Details for New Drug Application (NDA): 213433
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NDA 213433 describes WINLEVI, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the WINLEVI profile page.
The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this compound. Additional details are available on the clascoterone profile page.
The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this compound. Additional details are available on the clascoterone profile page.
Summary for 213433
| Tradename: | WINLEVI |
| Applicant: | Sun Pharm |
| Ingredient: | clascoterone |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213433
Generic Entry Date for 213433*:
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.
Pharmacology for NDA: 213433
| Mechanism of Action | Androgen Receptor Antagonists |
Suppliers and Packaging for NDA: 213433
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WINLEVI | clascoterone | CREAM;TOPICAL | 213433 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-994 | 47335-994-36 | 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE |
| WINLEVI | clascoterone | CREAM;TOPICAL | 213433 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-994 | 47335-994-94 | 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
| Approval Date: | Aug 26, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 26, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 14, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 20, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE | ||||||||
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