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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Harvard Business School
Johnson and Johnson
Argus Health
McKinsey
AstraZeneca
Baxter
Farmers Insurance
Moodys

Generated: December 17, 2017

DrugPatentWatch Database Preview

LIVALO Drug Profile

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When do Livalo patents expire, 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.

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
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: LIVALO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-003Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-001Aug 3, 2009► Subscribe► Subscribe
Kowa CoLIVALOpitavastatin calciumTABLET;ORAL022363-002Aug 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
8,853,405Crystalline forms of pitavastatin calcium► Subscribe
5,011,930 Quinoline type mevalonolactones► Subscribe
7,776,881Hyperlipemia therapeutic agent► Subscribe
5,854,259 Quinoline type mevalonolactones► Subscribe
5,872,130 Quinoline type mevalonoactones► Subscribe
5,185,328 Quinoline type mevalonolactones useful for treating hyperlipidemia, hyperlipoproteinemia or atherosclerosis► Subscribe
5,102,888 Quinoline type mevalonolactones useful for treating hyperlipidemia and related diseases► 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
Japan5366163► Subscribe
European Patent Office2500339► Subscribe
Japan2014062115► Subscribe
Poland376557► Subscribe
Japan2014024848► Subscribe
Slovenia1715865► Subscribe
Canada2513837► Subscribe
Canada2785954► Subscribe
Australia2004212160► Subscribe
Taiwan201213311► 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:

Cantor Fitzgerald
Baxter
Julphar
Covington
McKesson
Medtronic
Farmers Insurance
Express Scripts
Teva
US Army

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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