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DELZICOL Drug Profile

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Delzicol is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in five countries.

The generic ingredient in DELZICOL 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: DELZICOL

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

Pharmacology for Tradename: DELZICOL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Clinical Trials for: DELZICOL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013RXYes6,649,180<disabled>Y <disabled>
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Expired Patents for Tradename: DELZICOL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,170<disabled>
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,171<disabled>
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Paragraph IV activity for: DELZICOL

Drugname Dosage Strength RLD Submissiondate
mesalamineDelayed-release Capsules400 mgDelzicol6/17/2014

International Patent Family for Tradename: DELZICOL

Country Document Number Estimated Expiration
South Korea20010014728<disabled in preview>
South Korea100536084<disabled in preview>
Japan2000297102<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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