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Profile for Tradename: PENTASA

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Pentasa is a drug marketed by Shire and is included in one NDA. It is available from five suppliers.

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

Summary for Tradename: PENTASA

Patents:2
Applicants:1
NDAs:1
Suppliers: see list5

Pharmacology for Tradename: PENTASA

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: PENTASA

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

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active 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

Predicting Response to Standardized Pediatric Colitis Therapy
Status: Recruiting Condition: Ulcerative Colitis

Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
Status: Completed Condition: Irritable Bowel Syndrome

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase
Status: Not yet recruiting Condition: Ulcerative Colitis

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

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

Correlation of Mesalamine Pharmacokinetics With Local Availability
Status: Active, not recruiting Condition: Local Drug Concentration in Gastrointestinal Tract

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Exclusivity Expiration
Shire Labs
PENTASA
mesalamine
Capsule, Extended Release; Oral020049-001MAY 10, 1993RXYes4,496,553<disabled><disabled>
Shire Labs
PENTASA
mesalamine
Capsule, Extended Release; Oral020049-001MAY 10, 1993RXYes4,980,173<disabled><disabled>
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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.

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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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