Urea - Generic Drug Details

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What are the generic sources for urea and what is the scope of patent protection?

Urea is the generic ingredient in eight branded drugs marketed by Hospira, Otsuka America, Metabolic Solutions, Dxs Devices, and Avent, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

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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
Hospira	UREAPHIL	urea	INJECTABLE;INJECTION	012154-001	Approved Prior to Jan 1, 1982		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
Metabolic Solutions	HELICOSOL	urea c-13	FOR SOLUTION;ORAL	021092-001	Dec 17, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avent	PYTEST	urea, c-14	CAPSULE;ORAL	020617-001	May 9, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	STERILE UREA	urea	INJECTABLE;INJECTION	017698-001	Approved Prior to Jan 1, 1982		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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	8
Applicants:	5
NDAs:	6
Drug Master File Entries:	33
Raw Ingredient (Bulk) Api Vendors:	216
Patent Applications:	6,220
Drug Prices:	Drug price trends for urea
DailyMed Link:	urea at DailyMed