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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Cipla
McKinsey
QuintilesIMS
Express Scripts
Baxter
Merck
US Department of Justice
Fish and Richardson
Mallinckrodt

Generated: November 19, 2017

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Urea - Generic Drug Details

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

Urea
is the generic ingredient in eight branded drugs marketed by Hospira, Dxs Devices, Otsuka America, Metabolic Solutions, and Avent, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-three drug master file entries for urea.

Summary for urea

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
STERILE UREA
urea
INJECTABLE;INJECTION017698-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Metabolic Solutions
HELICOSOL
urea c-13
FOR SOLUTION;ORAL021092-001Dec 17, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Avent
PYTEST
urea, c-14
CAPSULE;ORAL020617-001May 9, 1997RXYesYes► Subscribe► Subscribe► Subscribe
Avent
PYTEST KIT
urea, c-14
CAPSULE;ORAL020617-002May 9, 1997RXYesYes► Subscribe► Subscribe► Subscribe
Dxs Devices
PYLORI-CHEK BREATH TEST
urea c-13
FOR SOLUTION;ORAL020900-001Feb 4, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
UREAPHIL
urea
INJECTABLE;INJECTION012154-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Chinese Patent Office
Daiichi Sankyo
Argus Health
Teva
Julphar
Mallinckrodt
Novartis
AstraZeneca

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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