Details for New Drug Application (NDA): 217900
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NDA 217900 describes LEQSELVI, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There are three patents protecting this drug. Additional details are available on the LEQSELVI profile page.
The generic ingredient in LEQSELVI is deuruxolitinib phosphate. Additional details are available on the deuruxolitinib phosphate profile page.
The generic ingredient in LEQSELVI is deuruxolitinib phosphate. Additional details are available on the deuruxolitinib phosphate profile page.
Summary for 217900
| Tradename: | LEQSELVI |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | deuruxolitinib phosphate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217900
Generic Entry Date for 217900*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Jul 25, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 25, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 4, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH ALOPECIA AREATA | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 21, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH ALOPECIA AREATA | ||||||||
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