Details for New Drug Application (NDA): 215974
The generic ingredient in SUNLENCA is lenacapavir sodium. There is one drug master file entry for this compound. 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:
INDICATED FOR ORAL LOADING AS A COMPONENT OF THE INITIATION REGIMEN FOR BICTEGRAVIR AND LENACAPAVIR FIXED-DOSE COMBINATION TABLETS, A COMPLETE REGIMEN FOR THE TREATMENT OF HIV-1 INFECTION, IN ADULTS TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO KNOWN OR SUSPECTED RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BICTEGRAVIR AND LENACAPAVIR 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, Inc. | 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, Inc. | 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: | Aug 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR ORAL LOADING AS A COMPONENT OF THE INITIATION REGIMEN FOR BICTEGRAVIR AND LENACAPAVIR FIXED-DOSE COMBINATION TABLETS, A COMPLETE REGIMEN FOR THE TREATMENT OF HIV-1 INFECTION, IN ADULTS TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO KNOWN OR SUSPECTED RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BICTEGRAVIR AND LENACAPAVIR | ||||||||
| Regulatory Exclusivity Expiration: | Dec 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 17, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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