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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
US Department of Justice
Colorcon
Express Scripts
Fish and Richardson
Harvard Business School
Dow
AstraZeneca
Merck

Generated: August 16, 2017

DrugPatentWatch Database Preview

Hydroxyurea - Generic Drug Details

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What are the generic sources for hydroxyurea and what is the scope of hydroxyurea freedom to operate?

Hydroxyurea
is the generic ingredient in three branded drugs marketed by Barr Labs Inc, Barr, Par Pharm, Roxane, and Bristol Myers Squibb, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for hydroxyurea. Eight suppliers are listed for this compound.

Summary for Generic Name: hydroxyurea

Tradenames:3
Patents:0
Applicants:5
NDAs:6
Drug Master File Entries: see list10
Suppliers / Packagers: see list8
Bulk Api Vendors: see list88
Clinical Trials: see list212
Patent Applications: see list156
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:hydroxyurea at DailyMed

Pharmacology for Ingredient: hydroxyurea

Ingredient-typeUrea
Drug ClassAntimetabolite
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr Labs Inc
HYDROXYUREA
hydroxyurea
CAPSULE;ORAL075020-001Jul 30, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe
Barr
HYDROXYUREA
hydroxyurea
CAPSULE;ORAL075143-002Sep 21, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
Par Pharm
HYDROXYUREA
hydroxyurea
CAPSULE;ORAL075340-001Feb 24, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe
Roxane
HYDROXYUREA
hydroxyurea
CAPSULE;ORAL074476-001Aug 18, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
DROXIA
hydroxyurea
CAPSULE;ORAL016295-002Feb 25, 1998RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: hydroxyurea

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
HYDREA
hydroxyurea
CAPSULE;ORAL016295-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Accenture
Novartis
Farmers Insurance
Merck
Federal Trade Commission
Cipla
Deloitte
Teva
Cerilliant
Colorcon

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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