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Last Updated: August 3, 2020

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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.

US ANDA 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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Drug patent expirations by year for SIKLOS
Drug Prices for SIKLOS

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Recent Clinical Trials for SIKLOS

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SponsorPhase
ADDMEDICA SASAPhase 2
Doris Duke Charitable FoundationPhase 3
Indiana UniversityPhase 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 No   Start Trial   Start Trial   Start Trial
Addmedica Sas SIKLOS hydroxyurea TABLET;ORAL 208843-001 Dec 21, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Addmedica Sas SIKLOS hydroxyurea TABLET;ORAL 208843-002 Dec 21, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Addmedica Sas SIKLOS hydroxyurea TABLET;ORAL 208843-001 Dec 21, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>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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