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Serving leading biopharmaceutical companies globally:

Cipla
AstraZeneca
Cerilliant
Citi
Argus Health
Novartis
Farmers Insurance
Cantor Fitzgerald
Julphar
Accenture

Generated: October 16, 2017

DrugPatentWatch Database Preview

APRISO Drug Profile

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What is the patent landscape for Apriso, and when can generic versions of Apriso launch?

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

This drug has twenty-six patent family members in seventeen countries.

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

Summary for Tradename: APRISO

US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list112
Clinical Trials: see list1
Patent Applications: see list6,010
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:APRISO at DailyMed

Pharmacology for Tradename: APRISO

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate
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;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeYY ► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Valeant Pharms Intl
APRISO
mesalamine
CAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for APRISO

Drugname Dosage Strength RLD Submissiondate
mesalamineExtended-release Capsules0.375 gApriso4/3/2012

Premature patent expiration for: APRISO

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
► Subscribe
APRISO
► Subscribe

Non-Orange Book Patents for Tradename: APRISO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,277,412 Pellet-type formulation intended for treating the intestinal tract► Subscribe
7,547,451Pellet formulation for the treatment of the intestinal tract► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: APRISO

Country Document Number Estimated Expiration
Australia2009298139► Subscribe
World Intellectual Property Organization (WIPO)9906027► Subscribe
Germany19732903► Subscribe
Austria241964► Subscribe
Canada2739465► Subscribe
Mexico2011003595► Subscribe
Germany59808642► Subscribe
Eurasian Patent Organization022886► Subscribe
Japan2012504658► Subscribe
Spain2196556► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
US Department of Justice
McKinsey
Daiichi Sankyo
Boehringer Ingelheim
Accenture
Novartis
UBS
Citi
Cipla

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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