You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 26, 2024

Hydroxyurea - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic drug 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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Cheplapharm	DROXIA	hydroxyurea	CAPSULE;ORAL	016295-002	Feb 25, 1998		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roxane	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	074476-001	Aug 18, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-002	Dec 21, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-001	Dec 21, 2017		RX	Yes	No	⤷ 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

Subscribe to access the full database, or Try a Trial
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

Make Better Decisions: Try a trial or see plans & pricing

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. 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.