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Last Updated: June 18, 2021

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SIKLOS Drug Profile


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Which patents cover Siklos, and when can generic versions of Siklos launch?

Siklos is a drug marketed by Addmedica Sas and is included in one NDA.

The generic ingredient in SIKLOS is hydroxyurea. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Siklos

A generic version of SIKLOS was approved as hydroxyurea by BARR on October 16th, 1998.

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Summary for SIKLOS
Drug patent expirations by year for SIKLOS
Drug Prices for SIKLOS

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Recent Clinical Trials for SIKLOS

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

SponsorPhase
Emory UniversityPhase 3
Global Health Uganda LTDPhase 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 3

See all SIKLOS clinical trials

US Patents and Regulatory Information for SIKLOS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Addmedica Sas SIKLOS hydroxyurea TABLET;ORAL 208843-002 Dec 21, 2017 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Addmedica Sas SIKLOS hydroxyurea TABLET;ORAL 208843-001 Dec 21, 2017 RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Harvard Business School
Colorcon
Dow
Boehringer Ingelheim

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