Delayed and extended release mesalazine — Competitive Intelligence Brief

Delayed and extended release mesalazine (Delayed and extended release mesalazine) competitive landscape: 2 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: 5-aminosalicylic acid (5-ASA) derivative. Area: Gastroenterology.

phase 3 5-aminosalicylic acid (5-ASA) derivative Gastroenterology Small molecule

Target snapshot

Delayed and extended release mesalazine (Delayed and extended release mesalazine) — Shire. Mesalazine (5-aminosalicylic acid) reduces intestinal inflammation by inhibiting prostaglandin and leukotriene production and scavenging reactive oxygen species in the colon.

Comparator set (2 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Delayed and extended release mesalazine TARGET	Delayed and extended release mesalazine	Shire	phase 3	5-aminosalicylic acid (5-ASA) derivative
Mesalazine tablets	Mesalazine tablets	AstraZeneca	phase 3	5-aminosalicylic acid (5-ASA) derivative	Prostaglandin and leukotriene synthesis inhibition; NF-κB pathway modulation
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