Details for New Drug Application (NDA): 221443
NDA 221443 describes BIXLENVO SUNLENCA STARTER PACK (COPACKAGED), which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) profile page.
The generic ingredient in BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) is bictegravir sodium, lenacapavir sodium; 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 bictegravir sodium, lenacapavir sodium; lenacapavir sodium profile page.
The generic ingredient in BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) is bictegravir sodium, lenacapavir sodium; 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 bictegravir sodium, lenacapavir sodium; lenacapavir sodium profile page.
Summary for 221443
| Tradename: | BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | bictegravir sodium, lenacapavir sodium; lenacapavir sodium |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 221443
Generic Entry Date for 221443*:
Constraining patent/regulatory exclusivity:
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: 221443
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIXLENVO SUNLENCA STARTER PACK (COPACKAGED) | bictegravir sodium, lenacapavir sodium; lenacapavir sodium | TABLET;ORAL | 221443 | NDA | Gilead Sciences, Inc. | 61958-3701 | 61958-3701-1 | 1 KIT in 1 CARTON (61958-3701-1) * 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-3) * 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE | ||||
| Approval Date: | Aug 27, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 22, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Aug 17, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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