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Permitted DMARDs — Competitive Intelligence Brief

Permitted DMARDs (Permitted DMARDs) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Disease-Modifying Antirheumatic Drug (DMARD). Area: Immunology / Rheumatology.

phase 3 Disease-Modifying Antirheumatic Drug (DMARD) Immunology / Rheumatology Small molecule Live · refreshed every 30 min

Target snapshot

Permitted DMARDs (Permitted DMARDs) — Hoffmann-La Roche. DMARDs (Disease-Modifying Antirheumatic Drugs) suppress immune system activity to reduce inflammation and slow progression of autoimmune diseases.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Permitted DMARDs TARGET Permitted DMARDs Hoffmann-La Roche phase 3 Disease-Modifying Antirheumatic Drug (DMARD)
Leflunomide 10 milligram (MG) Leflunomide 10 milligram (MG) P. Verschueren marketed DHODH inhibitor; disease-modifying antirheumatic drug (DMARD) Dihydroorotate dehydrogenase (DHODH)
Methotrexate plus sulfasalazine Methotrexate plus sulfasalazine Singapore General Hospital marketed Disease-modifying antirheumatic drug (DMARD) combination Multiple (dihydrofolate reductase, folate metabolism; sulfapyridine and 5-ASA mechanisms)
Leflunomide plus Methotrexate Leflunomide plus Methotrexate Bangladesh Medical University marketed Disease-modifying antirheumatic drug (DMARD) combination Dihydroorotate dehydrogenase (leflunomide); Dihydrofolate reductase (methotrexate)
Placebo (PLA) + MTX, DB Placebo (PLA) + MTX, DB Bristol-Myers Squibb phase 3 Disease-modifying antirheumatic drug (DMARD) Dihydrofolate reductase (DHFR)
Methotrexate, Hydroxychloroquine Methotrexate, Hydroxychloroquine Sanjay Gandhi Postgraduate Institute of Medical Sciences phase 3 Immunosuppressive/Disease-modifying antirheumatic drug (DMARD) combination Dihydrofolate reductase (methotrexate); Toll-like receptors and lysosomal pH (hydroxychloroquine)
Leflunomide-Sulfasalazine-Hydroxychloroquine Leflunomide-Sulfasalazine-Hydroxychloroquine University of Nebraska phase 3 Disease-modifying antirheumatic drug (DMARD) combination Multiple targets: dihydroorotate dehydrogenase (leflunomide), NF-κB pathway (sulfasalazine), lysosomal function and TLR signaling (hydroxychloroquine)

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 (Disease-Modifying Antirheumatic Drug (DMARD) class)

  1. Hoffmann-La Roche · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Permitted DMARDs — Competitive Intelligence Brief. https://druglandscape.com/ci/permitted-dmards. Accessed 2026-05-14.

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