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Last Updated: July 12, 2020

DrugPatentWatch Database Preview

AGGRASTAT Drug 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. One supplier is listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Aggrastat

Aggrastat was eligible for patent challenges on May 14, 2002.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2023. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tirofiban hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for AGGRASTAT
Drug Prices for AGGRASTAT

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Generic Entry Opportunity Date for AGGRASTAT
Generic Entry Dates for AGGRASTAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION
Generic Entry Dates for AGGRASTAT*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for AGGRASTAT

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

SponsorPhase
David HasanPhase 1/Phase 2
University Hospital Inselspital, BernePhase 4
Second Hospital of Jilin UniversityPhase 4

See all AGGRASTAT clinical trials

Pharmacology for AGGRASTAT
Paragraph IV (Patent) Challenges for AGGRASTAT
Tradename Dosage Ingredient NDA Submissiondate
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2019-08-29
AGGRASTAT INJECTABLE;INJECTION tirofiban hydrochloride 020913 2018-10-03

US Patents and Regulatory Information for AGGRASTAT

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 020913-002 May 17, 2002 RX Yes No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-003 Apr 20, 2000 RX Yes Yes   Start Trial   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 INJECTABLE;INJECTION 020913-003 Apr 20, 2000   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 020913-002 May 17, 2002   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-002 May 17, 2002   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AGGRASTAT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0478363 C990040 Netherlands   Start Trial 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 SPC/GB99/042 United Kingdom   Start Trial 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   Start Trial 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
0478363 2000C/002 Belgium   Start Trial PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.