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Last Updated: September 25, 2022

SIKLOS Drug Patent 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. Twelve 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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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 1
Oncodesign SAPhase 1
Simbec OrionPhase 1

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US Patents and Regulatory Information for SIKLOS

SIKLOS is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting SIKLOS

TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Addmedica Sas SIKLOS hydroxyurea TABLET;ORAL 208843-001 Dec 21, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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.