Clascoterone - Generic Drug Details
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What are the generic sources for clascoterone and what is the scope of patent protection?
Clascoterone
is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Clascoterone has eighty-nine patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for clascoterone
International Patents: | 89 |
US Patents: | 9 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 4 |
Patent Applications: | 145 |
What excipients (inactive ingredients) are in clascoterone? | clascoterone excipients list |
DailyMed Link: | clascoterone at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for clascoterone
Generic Entry Date for clascoterone*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for clascoterone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chang Gung Memorial Hospital | Phase 1/Phase 2 |
Pharmapace Inc | Phase 3 |
Canfield Scientific Inc. | Phase 3 |
Pharmacology for clascoterone
Drug Class | Androgen Receptor Inhibitor |
Mechanism of Action | Androgen Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for clascoterone
US Patents and Regulatory Information for clascoterone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for clascoterone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 111351 | FORMA CRISTALINA I DEL 17-a-PROPIONATO DE CORTEXOLONA, COMPOSICIÓN FARMACÉUTICA QUE LA CONTIENE Y SU EMPLEO EN EL TRATAMIENTO DE UNA PATOLOGÍA RELACIONADA CON EL APARATO UROGENITAL, ENDÓCRINO O DE LA PIEL Y/O ANEXOS DE ÉSTA | ⤷ Sign Up |
Japan | 2010535173 | ⤷ Sign Up | |
Serbia | 58950 | FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE KORTEKSOLON-17-ALFA-PROPIONAT (PHARMACEUTICAL COMPOSITIONS CONTAINING CORTEXOLONE-17-ALPHA-PROPIONATE) | ⤷ Sign Up |
China | 1541220 | ⤷ Sign Up | |
Croatia | P20151298 | ⤷ Sign Up | |
Slovenia | 2173891 | ⤷ Sign Up | |
Spain | 2462946 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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