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ASACOL Drug Profile

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

The generic ingredient in ASACOL is mesalamine. There are twenty-five drug master file entries for this compound. Twenty-one 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

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list6
Drug Prices: :see details

Pharmacology for Tradename: ASACOL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: ASACOL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992DISCNNo
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes9,089,492Nov 15, 2021Y
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008RXYes6,893,662Nov 15, 2021Y
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Expired Patents for Tradename: ASACOL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,170<disabled>
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 19925,541,171<disabled>
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Paragraph IV activity for: ASACOL

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Tablets800 mgAsacol HD7/13/2011
mesalamineDelayed-release Tablets400 mgAsacol6/22/2007
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