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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.
A generic version of SIKLOS was approved as hydroxyurea by BARR on October 16th, 1998.
Recent Clinical Trials for SIKLOS
Identify potential brand extensions & 505(b)(2) entrants
|ADDMEDICA SASA||Phase 1|
|Oncodesign SA||Phase 1|
|Simbec Orion||Phase 1|
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|