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Last Updated: June 14, 2021

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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, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hong Kong, 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. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for bivalirudin

See drug prices for bivalirudin

Recent Clinical Trials for bivalirudin

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

Wuhan UniversityPhase 3
The First Affiliated Hospital of Zhengzhou UniversityPhase 3
Zhejiang UniversityPhase 3

See all bivalirudin clinical trials

Generic filers with tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started Free250MG/VIALINJECTABLE;INTRAVENOUS
  Get Started Free  Get Started Free250MG/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
Mylan Institutional BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 202471-001 Jun 1, 2018 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Accord Hlthcare BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551-001 Nov 22, 2017 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Aurobindo Pharma Ltd BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 205962-001 Jul 27, 2018 AP RX No No   Get Started Free   Get Started Free   Get Started Free
Baxter Hlthcare Corp BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374-001 Dec 21, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Sandoz Inc ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.