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Last Updated: November 21, 2024

HYDROXYUREA - Generic Drug Details


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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.

Summary for HYDROXYUREA
Drug Prices for HYDROXYUREA

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Recent Clinical Trials for HYDROXYUREA

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

SponsorPhase
ItalfarmacoPhase 3
Merck Sharp & Dohme LLCPhase 3
NovartisPhase 1/Phase 2

See all HYDROXYUREA clinical trials

Generic filers with tentative approvals for HYDROXYUREA
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up100MG/MLSOLUTION;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 ClassAntimetabolite
Medical Subject Heading (MeSH) Categories for HYDROXYUREA

US Patents and Regulatory Information for HYDROXYUREA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leading HYDROXYUREA hydroxyurea CAPSULE;ORAL 213438-001 Apr 8, 2020 AB RX No No ⤷  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
Barr HYDROXYUREA hydroxyurea CAPSULE;ORAL 075143-001 Oct 16, 1998 AB RX No 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

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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. 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.