Plans and Pricing See Plans and Pricing
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AGGRASTAT

See the table below for patents covering AGGRASTAT around the world.

Country Patent Number Title Estimated Expiration
Canada 2483929 METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION) See Plans and Pricing
Russian Federation 2116296 SULFONAMIDE DERIVATIVES, PHARMACEUTICAL COMPOSITION BASED ON THEREOF, METHOD OF INHIBITION OF FIBRIN EFFECT AND A METHOD OF TREATMENT OF MAMMALIAN WITH THROMBOSIS See Plans and Pricing
China 1200676 See Plans and Pricing
Singapore 63636 Novel sulfonamide fibrinogen receptor antagonists See Plans and Pricing
Australia 740941 See Plans and Pricing
Slovakia 282353 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AGGRASTAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0478363 C990040 Netherlands See Plans and Pricing PRODUCT NAME: TIROFIBAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN HYDRAAT, IN HET BIJZONDER TIROFIBANHY- DROCHLORIDE MONOHYDRAAT; NATL REGISTRATION NO/DATE: RVG 23380-1 19990707; FIRST REGISTRATION: DE 42618.00.00-01 19980630
0478363 2000C/002 Belgium See Plans and Pricing PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528
0478363 SPC/GB99/042 United Kingdom See Plans and Pricing PRODUCT NAME: TIROFIBAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE HYDROCHLORIDE; REGISTERED: LI 54761 19980528; CH 54761 19980528; DE 42618.00.00 19980630; DE 42618.00.01 19980630; DE 42620.00.00 19980630; DE 42620.00.01 19980630; UK PL 00025/0375 19990715; UK PL 00025/0376 19990715
0478363 48/1999 Austria See Plans and Pricing PRODUCT NAME: TIROFIBAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-23140 UND 1-23141 19990714; FIRST REGISTRATION: LI IKS-NR 54761 19980528
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
McKinsey
Merck
Johnson and Johnson
Dow

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