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Serving leading biopharmaceutical companies globally:

US Army
Colorcon
Covington
Merck
Farmers Insurance
Teva
McKinsey
Mallinckrodt
QuintilesIMS
McKesson

Generated: October 22, 2017

DrugPatentWatch Database Preview

LIVALO Drug Profile

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

Livalo is a drug marketed by Kowa Co and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in nineteen countries.

The generic ingredient in LIVALO is pitavastatin calcium. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pitavastatin calcium profile page.

Summary for Tradename: LIVALO

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list63
Clinical Trials: see list19
Patent Applications: see list3,669
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LIVALO at DailyMed

Pharmacology for Tradename: LIVALO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: LIVALO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for LIVALO

Drugname Dosage Strength RLD Submissiondate
pitavastatin calciumTablets1 mg, 2 mg, and 4 mgLivalo8/5/2013

Non-Orange Book Patents for Tradename: LIVALO

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
5,872,130 Quinoline type mevalonoactones► Subscribe
5,011,930 Quinoline type mevalonolactones► Subscribe
5,185,328 Quinoline type mevalonolactones useful for treating hyperlipidemia, hyperlipoproteinemia or atherosclerosis► Subscribe
5,854,259 Quinoline type mevalonolactones► Subscribe
7,776,881Hyperlipemia therapeutic agent► Subscribe
5,102,888 Quinoline type mevalonolactones useful for treating hyperlipidemia and related diseases► Subscribe
8,853,405Crystalline forms of pitavastatin calcium► 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: LIVALO

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005079797► Subscribe
South Korea20060109988► Subscribe
Japan2569746► Subscribe
Japan2013177466► Subscribe
TaiwanI485135► Subscribe
Canada2785954► Subscribe
China1747934► Subscribe
European Patent Office0304063► Subscribe
Japan2011201915► Subscribe
European Patent Office1715865► 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:

McKinsey
Boehringer Ingelheim
Deloitte
US Department of Justice
Merck
Dow
Covington
US Army
Healthtrust
Chinese Patent Office

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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