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ASACOL HD Drug Profile

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Asacol Hd is a drug marketed by Apil and is included in one NDA. It is available from two suppliers. 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-five drug master file entries for this compound. Eighteen 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 list2

Pharmacology for Tradename: ASACOL HD

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: ASACOL HD

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes6,893,662<disabled>Y <disabled>
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes8,580,302<disabled>Y <disabled>
Apil
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
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 20085,541,170<disabled>
Apil
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 Tablets800 mgAsacol HD7/13/2011

International Patent Family for Tradename: ASACOL HD

Country Document Number Estimated Expiration
Portugal1453487<disabled in preview>
Spain2301575<disabled in preview>
Austria389389<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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