Last Updated: September 24, 2026

Urea c-13 - Generic Drug Details

Name: urea c-13 Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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
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

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Glossary

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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
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

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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