HYDROXYUREA - Generic Drug Details

✉ Email this page to a colleague

What are the generic drug sources for hydroxyurea and what is the scope of freedom to operate?

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.

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

Sponsor

Phase

Italfarmaco

Phase 3

Merck Sharp & Dohme LLC

Phase 3

Children's Hospital Los Angeles

Phase 1/Phase 2

US Patents and Regulatory Information for HYDROXYUREA

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-002	Dec 21, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075340-001	Feb 24, 1999	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	218021-001	Mar 6, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr Labs Inc	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075020-001	Jul 30, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cheplapharm	DROXIA	hydroxyurea	CAPSULE;ORAL	016295-003	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

Subscribe to access the full database, or Sign Up
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

Applicant

Tradename

Generic Name

Dosage

NDA

Approval Date

Patent No.

Patent Expiration

CAPSULE;ORAL

Approved Prior to Jan 1, 1982

⤷ Sign Up

>Applicant

>Tradename

>Generic Name

>Dosage

>NDA

>Approval Date

>Patent No.

>Patent Expiration

Subscribe to access the full database, or Sign Up

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

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

HYDROXYUREA - Generic Drug Details

What are the generic drug sources for hydroxyurea and what is the scope of freedom to operate?

Summary for HYDROXYUREA

Recent Clinical Trials for HYDROXYUREA

Generic filers with tentative approvals for HYDROXYUREA

Pharmacology for HYDROXYUREA

Medical Subject Heading (MeSH) Categories for HYDROXYUREA

US Patents and Regulatory Information for HYDROXYUREA

Expired US Patents for HYDROXYUREA

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