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Last Updated: July 12, 2020

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APRISO Drug Profile


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Which patents cover Apriso, and what generic alternatives are available?

Apriso is a drug marketed by Valeant Pharms Intl and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in thirteen countries.

The generic ingredient in APRISO is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

US ANDA Litigation and Generic Entry Outlook for Apriso

A generic version of APRISO was approved as mesalamine by PERRIGO ISRAEL on September 17th, 2004.

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Drug patent expirations by year for APRISO
Drug Prices for APRISO

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Drug Sales Revenue Trends for APRISO

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Recent Clinical Trials for APRISO

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SponsorPhase
Valeant Pharmaceuticals International, Inc.Phase 1
University of FloridaPhase 2

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Pharmacology for APRISO
Drug ClassAminosalicylate
Paragraph IV (Patent) Challenges for APRISO
Tradename Dosage Ingredient NDA Submissiondate
APRISO CAPSULE, EXTENDED RELEASE;ORAL mesalamine 022301 2012-04-03

US Patents and Regulatory Information for APRISO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for APRISO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008   Start Trial   Start Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008   Start Trial   Start Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Merck
Harvard Business School
Medtronic
Colorcon

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