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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-two 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: PENTASA

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list10

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

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

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: Recruiting Condition: Ulcerative Colitis

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

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

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
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 1993RXNo<disabled><disabled>
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-002Jul 8, 2004RXYes<disabled><disabled>
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Expired Patents for Tradename: PENTASA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,496,553<disabled>
Shire
PENTASA
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL020049-001May 10, 19934,980,173<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.

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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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