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Serving leading biopharmaceutical companies globally:

Julphar
Fuji
Cantor Fitzgerald
Cipla
Teva
McKinsey
Colorcon
Covington
McKesson
Novartis

Generated: January 18, 2018

DrugPatentWatch Database Preview

BIVALIRUDIN - Generic Drug Details

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

Bivalirudin
is the generic ingredient in two branded drugs marketed by The Medicines Co, Apotex Inc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, and Hospira Inc, and is included in six 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 thirteen drug master file entries for bivalirudin. Six suppliers are listed for this compound. There are four tentative approvals for this compound.
Pharmacology for BIVALIRUDIN
Tentative approvals for BIVALIRUDIN
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe250MG/VIALINJECTABLE;INTRAVENOUS
➤ Subscribe➤ Subscribe250MGINJECTABLE;INJECTION
➤ Subscribe➤ Subscribe250MGINJECTABLE;INJECTION

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
Apotex Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 204876-001 Jul 6, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Ltd BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 201577-001 May 26, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
The Medicines Co ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816-001 Jul 14, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
The Medicines Co ANGIOMAX bivalirudin INJECTABLE;INTRAVENOUS 020873-001 Dec 15, 2000 AP RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hospira Inc BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090811-001 Jul 14, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090189-001 Oct 28, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Serving leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Mallinckrodt
McKinsey
Dow
Julphar
Medtronic
Federal Trade Commission
Chinese Patent Office

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 verifification 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.

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