Granulated mesalamine — Competitive Intelligence Brief

Granulated mesalamine (Granulated mesalamine) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: 5-aminosalicylic acid (5-ASA) agent. Area: Gastroenterology / Immunology.

phase 3 5-aminosalicylic acid (5-ASA) agent Prostaglandin and leukotriene synthesis inhibition Gastroenterology / Immunology Small molecule

Target snapshot

Granulated mesalamine (Granulated mesalamine) — Bausch Health Americas, Inc.. Mesalamine is an anti-inflammatory agent that acts locally in the colon to reduce inflammation by inhibiting prostaglandin and leukotriene production.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Granulated mesalamine TARGET	Granulated mesalamine	Bausch Health Americas, Inc.	phase 3	5-aminosalicylic acid (5-ASA) agent	Prostaglandin and leukotriene synthesis inhibition
Asacol (mesalamine)	Asacol (mesalamine)	University of Washington	marketed	5-aminosalicylic acid (5-ASA) agent	Prostaglandin and leukotriene synthesis inhibition; free radical scavenging
sulphasalazine (SSZ)	sulphasalazine (SSZ)	Wyeth is now a wholly owned subsidiary of Pfizer	marketed	5-aminosalicylic acid (5-ASA) agent	Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation
Mesalazine tablets	Mesalazine tablets	AstraZeneca	phase 3	5-aminosalicylic acid (5-ASA) derivative	Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation
Mesalazine(asacol 800 mg)	Mesalazine(asacol 800 mg)	Tehran University of Medical Sciences	marketed	5-aminosalicylic acid (5-ASA) agent	Prostaglandin and leukotriene synthesis; nuclear factor-kappa B (NF-κB) pathway
MMX mesalamine/ mesalazine	MMX mesalamine/ mesalazine	Shire	marketed	5-aminosalicylic acid (5-ASA) agent	Prostaglandin and leukotriene synthesis; non-selective anti-inflammatory mechanism
MMX Mesalamine	MMX Mesalamine	Shire	marketed	5-aminosalicylic acid (5-ASA) agent	Prostaglandin and leukotriene pathways (topical anti-inflammatory)

Recent regulatory actions (last 90 days)

• 2026-03-31 — Asacol (mesalamine) · FDA · approved · US · University of Washington

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 (5-aminosalicylic acid (5-ASA) agent class)

1. Shire · 2 drugs in this class
2. Bausch Health Americas, Inc. · 1 drug in this class
3. Tehran University of Medical Sciences · 1 drug in this class
4. University of Washington · 1 drug in this class
5. Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class