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Last Updated: September 26, 2020

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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.

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

Summary for urea c-13
US Patents:0
Tradenames:4
Applicants:3
NDAs:3
Drug Master File Entries: 33
Bulk Api Vendors: 28
Patent Applications: 25
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   Start Trial   Start Trial   Start Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Dxs Devices PYLORI-CHEK BREATH TEST urea c-13 FOR SOLUTION;ORAL 020900-001 Feb 4, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
>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 BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001   Start Trial   Start Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996   Start Trial   Start Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996   Start Trial   Start Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Medtronic
AstraZeneca
Colorcon
Harvard Business School

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