gedatolisib - Profile
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What are the generic sources for gedatolisib and what is the scope of freedom to operate?
Gedatolisib
is the generic ingredient in one branded drug marketed by Celcuity and is included in one NDA. Additional information is available in the individual branded drug profile pages.DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for gedatolisib
Generic Entry Date for gedatolisib*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
POWDER;INTRAVENOUS |
*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 gedatolisib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celcuity | REVTORPYK | gedatolisib | POWDER;INTRAVENOUS | 219908-001 | Jul 14, 2026 | 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 |
