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Last Updated: August 8, 2020

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BIVALIRUDIN Drug Profile

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When do Bivalirudin patents expire, and what generic alternatives are available?

Bivalirudin is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Shuangcheng, and Baxter Hlthcare Corp. and is included in eleven NDAs.

The generic ingredient in BIVALIRUDIN is bivalirudin. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

US ANDA Litigation and Generic Entry Outlook for Bivalirudin

A generic version of BIVALIRUDIN was approved as bivalirudin by HOSPIRA INC on July 14th, 2015.

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Drug patent expirations by year for BIVALIRUDIN
Drug Prices for BIVALIRUDIN

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Recent Clinical Trials for BIVALIRUDIN

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

SponsorPhase
Hamad Medical CorporationPhase 4
Shanghai Zhongshan HospitalPhase 4
Second Xiangya Hospital of Central South UniversityPhase 4

See all BIVALIRUDIN clinical trials

Pharmacology for BIVALIRUDIN
Paragraph IV (Patent) Challenges for BIVALIRUDIN
Tradename Dosage Ingredient NDA Submissiondate
ANGIOMAX INJECTABLE;INTRAVENOUS bivalirudin 020873 2009-09-01

US Patents and Regulatory Information for BIVALIRUDIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551-001 Nov 22, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090811-001 Jul 14, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Cipla BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 091602-001 Jul 16, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374-002 Dec 21, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816-001 Jul 14, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Apotex BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 204876-001 Jul 6, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 205962-001 Jul 27, 2018 AP RX 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

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