Urea c-13 - Generic Drug Details

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
Otsuka America	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	FOR SOLUTION;ORAL	020586-001	Sep 17, 1996		DISCN	No	No
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001		DISCN	No	No
Dxs Devices	PYLORI-CHEK BREATH TEST	urea c-13	FOR SOLUTION;ORAL	020900-001	Feb 4, 1999		DISCN	No	No
Metabolic Solutions	HELICOSOL	urea c-13	FOR SOLUTION;ORAL	021092-001	Dec 17, 1999		DISCN	No	No

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	4,830,010
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001	5,140,993
Otsuka America	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	FOR SOLUTION;ORAL	020586-001	Sep 17, 1996	4,830,010
Otsuka America	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	FOR SOLUTION;ORAL	020586-001	Sep 17, 1996	5,140,993