Last Updated: September 28, 2026

HYDROXYUREA Drug Patent Profile

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When do Hydroxyurea patents expire, and what generic alternatives are available?

Hydroxyurea is a drug marketed by Barr, Barr Labs Inc, Leading, Ph Health, Qilu, and Roxane. and is included in seven NDAs.

The generic ingredient in HYDROXYUREA is hydroxyurea. Fourteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hydroxyurea

A generic version of HYDROXYUREA was approved as hydroxyurea by BARR on October 16^th, 1998.

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Summary for HYDROXYUREA

US Patents:	0
Applicants:	6
NDAs:	7

US Patents and Regulatory Information for HYDROXYUREA

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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
Barr	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075143-002	Sep 21, 2000		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Qilu	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	218021-001	Mar 6, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Barr Labs Inc	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075020-001	Jul 30, 1998		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Roxane	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	074476-001	Aug 18, 1995		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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.