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Serving 500+ biopharmaceutical companies globally:

Fuji
McKesson
US Army
Daiichi Sankyo
McKinsey
Dow
Colorcon
Farmers Insurance
Boehringer Ingelheim
Novartis

Generated: August 17, 2017

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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 bivalirudin patent protection?

Bivalirudin
is the generic ingredient in two branded drugs marketed by Hospira Inc, The Medicines Co, Apotex Inc, Dr Reddys Labs Ltd, and Fresenius Kabi Usa, 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. Seven suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: bivalirudin

Tradenames:2
Patents:2
Applicants:5
NDAs:6
Drug Master File Entries: see list13
Suppliers / Packagers: see list7
Bulk Api Vendors: see list20
Clinical Trials: see list51
Patent Applications: see list4,138
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bivalirudin at DailyMed

Pharmacology for Ingredient: bivalirudin

Tentative approvals for BIVALIRUDIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe250MG/VIALINJECTABLE;INTRAVENOUS
► Subscribe► Subscribe250MGINJECTABLE;INJECTION
► Subscribe► Subscribe250MGINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
BIVALIRUDIN
bivalirudin
INJECTABLE;INTRAVENOUS201577-001May 26, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Hospira Inc
BIVALIRUDIN
bivalirudin
INJECTABLE;INTRAVENOUS090811-001Jul 14, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
The Medicines Co
ANGIOMAX
bivalirudin
INJECTABLE;INTRAVENOUS020873-001Dec 15, 2000APRXYesYes► Subscribe► SubscribeY► Subscribe
The Medicines Co
ANGIOMAX
bivalirudin
INJECTABLE;INTRAVENOUS020873-001Dec 15, 2000APRXYesYes► Subscribe► SubscribeY► Subscribe
Hospira Inc
BIVALIRUDIN
bivalirudin
INJECTABLE;INTRAVENOUS090816-001Jul 14, 2015APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bivalirudin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
The Medicines Co
ANGIOMAX
bivalirudin
INJECTABLE;INTRAVENOUS020873-001Dec 15, 2000► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Daiichi Sankyo
Farmers Insurance
Fish and Richardson
Fuji
Chinese Patent Office
Novartis
Baxter
Boehringer Ingelheim
Julphar

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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