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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, Valeant Pharms Intl, 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

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Intl
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYes8,956,647<disabled>Y<disabled>
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXNo<disabled><disabled>
ENEMA;RECTAL076841-001Sep 30, 2004RXNo<disabled><disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992RXYes<disabled><disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes8,580,302<disabled>Y<disabled>
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International Patent Family for Ingredient: mesalamine

Country Document Number Publication Date
Germany60001835Nov 13, 2003
Hong Kong1085669Jul 31, 2009
Turkey200200561Jun 21, 2002
Germany19732903Feb 04, 1999
Germany60027608Jun 01, 2006
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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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