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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 fourteen patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-four patent family members in twenty-three countries.

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

Summary for Generic Name: mesalamine

Tradenames:10
Patents:14
Applicants:7
NDAs:11
Drug Master File Entries: see list20
Suppliers: see list15
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

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

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Inc
CANASA
mesalamine
SUPPOSITORY;RECTAL021252-001Jan 5, 2001DISCNNo<disabled><disabled>
Meda Pharms
SFROWASA
mesalamine
ENEMA;RECTAL019618-002Jun 20, 2008RXNo7,645,801<disabled>YY<disabled>
Shire
LIALDA
mesalamine
TABLET, DELAYED RELEASE;ORAL022000-001Jan 16, 2007RXYes6,773,720<disabled>Y<disabled>
Salix Pharms
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYes8,911,778<disabled>Y<disabled>
Warner Chilcott Llc
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013RXYes6,649,180<disabled>Y<disabled>
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International Patent Family for Ingredient: mesalamine

Country Document Number Publication Date
Japan4727875Jul 20, 2011
Spain2191595Sep 16, 2003
Japan2000297102Oct 24, 2000
Austria241964Jun 15, 2003
Mexico2012006902Oct 05, 2012
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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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