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Last Updated: March 8, 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 one branded drug marketed by Medicure and is included in two 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. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for tirofiban hydrochloride

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

SponsorPhase
Fondazione "Un Cuore per Milano" - a no profit foundationPhase 2
University of MilanPhase 2
Assiut UniversityPhase 1/Phase 2

See all tirofiban hydrochloride clinical trials

Generic filers with tentative approvals for TIROFIBAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for tirofiban hydrochloride
Paragraph IV (Patent) Challenges for TIROFIBAN HYDROCHLORIDE
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 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   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 020913-002 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020913-001 May 14, 1998   Start Trial   Start Trial
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016   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 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 tirofiban hydrochloride

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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Express Scripts

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