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WINLEVI Drug Profile
» See Plans and Pricing
When do Winlevi patents expire, and when can generic versions of Winlevi launch?
Winlevi is a drug marketed by Cassiopea Spa and is included in one NDA. There are seven patents protecting this drug.
This drug has eighty-nine patent family members in twenty-six countries.
The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.
US ANDA Litigation and Generic Entry Outlook for Winlevi
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 25, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for WINLEVI
| International Patents: | 89 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | WINLEVI at DailyMed |
Generic Entry Opportunity Date for WINLEVI
Generic Entry Date for WINLEVI*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for WINLEVI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cassiopea Spa | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cassiopea Spa | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cassiopea Spa | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 WINLEVI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2503004 | Start Trial |
| Denmark | 2503005 | Start Trial |
| New Zealand | 615953 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
