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 Theravia and is included in one NDA.
The generic ingredient in SIKLOS is hydroxyurea. There are ten drug master file entries for this compound. Thirteen 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.
Summary for SIKLOS
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 160 |
Clinical Trials: | 9 |
Patent Applications: | 162 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SIKLOS |
What excipients (inactive ingredients) are in SIKLOS? | SIKLOS excipients list |
DailyMed Link: | SIKLOS at DailyMed |
Recent Clinical Trials for SIKLOS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
PHINC DEVELOPMENT | Phase 1 |
ADDMEDICA SASA | Phase 1 |
Oncodesign SA | Phase 1 |
Pharmacology for SIKLOS
Drug Class | Antimetabolite |
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: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Theravia | SIKLOS | hydroxyurea | TABLET;ORAL | 208843-002 | Dec 21, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Theravia | SIKLOS | hydroxyurea | TABLET;ORAL | 208843-001 | Dec 21, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |