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. Sixteen 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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Questions you can ask:
- What is the 5 year forecast for SIKLOS?
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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: | 1,706 |
| 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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Theravia | SIKLOS | hydroxyurea | TABLET;ORAL | 208843-001 | Dec 21, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
