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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, G And W Labs Inc, Perrigo Israel, Meda Pharms, Forest Labs Llc, and Mylan Pharms Inc, and is included in twelve NDAs. There are fifteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-one patent family members in twenty-six countries.

There are twenty-two drug master file entries for mesalamine. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: mesalamine

Tradenames:10
Patents:15
Applicants:8
NDAs:12
Drug Master File Entries: see list22
Suppliers / Packaging: see list54
Therapeutic Class:Inflammatory Bowel Disease Agents

Pharmacology for Ingredient: mesalamine

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Tentative approvals for MESALAMINE

Applicant Application No. Form Dosage
<disabled><disabled>SUPPOSITORY;RECTAL1000MG

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

Predicting Response to Standardized Pediatric Colitis Therapy
Status: Active, not recruiting Condition: Ulcerative Colitis

Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC)
Status: Completed Condition: Colitis, Ulcerative; Recurrence

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
Meda Pharms
SFROWASA
mesalamine
ENEMA;RECTAL019618-002Jun 20, 2008RXNo7,645,801<disabled>YY <disabled>
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXNo<disabled><disabled>
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYes8,337,886<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: mesalamine

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott Llc
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,170<disabled>
Warner Chilcott Llc
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,171<disabled>
Warner Chilcott Llc
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,170<disabled>
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International Patent Family for Ingredient: mesalamine

Country Document Number Publication Date
Denmark1453487Jul 21, 2008
Israel161628Mar 31, 2014
Hungary0402230Apr 28, 2008
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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