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  1. pharmadog
  2. ›drugs
  3. ›Biktarvy
drug
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(bictegravir sodium + emtricitabine + tenofovir alafenamide)

Marketedupdated 3mo ago
by $GILD GILEAD SCIENCES, INC.
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying (bictegravir sodium + emtricitabine + tenofovir alafenamide)

  • phase4Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteerscompletedn=20
  • phase3The Late Presenter Treatment Optimisation Studycompletedn=447
  • phase4Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Programcompletedn=27
  • N/ADevelopment of a Silica Microparticle Taggant System to Measure ART Adherencenot yet recruitingn=15
  • phase1Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvircompletedn=28
  • phase3A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressedcompletedn=687
  • —Bictegravir in the Elderly Living With HIV (BICEP)active not recruitingn=162
  • phase4Efficacy, Tolerability and Acceptability of Biktarvy by TPLWHterminatedn=1
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Feb 23, 2027
195 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (18)

  • Nov 8, 2036formulationUS 10548846
  • Nov 8, 2036formulationUS 11744802
  • Jun 19, 2035method-of-use (U-257)US 10385067
  • Jun 19, 2035method-of-use (U-257)US 10385067
  • Jun 19, 2035compositionUS 9708342
  • Jun 19, 2035compositionUS 9708342
  • Dec 19, 2033compositionUS 9216996
  • Dec 19, 2033compositionUS 9216996
  • Dec 19, 2033compositionUS 9732092
  • Dec 19, 2033compositionUS 9732092
  • Feb 15, 2033patentUS 8754065*PED
  • Feb 15, 2033patentUS 8754065*PED
  • Feb 15, 2033patentUS 9296769*PED
  • Feb 15, 2033patentUS 9296769*PED
  • Aug 15, 2032compositionUS 8754065
  • Aug 15, 2032compositionUS 8754065
  • Aug 15, 2032compositionUS 9296769
  • Aug 15, 2032compositionUS 9296769

FDA exclusivities (7)

  • Feb 23, 2031ODE-468Orphan Drug (7y)4.5y
  • Feb 23, 2031ODE-468Orphan Drug (7y)4.5y
  • Oct 7, 2028ODE-378Orphan Drug (7y)2.2y
  • Apr 24, 2027M-305Method (3y)255d
  • Feb 23, 2027I-942Indication (3y)195d
  • Feb 23, 2027I-942Indication (3y)195d
  • Jun 18, 2026ODE-256Orphan Drug (7y)

News(6)

  • Earnings roundup: Gilead’s ‘uncertain’ future, Pfizer’s crossroads and Merck’s PCSK9 launch
    Some analysts see warning signs in crucial drug launches from Gilead and Merck, while an important trial readout could change Pfizer’s growth trajectory.
    biopharma_dive · 6d ago
  • Gilead looks to upcoming inflammation, cancer catalysts as pressure to diversify mounts
    HIV remained Gilead’s strongest franchise in the second quarter, but the pharma is building out its pipeline beyond virology, particularly focusing on inflammation and oncology.
    biospace · 6d ago
  • Merck stages expanded access to monthly HIV PrEP pill ahead of approval
    Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.
    fiercebiotech · 19d ago
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    biopharma_dive · 20d ago
  • STAT+: Sales from controversial U.S. drug discount program rose to $100 billion last year
    Prescription drugs purchased under a controversial government discount program amounted to $100 billion in 2025, a 22.8% increase from the previous year.
    stat · 28d ago
  • Merck adds to pharma’s AI push; Roche details MS drug results
    Merck is making a $1 billion investment in a deal with Google Cloud. Elsewhere, Roche pitched its case for a closely watched multiple sclerosis pill and Arcus and Gilead are ending a yearslong alli…
    biopharma_dive · 3mo ago
brand
Biktarvy
generic
(bictegravir sodium + emtricitabine + tenofovir alafenamide)
indication
Human Immunodeficiency Virus (HIV) Infections (AIDS)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 1h ago
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