small molecule

BIKTARVY

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Loss of exclusivityNovember 2036latest FDA-listed patent expiry
CompanyGilead SciencesView the full company profile on CliffBio

Drug detail

Brand nameBIKTARVY
Active ingredientBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
StrengthEQ 50MG BASE;200MG;EQ 25MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2018
Marketing statusRX

Listed patents

PatentExpiresType
12594244November 2036product
11744802November 2036product
10548846November 2036product
9708342June 2035substance, product
10385067June 2035use U-257
9216996December 2033substance, product
9732092December 2033substance, product
8754065*PEDFebruary 2033
9296769*PEDFebruary 2033
9296769August 2032substance, product
8754065August 2032substance, product

Regulatory exclusivity

CodeExpires
ODE-540July 2032
ODE-468February 2031
M-305April 2027
I-942February 2027
ODE-256June 2026

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.

BIKTARVY patent cliff — loss of exclusivity November 2036 | CliffBio