Mesalamine
As of the edition of 20 October 2026, Mesalamine is a small molecule: marketed, first approved in 1984 (CH); acts on PPARG, PTGS1 and PTGS2; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Rowasa
- First approved
- 8 November 1984 (CH)
- Approvals on record
- 40 in 7 regions
- Holder of the most recent approval
- Mochida Pharmaceutical; 16 holders in all
- Registered trials
- 104, 15 stopped early
- Disease areas
- Digestive system; Immune system; Cancer; Nutrition and metabolism; Blood and lymph; Infections
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Viatris.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
12 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product12 company-target rows are on route B because of Mesalamine.
See the 12 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 6 | 1 | 2 |
| Phase 1 | 17 | 15 | 1 | 1 |
| Phase 2 | 17 | 11 | 4 | 2 |
| Phase 3 | 45 | 34 | 1 | 9 |
| Phase 4 | 14 | 9 | 1 | 1 |
| All trials | 104 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Medinova | Applicant | 1984 to now |
| Solvay Pharmaceuticals | Applicant | 1987 to now |
| Ferring Pharmaceuticals | Later holder and Lead sponsor of trials | 1989 to now |
| Procter And Gamble | Later holder | 1992 to now |
| Sanofi | Later holder | 1993 to now |
| Takeda | Later holder and Lead sponsor of trials | 1993 to now |
| AbbVie | Applicant, Acquired holder and Lead sponsor of trials | 1994 to now |
| Warner Chilcott | Later holder and Lead sponsor of trials | 2000 to now |
| Bausch Health | Later holder and Lead sponsor of trials | 2005 to now |
| Zeria Pharmaceutical | Applicant | 2009 to now |
| Viatris | Acquired holder | 2012 to now |
| Kyorin Pharmaceutical | Later holder | 2013 to now |
| Mochida Pharmaceutical | Later holder | 2016 to now |