Details for New Drug Application (NDA): 215974
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The generic ingredient in SUNLENCA is lenacapavir sodium. One supplier is listed for this compound. Additional details are available on the lenacapavir sodium profile page.
Summary for 215974
Tradename: | SUNLENCA |
Applicant: | Gilead Sciences Inc |
Ingredient: | lenacapavir sodium |
Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215974
Generic Entry Date for 215974*:
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: 215974
Suppliers and Packaging for NDA: 215974
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974 | NDA | Gilead Sciences | 61958-3001 | 61958-3001-1 | 1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK |
SUNLENCA | lenacapavir sodium | TABLET;ORAL | 215974 | NDA | Gilead Sciences | 61958-3001 | 61958-3001-2 | 1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Dec 22, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 22, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 17, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 17, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | IN COMBINATION WITH OTHER ANTIRETROVIRAL(S), FOR THE TREATMENT OF HIV-1 INFECTION IN HEAVILY-TREATMENT EXPERIENCED ADULTS WITH MULTIDRUG RESISTANT HIV-1 INFECTION |
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