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  1. pharmadog
  2. ›drugs
  3. ›Dovato
drug
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(dolutegravir sodium + lamivudine)

Marketedupdated 3mo ago
by ViiV Healthcare Company
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval32 co-mentions · 16 sources
  • drugdolutegravir sodium16 co-mentions · 16 sources
  • tagSmall Molecule16 co-mentions · 16 sources
  • drugdolutegravir sodium ODT16 co-mentions · 16 sources

all catalysts(0)

nothing on the calendar yet

Trials studying (dolutegravir sodium + lamivudine)

  • phase3Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatmentrecruitingn=150
  • phase2Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudinecompletedn=121
  • phase4Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)not yet recruitingn=40
  • phase1A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participantscompletedn=33

Patent cliff

source: FDA Orange Book
first barrier falls
Apr 5, 2027
230 days

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

patents (5)

  • Jan 24, 2031formulationUS 112349854.4y
  • Jun 8, 2030patentUS 9242986*PED3.8y
  • Dec 8, 2029compositionUS 92429863.3y
  • Apr 5, 2028patentUS 8129385*PED1.6y
  • Oct 5, 2027compositionUS 81293851.1y

FDA exclusivities (1)

  • Apr 5, 2027NPPNew Product (3y)230d

News(1)

  • GSK unveils 3-year cost-saving plan to fund late-stage R&D, move research HQ to AZ's backyard
    GSK has unveiled an ambitious three-year plan to divert resources to its late-stage R&D programs and shift its research headquarters—but CEO Luke Miels is being tight-lipped about the extent of any…
    fiercebiotech · 20d ago
brand
Dovato
generic
(dolutegravir sodium + lamivudine)
indication
Human Immunodeficiency Virus (HIV) Infections (AIDS)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 41m ago
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