small molecule

BIXLENVO

BICTEGRAVIR SODIUM; LENACAPAVIR SODIUM

Loss of exclusivityAugust 2038latest FDA-listed patent expiry
CompanyGILEAD SCIENCES INC

Drug detail

Brand nameBIXLENVO
Active ingredientBICTEGRAVIR SODIUM; LENACAPAVIR SODIUM
StrengthEQ 75MG BASE;EQ 50MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalAugust 2026
Marketing statusRX

Listed patents

PatentExpiresType
11267799August 2038substance
10071985August 2037substance, product
10654827August 2037use U-4602
9708342June 2035substance, product
10385067June 2035use U-4602
9951043February 2034substance, product
9216996December 2033substance, product
9732092December 2033substance, product

Regulatory exclusivity

CodeExpires
NPAugust 2029
NCEDecember 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.