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Last Updated: November 2, 2024

Urea c-13 - Generic Drug Details


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What are the generic sources for urea c-13 and what is the scope of freedom to operate?

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

Summary for urea c-13
US Patents:0
Tradenames:4
Applicants:3
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 50
Patent Applications: 197
What excipients (inactive ingredients) are in urea c-13?urea c-13 excipients list
DailyMed Link:urea c-13 at DailyMed

US Patents and Regulatory Information for urea c-13

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metabolic Solutions HELICOSOL urea c-13 FOR SOLUTION;ORAL 021092-001 Dec 17, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dxs Devices PYLORI-CHEK BREATH TEST urea c-13 FOR SOLUTION;ORAL 020900-001 Feb 4, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for 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;ORAL 020586-001 Sep 17, 1996 ⤷  Sign Up ⤷  Sign Up
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 ⤷  Sign Up ⤷  Sign Up
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996 ⤷  Sign Up ⤷  Sign Up
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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