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Last Updated: August 13, 2020

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Bivalirudin - Generic Drug Details

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

Bivalirudin is the generic ingredient in four branded drugs marketed by Sandoz Inc, Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Shuangcheng, Maia Pharms Inc, and Baxter Hlthcare Corp, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for bivalirudin. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for bivalirudin

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Recent Clinical Trials for bivalirudin

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

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Generic filers with tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial250MG/VIALINJECTABLE;INTRAVENOUS
  Start Trial  Start Trial250MG/VIALINJECTABLE;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 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
Sandoz Inc ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Dr Reddys Labs Ltd BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 201577-001 May 26, 2017 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
Fresenius Kabi Usa BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090189-001 Oct 28, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Shuangcheng BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 210031-001 Oct 23, 2019 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
>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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