Details for New Drug Application (NDA): 221104
NDA 221104 describes BIXLENVO, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the BIXLENVO profile page.
The generic ingredient in BIXLENVO is bictegravir sodium, lenacapavir sodium; lenacapavir sodium . There are two drug master file entries 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 is bictegravir sodium, lenacapavir sodium; lenacapavir sodium . There are two drug master file entries 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 221104
| Tradename: | BIXLENVO |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | bictegravir sodium; lenacapavir sodium |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 221104
Generic Entry Date for 221104*:
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.
Pharmacology for NDA: 221104
Suppliers and Packaging for NDA: 221104
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BIXLENVO | bictegravir sodium; lenacapavir sodium | TABLET;ORAL | 221104 | NDA | Gilead Sciences, Inc. | 61958-3601 | 61958-3601-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3601-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE;EQ 50MG 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: | 10,071,985 | Patent Expiration: | Aug 17, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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