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Profile for Tradename: ASACOL HD

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Asacol Hd is a drug marketed by Warner Chilcott Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventeen patent family members in seventeen countries.

The generic ingredient in ASACOL HD 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: ASACOL HD

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: ASACOL HD

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: ASACOL HD

Courtesy of ClinicalTrials.org
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes6,893,662<disabled>Y <disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes8,580,302<disabled>Y <disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes9,089,492<disabled>Y <disabled>
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Expired Patents for Tradename: ASACOL HD

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 20085,541,170<disabled>
Warner Chilcott Llc
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 20085,541,171<disabled>
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Paragraph IV activity for: ASACOL HD

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Tablets800mgAsacol HD7/13/2011

International Patent Family for Tradename: ASACOL HD

Country Document Number Publication Date
Israel161628Mar 31, 2014
Peru05292002Jul 18, 2002
New Zealand532564Jun 30, 2006
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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.

Copyright 2002-2016 thinkBiotech LLC
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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