Mesalazine tablets — Competitive Intelligence Brief

Mesalazine tablets (Mesalazine tablets) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: 5-aminosalicylic acid (5-ASA) derivative. Area: Gastroenterology / Immunology.

phase 3 5-aminosalicylic acid (5-ASA) derivative Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation Gastroenterology / Immunology Small molecule

Target snapshot

Mesalazine tablets (Mesalazine tablets) — AstraZeneca. Mesalazine reduces inflammation in the colon and rectum by inhibiting prostaglandin and leukotriene production, thereby suppressing inflammatory mediators.

Comparator set (3 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Mesalazine tablets TARGET	Mesalazine tablets	AstraZeneca	phase 3	5-aminosalicylic acid (5-ASA) derivative	Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation
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
Delayed and extended release mesalazine	Delayed and extended release mesalazine	Shire	phase 3	5-aminosalicylic acid (5-ASA) derivative
mesalazine (Asacol®)	mesalazine (Asacol®)	Cardiff and Vale University Health Board	phase 3	5-aminosalicylic acid (5-ASA) derivative	Nuclear factor-kappa B (NF-κB); prostaglandin and leukotriene pathways

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

1. AstraZeneca · 1 drug in this class
2. Cardiff and Vale University Health Board · 1 drug in this class
3. Shire · 1 drug in this class