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Profile for Tradename: DELZICOL

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Delzicol is a drug marketed by Warner Chilcott Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in DELZICOL is mesalamine. There are twenty-one drug master file entries for this compound. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mesalamine profile page.

Summary for Tradename: DELZICOL

Suppliers / Packagers: see list2

Pharmacology for Tradename: DELZICOL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: DELZICOL

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

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
Status: Completed Condition: Crohn's Disease

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.
Status: Completed Condition: Ulcerative Colitis

Canadian Active & Maintenance Modified Pentasa Study
Status: Completed Condition: Active Ulcerative Colitis; Remission of 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

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

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

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
Warner Chilcott Llc
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013RXYes6,649,180<disabled>Y <disabled>
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Paragraph IV activity for: DELZICOL

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Capsules400 mgDelzicol6/17/2014

International Patent Family for Tradename: DELZICOL

Country Document Number Publication Date
Germany60001283Mar 06, 2003
Japan3716901Nov 16, 2005
South Korea100536084Dec 12, 2005
Spain2191595Sep 16, 2003
European Patent Office1045000Oct 18, 2000
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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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