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Last Updated: November 27, 2022

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. There is one tentative approval for this compound.

Recent Clinical Trials for tirofiban hydrochloride

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

SponsorPhase
Beijing Tiantan HospitalPhase 4
GrandPharma (China) Co., Ltd.Phase 4
Beijing Healthunion Cardio-Cerebrovascular Disease Prevention and Treatment FoundationPhase 4

See all tirofiban hydrochloride clinical trials

Generic filers with tentative approvals for TIROFIBAN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)SOLUTION;INTRAVENOUS

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 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 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;INTRAVENOUS 020913-001 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
Gland Pharma Ltd TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 206888-001 Apr 8, 2021 AP RX No No 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 INJECTABLE;INJECTION 020912-001 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 tirofiban hydrochloride

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 SOLUTION;INJECTION 020912-002 Aug 31, 2016 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for tirofiban hydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 03092767 See Plans and Pricing
European Patent Office 1503753 METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION) See Plans and Pricing
Japan 2005532306 See Plans and Pricing
Canada 2483929 METHODE PERMETTANT D'INHIBER L'AGREGATION PLAQUETTAIRE (A METHOD FOR INHIBITING PLATELET AGGREGATION) See Plans and Pricing
Australia 2003234596 A METHOD FOR INHIBITING PLATELET AGGREGATION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tirofiban hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Express Scripts

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