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Dolutegravir + Lamivudine FDC — Competitive Intelligence Brief

Dolutegravir + Lamivudine FDC (Dolutegravir + Lamivudine FDC) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antiretroviral combination (INSTI + NRTI). Area: Infectious Disease / Virology.

phase 3 Antiretroviral combination (INSTI + NRTI) HIV integrase and HIV reverse transcriptase Infectious Disease / Virology Small molecule Live · refreshed every 30 min

Target snapshot

Dolutegravir + Lamivudine FDC (Dolutegravir + Lamivudine FDC) — ViiV Healthcare. Dolutegravir inhibits HIV integrase to prevent viral DNA integration into the host genome, while lamivudine inhibits reverse transcriptase to block viral replication.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Dolutegravir + Lamivudine FDC TARGET Dolutegravir + Lamivudine FDC ViiV Healthcare phase 3 Antiretroviral combination (INSTI + NRTI) HIV integrase and HIV reverse transcriptase
CAR CAR ViiV Healthcare marketed Antiretroviral combination therapy (INSTI + NNRTI) HIV integrase and HIV reverse transcriptase
JULUCA JULUCA ViiV Healthcare marketed Antiretroviral combination (integrase inhibitor + NNRTI) HIV integrase and HIV reverse transcriptase
Cabotegravir LA + Rilpivirine LA Cabotegravir LA + Rilpivirine LA Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia marketed Antiretroviral combination (INSTI + NNRTI) HIV integrase and HIV reverse transcriptase
CAB + RPV CAB + RPV Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) phase 3 Long-acting injectable antiretroviral combination (integrase inhibitor + non-nucleoside reverse transcriptase inhibitor) HIV integrase and HIV reverse transcriptase
CAB LA + RPV LA CAB LA + RPV LA ViiV Healthcare phase 3 Antiretroviral combination (integrase inhibitor + non-nucleoside reverse transcriptase inhibitor) HIV integrase and HIV reverse transcriptase
Cabotegravir, Rilpivirine Drug Combination Cabotegravir, Rilpivirine Drug Combination University Paris 7 - Denis Diderot phase 3 Antiretroviral combination (INSTI + NNRTI) HIV integrase and HIV reverse transcriptase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antiretroviral combination (INSTI + NRTI) class)

  1. ViiV Healthcare · 2 drugs in this class
  2. Denver Infectious Disease Consultants, PLLC · 1 drug in this class
  3. Fundacion SEIMC-GESIDA · 1 drug in this class
  4. Fundação Bahiana de Infectologia · 1 drug in this class
  5. Charlotte-Paige Rolle, MD · 1 drug in this class
  6. Saint Michael's Medical Center · 1 drug in this class
  7. The University of Texas Health Science Center, Houston · 1 drug in this class
  8. Hospitales Universitarios Virgen del Rocío · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Dolutegravir + Lamivudine FDC — Competitive Intelligence Brief. https://druglandscape.com/ci/dolutegravir-lamivudine-fdc. Accessed 2026-05-17.

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