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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-six 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: DELZICOL

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list112
Clinical Trials: see list1
Patent Applications: see list8,045
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:DELZICOL at DailyMed

Pharmacology for Tradename: DELZICOL

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013RXYesYes6,649,180► subscribeY ► subscribe
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Expired Patents for Tradename: DELZICOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,170► subscribe
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 20135,541,171► subscribe
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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► subscribe
Spain2191595► subscribe
Japan2000297102► subscribe
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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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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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