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Urea c-13 - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for urea c-13?

Urea c-13 is the generic ingredient in four branded drugs marketed by Dxs Devices, Otsuka America, and Metabolic Solutions, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for urea c-13.

Summary for Generic Name: urea c-13

Tradenames:4
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list32
Bulk Api Vendors: see list11
Clinical Trials: see list157
Patent Applications: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:urea c-13 at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date 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
Dxs Devices
PYLORI-CHEK BREATH TEST
urea c-13
FOR SOLUTION;ORAL020900-001Feb 4, 1999DISCNNoNo► Subscribe► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 1996DISCNNoNo► Subscribe► Subscribe
Metabolic Solutions
HELICOSOL
urea c-13
FOR SOLUTION;ORAL021092-001Dec 17, 1999DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: urea c-13

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 19964,830,010► Subscribe
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 20015,140,993► Subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 19965,140,993► Subscribe
Otsuka America
BREATHTEK UBT FOR H-PYLORI
urea c-13
FOR SOLUTION;ORAL020586-002May 10, 20014,830,010► Subscribe
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