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Last Updated: April 25, 2024

Hydroxyurea - Generic Drug Details

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

Hydroxyurea is the generic ingredient in four branded drugs marketed by Cheplapharm, Barr, Barr Labs Inc, Leading, Par Pharm, Qilu, Roxane, and Theravia, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for hydroxyurea

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	9
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	283
Patent Applications:	3,970
Formulation / Manufacturing:	see details
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
Novartis	Phase 1/Phase 2
Children's Hospital Los Angeles	Phase 1/Phase 2
Institute of Hematology & Blood Diseases Hospital	Phase 2

See all hydroxyurea clinical trials

Generic filers with tentative approvals for HYDROXYUREA

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	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
Barr	HYDROXYUREA	hydroxyurea	TABLET;ORAL	075734-001	Aug 29, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075143-002	Sep 21, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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