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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Chubb
Baxter
Cantor Fitzgerald
Cerilliant
Chinese Patent Office
Accenture
Teva
Medtronic

Generated: October 22, 2017

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Pitavastatin calcium - Generic Drug Details

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What are the generic sources for pitavastatin calcium and what is the scope of pitavastatin calcium freedom to operate?

Pitavastatin calcium
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Orient Pharma Co Ltd, Sawai Usa, and Kowa Co, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pitavastatin calcium has fifty-eight patent family members in nineteen countries.

There are thirteen drug master file entries for pitavastatin calcium. One supplier is listed for this compound.

Summary for Generic Name: pitavastatin calcium

US Patents:4
Tradenames:2
Applicants:4
NDAs:4
Drug Master File Entries: see list13
Suppliers / Packagers: see list1
Bulk Api Vendors: see list72
Clinical Trials: see list1,844
Patent Applications: see list6,014
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pitavastatin calcium at DailyMed

Pharmacology for Ingredient: pitavastatin calcium

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► Subscribe ► Subscribe
Orient Pharma Co Ltd
PITAVASTATIN CALCIUM
pitavastatin calcium
TABLET;ORAL205932-002Feb 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Aurobindo Pharma Ltd
PITAVASTATIN CALCIUM
pitavastatin calcium
TABLET;ORAL206015-002Dec 20, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sawai Usa
PITAVASTATIN CALCIUM
pitavastatin calcium
TABLET;ORAL205955-002Feb 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Orient Pharma Co Ltd
PITAVASTATIN CALCIUM
pitavastatin calcium
TABLET;ORAL205932-003Feb 3, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 2009ABRXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pitavastatin calcium

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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Non-Orange Book Patents for Generic Ingredient: pitavastatin calcium

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 Ingredient: pitavastatin calcium

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:

Moodys
Federal Trade Commission
Boehringer Ingelheim
Queensland Health
Cipla
QuintilesIMS
Farmers Insurance
Cantor Fitzgerald
Cerilliant
Chubb

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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