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mesalamine granules — Competitive Intelligence Brief

mesalamine granules (mesalamine granules) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: aminosalicylate. Area: Gastroenterology.

phase 3 aminosalicylate Gastroenterology Small molecule Live · refreshed every 30 min

Target snapshot

mesalamine granules (mesalamine granules) — Dr. Falk Pharma GmbH. Mesalamine works by releasing aminosalicylates in the colon to reduce inflammation and prevent symptoms of ulcerative colitis.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
mesalamine granules TARGET mesalamine granules Dr. Falk Pharma GmbH phase 3 aminosalicylate
Colazal BALSALAZIDE Valeant Pharms Intl marketed Aminosalicylate Prostaglandin G/H synthase 1 2000-01-01
Rowasa Mesalazine Meda Pharms marketed Aminosalicylate [EPC] Prostaglandin G/H synthase 2 1987-01-01
MESALAMINE MESALAMINE marketed Aminosalicylate [EPC] Cyclooxygenase 1987-01-01
Azulfidine En-Tabs SULFASALAZINE Pfizer marketed Aminosalicylate [EPC] Flavin reductase (NADPH) 1950-01-01
Tofacitinib plus mesalamine Tofacitinib plus mesalamine Post Graduate Institute of Medical Education and Research, Chandigarh marketed JAK inhibitor plus aminosalicylate JAK1/JAK3 (tofacitinib); unclear specific target for mesalamine (likely prostaglandin-related)
Azulfidine Sulfasalazine Pfizer Inc. marketed Sulfonamide; aminosalicylate 5-aminosalicylic acid (5-ASA) moiety; connective tissue affinity

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)

Sponsor landscape (aminosalicylate class)

  1. Dr. Falk Pharma GmbH · 1 drug in this class

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Cite this brief

Drug Landscape (2026). mesalamine granules — Competitive Intelligence Brief. https://druglandscape.com/ci/mesalamine-granules. Accessed 2026-06-10.

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