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. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the LEQSELVI profile page.
The generic ingredient in LEQSELVI is deuruxolitinib phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the deuruxolitinib phosphate profile page.
The generic ingredient in LEQSELVI is deuruxolitinib phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the deuruxolitinib phosphate profile page.
Summary for 217900
| Tradename: | LEQSELVI |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | deuruxolitinib phosphate |
| Patents: | 6 |
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.
Pharmacology for NDA: 217900
Suppliers and Packaging for NDA: 217900
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEQSELVI | deuruxolitinib phosphate | TABLET;ORAL | 217900 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-108 | 47335-108-86 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86) |
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: | 10,561,659 | Patent Expiration: | May 4, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH ALOPECIA AREATA | ||||||||
| Patent: | 11,919,907 | 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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