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Last Updated: July 30, 2021

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TIROFIBAN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for tirofiban hydrochloride and what is the scope of freedom to operate?

Tirofiban hydrochloride is the generic ingredient in two branded drugs marketed by Medicure and Gland Pharma Ltd, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirofiban hydrochloride has five patent family members in five countries.

There are four drug master file entries for tirofiban hydrochloride. Two suppliers are listed for this compound.

Recent Clinical Trials for TIROFIBAN HYDROCHLORIDE

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

SponsorPhase
University of IowaPhase 1/Phase 2
Shanghai 6th People's HospitalPhase 2/Phase 3
Ningbo No. 1 HospitalPhase 2/Phase 3

See all TIROFIBAN HYDROCHLORIDE clinical trials

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

US Patents and Regulatory Information for TIROFIBAN HYDROCHLORIDE

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 SOLUTION;INJECTION 020912-002 Aug 31, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-002 May 17, 2002 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-001 May 14, 1998 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gland Pharma Ltd TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 206888-001 Apr 8, 2021 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 TIROFIBAN HYDROCHLORIDE

Supplementary Protection Certificates for TIROFIBAN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0478363 C990040 Netherlands ⤷  Free Forever 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 2000C/002 Belgium ⤷  Free Forever Trial PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528
0478363 48/1999 Austria ⤷  Free Forever 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 SPC/GB99/042 United Kingdom ⤷  Free Forever 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
AstraZeneca
Colorcon
Express Scripts
Boehringer Ingelheim

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