DrugPatentWatch Database Preview
WINLEVI Drug Patent Profile
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When do Winlevi patents expire, and when can generic versions of Winlevi launch?
Winlevi is a drug marketed by Sun Pharm 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. One supplier is listed for this compound. Additional details are available on the clascoterone profile page.
DrugPatentWatch® Generic Entry Outlook for Winlevi
Winlevi will be eligible for patent challenges on August 26, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Patent Applications: | 83 |
| What excipients (inactive ingredients) are in WINLEVI? | WINLEVI excipients list |
| DailyMed Link: | WINLEVI at DailyMed |
DrugPatentWatch® Estimated 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.
Pharmacology for WINLEVI
| Drug Class | Androgen Receptor Inhibitor |
| Mechanism of Action | Androgen Receptor Antagonists |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 |
|---|---|---|
| Denmark | 1421099 | ⤷ Try it Free |
| Slovenia | 2503004 | ⤷ Try it Free |
| South Korea | 20100044845 | ⤷ Try it Free |
| Lithuania | 2966175 | ⤷ Try it Free |
| South Korea | 101495192 | ⤷ Try it Free |
| Mexico | 2010001256 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
