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Last Updated: June 27, 2022

APRISO Drug Patent 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. Thirty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Apriso

A generic version of APRISO was approved as mesalamine by PADAGIS 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bausch Health Americas, Inc.Phase 1
Valeant Pharmaceuticals International, Inc.Phase 1
University of MichiganN/A

See all APRISO clinical trials

Pharmacology for APRISO
Drug ClassAminosalicylate
Paragraph IV (Patent) Challenges for APRISO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
APRISO Extended-release Capsules mesalamine 0.375 g 022301 1 2012-04-03

US Patents and Regulatory Information for APRISO

APRISO is protected by one US patents.

Patents protecting APRISO

Compositions and methods for treatment of bowel diseases with granulated mesalamine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS

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

International Patents for APRISO

See the table below for patents covering APRISO around the world.

Country Patent Number Title Estimated Expiration
Canada 2297832 FORMULATION DE TYPE PELLET, S'UTILISANT DANS LE TRAITEMENT DU TRACTUS INTESTINAL (PELLET-TYPE FORMULATION INTENDED FOR TREATING THE INTESTINALTRACT) See Plans and Pricing
Australia 2009298139 Compositions and methods for the treatment of bowel diseases with granulated mesalamine See Plans and Pricing
New Zealand 592049 COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE See Plans and Pricing
Portugal 977557 See Plans and Pricing
Germany 59808642 See Plans and Pricing
Eurasian Patent Organization 201100565 КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ КИШЕЧНИКА С ИСПОЛЬЗОВАНИЕМ ГРАНУЛИРОВАННОГО МЕЗАЛАМИНА See Plans and Pricing
Japan 4088413 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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