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Details for Generic Name: mesalamine

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Mesalamine is the generic ingredient in ten branded drugs marketed by Warner Chilcott Llc, Salix Pharms, Shire, Perrigo Israel, Teva, Meda Pharms, and Forest Labs Inc, and is included in eleven NDAs. There are thirteen patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for mesalamine. Fifteen suppliers are listed for this compound.

Summary for Generic Name: mesalamine

Drug Master File Entries: see list20
Suppliers: see list15
Therapeutic Class:Inflammatory Bowel Disease Agents

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: mesalamine

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Status: Recruiting Condition: Irritable Bowel Syndrome

Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
Status: Completed Condition: Irritable Bowel Syndrome

Cimzia Versus Mesalamine for Crohn's Recurrence
Status: Recruiting Condition: Crohn's Disease

Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Inc
SUPPOSITORY;RECTAL021252Jan 5, 2001DISCNNo<disabled><disabled>
Salix Pharms
CAPSULE, EXTENDED RELEASE;ORAL022301Oct 31, 2008RXYes8,865,688<disabled><disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL021830May 29, 2008RXYes6,893,662<disabled>Y<disabled>
Salix Pharms
CAPSULE, EXTENDED RELEASE;ORAL022301Oct 31, 2008RXYes8,337,886<disabled>Y<disabled>
Warner Chilcott Llc
CAPSULE, DELAYED RELEASE;ORAL204412Feb 1, 2013RXYes5,541,170<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:
Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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