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Last Updated: November 2, 2024

Tirofiban hydrochloride - Generic Drug Details


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What are the generic drug sources for tirofiban hydrochloride and what is the scope of patent protection?

Tirofiban hydrochloride is the generic ingredient in two branded drugs marketed by Medicure, Eugia Pharma, Gland Pharma Ltd, and Nexus, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for tirofiban hydrochloride

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

SponsorPhase
The First Affiliated Hospital of University of Science and Technology of ChinaPhase 3
Pharmaron (Chengdu) Clinical Services Co., Ltd.Phase 3
Peking Union Medical College HospitalPhase 3

See all tirofiban hydrochloride clinical trials

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
Nexus TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 213947-001 Feb 7, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 206888-001 Apr 8, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INJECTION 020912-002 Aug 31, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 216379-001 May 1, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma TIROFIBAN HYDROCHLORIDE tirofiban hydrochloride SOLUTION;INTRAVENOUS 216379-002 May 1, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 020913-001 May 14, 1998 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride INJECTABLE;INJECTION 020912-001 May 14, 1998 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-003 Apr 20, 2000 ⤷  Sign Up ⤷  Sign Up
Medicure AGGRASTAT tirofiban hydrochloride SOLUTION;INTRAVENOUS 020913-001 May 14, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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