Last reviewed · How we verify
mesalamine granules — Competitive Intelligence Brief
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)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / 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)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
- — Rowasa · 7645801 · US
- — MESALAMINE · 7645801 · Compound · US
- — Rowasa · 8217083 · US
- — MESALAMINE · 8436051 · Formulation · US
- — Rowasa · 8436051 · US
- — MESALAMINE · 8217083 · Formulation · US
- — Rowasa · 8865688 · US
- — MESALAMINE · 8865688 · Method of Use · US
Sponsor landscape (aminosalicylate class)
- 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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