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Profile for Tradename: ASACOL

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Asacol is a drug marketed by Warner Chilcott Llc and is included in two NDAs. It is available from seven suppliers. There are three patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ASACOL 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: ASACOL

Suppliers / Packagers: see list18

Pharmacology for Tradename: ASACOL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: ASACOL

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

Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Status: Completed Condition: Healthy

The Colitis Once Daily Asacol Study
Status: Completed Condition: Ulcerative Colitis

Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis
Status: Terminated Condition: Ulcerative Colitis

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Status: Recruiting Condition: Irritable Bowel Syndrome

Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis

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

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
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992DISCNNo<disabled><disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes9,089,492<disabled>Y <disabled>
Warner Chilcott Llc
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes6,893,662<disabled>Y <disabled>
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Paragraph IV activity for: ASACOL

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Tablets800mgAsacol HD7/13/2011
mesalamineDelayed-release Tablets400 mgAsacol6/22/2007
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Preferred citation:

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

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