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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Federal Trade Commission
UBS
Dow
Deloitte
Mallinckrodt
Argus Health
Fuji
Teva

Generated: December 18, 2017

DrugPatentWatch Database Preview

APRISO Drug Profile

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When do Apriso patents expire, 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 suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Drug patent expirations by year for APRISO

Pharmacology for APRISO

Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate

Medical Subject Heading (MeSH) Categories for APRISO

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, EXTENDED RELEASE;ORAL022301-001Oct 31, 2008RXYesYes► Subscribe► SubscribeYY► Subscribe
Valeant Pharms IntlAPRISOmesalamineCAPSULE, 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
Eurasian Patent Organization201100565► Subscribe
Japan2001511441► Subscribe
Israel212057► Subscribe
New Zealand592049► Subscribe
Canada2739465► Subscribe
Japan2012504658► Subscribe
Germany19732903► Subscribe
Japan4088413► Subscribe
Portugal977557► Subscribe
China102238868► 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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Serving leading biopharmaceutical companies globally:

Queensland Health
Covington
QuintilesIMS
Teva
Moodys
US Department of Justice
Johnson and Johnson
Fuji
McKesson
Fish and Richardson

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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