Deep knowledge on
small-molecule drugs and
the 90,000 global patents
covering them

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

DrugPatentWatch Ultimate Plan Preview

Details for Generic Name: mesalamine

« Back to Dashboard
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, and Forest Labs Llc, and is included in eleven 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 seventy-six patent family members in twenty-four countries.

There are twenty-one 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

Drug Master File Entries: see list21
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

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
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 Llc
SUPPOSITORY;RECTAL021252-002Nov 5, 2004RXYes8,217,083<disabled>Y <disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992DISCNNo<disabled><disabled>
Warner Chilcott Llc
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013RXYes6,649,180<disabled>Y <disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: mesalamine

Country Document Number Publication Date
Austria241964Jun 15, 2003
Japan3716901Nov 16, 2005
Hong Kong1046247Apr 07, 2006
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

DrugPatentWatch Archives

You are viewing the current data set
Select a link below to view the archives:

 2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   2012   2013   2014  

For more information try a trial or see the database preview and plan comparison

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 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

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

Connect with Social Media:

Follow DrugPatentWatch on Twitter
Connect with DrugPatentWatch on Linkedin
Drug Patents on LinkedIn