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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-one 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 list21
Suppliers / Packaging: see list53
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: mesalamine

Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis

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

Courtesy of ClinicalTrials.org
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
Shire
LIALDA
mesalamine
TABLET, DELAYED RELEASE;ORAL022000-001Jan 16, 2007RXYes6,773,720<disabled>Y<disabled>
Meda Pharms
ROWASA
mesalamine
SUPPOSITORY;RECTAL019919-001Dec 18, 1990DISCNNo<disabled><disabled>
Forest Labs Inc
CANASA
mesalamine
SUPPOSITORY;RECTAL021252-001Jan 5, 2001DISCNNo<disabled><disabled>
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXNo<disabled><disabled>
Warner Chilcott Llc
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992RXYes<disabled><disabled>
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International Patent Family for Ingredient: mesalamine

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2011084638Jul 14, 2011
China102238868Nov 09, 2011
Israel220397Aug 30, 2012
Germany59808642Jul 10, 2003
Canada2297832Sep 18, 2007
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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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