Hydroxyurea - Generic Drug Details

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

Hydroxyurea is the generic ingredient in five branded drugs marketed by Cheplapharm, Barr, Barr Labs Inc, Endo Operations, Leading, Qilu, Roxane, Nova Labs Ltd, and Theravia, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for hydroxyurea. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for hydroxyurea

US Patents:	0
Tradenames:	5
Applicants:	9
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	288
Patent Applications:	3,970
Drug Prices:	Drug price trends for hydroxyurea
What excipients (inactive ingredients) are in hydroxyurea?	hydroxyurea excipients list
DailyMed Link:	hydroxyurea at DailyMed

See drug prices for hydroxyurea

Recent Clinical Trials for hydroxyurea

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Italfarmaco	Phase 3
Merck Sharp & Dohme LLC	Phase 3
Children's Hospital Los Angeles	Phase 1/Phase 2

See all hydroxyurea clinical trials

Generic filers with tentative approvals for HYDROXYUREA

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG/ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydroxyurea

Drug Class	Antimetabolite

Medical Subject Heading (MeSH) Categories for hydroxyurea

Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for hydroxyurea

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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
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roxane	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	074476-001	Aug 18, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	HYDROXYUREA	hydroxyurea	TABLET;ORAL	075734-001	Aug 29, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-002	Dec 21, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cheplapharm	DROXIA	hydroxyurea	CAPSULE;ORAL	016295-002	Feb 25, 1998		RX	Yes	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

Expired US Patents for hydroxyurea

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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