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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215974


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NDA 215974 describes SUNLENCA, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the SUNLENCA profile page.

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.

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:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Dec 22, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2027
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Aug 17, 2037Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 17, 2037Product 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.