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Pitavastatin calcium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for pitavastatin calcium?

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.

This ingredient has fifty-five patent family members in nineteen countries.

There are thirteen drug master file entries for pitavastatin calcium. Two suppliers are listed for this compound.

Summary for Generic Name: pitavastatin calcium

Tradenames:2
Patents:5
Applicants:4
NDAs:4
Drug Master File Entries: see list13
Suppliers / Packagers: see list2
Bulk Api Vendors: see list72
Clinical Trials: see list753
Patent Applications: see list3,482
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sawai Usa
PITAVASTATIN CALCIUM
pitavastatin calcium
TABLET;ORAL205955-001Feb 3, 2017RXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
PITAVASTATIN CALCIUM
pitavastatin calcium
TABLET;ORAL206015-002Dec 20, 2016RXNoNo► Subscribe► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 2009RXYesNo5,856,336► SubscribeY ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009RXYesYes7,022,713► Subscribe ► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 2009RXYesYes5,856,336► 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;ORAL022363-001Aug 3, 20095,753,675► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-001Aug 3, 20095,854,259► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 20095,854,259► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-003Aug 3, 20095,753,675► Subscribe
Kowa Co
LIVALO
pitavastatin calcium
TABLET;ORAL022363-002Aug 3, 20096,465,477► 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
8,853,405Crystalline forms of pitavastatin calcium► 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
5,011,930 Quinoline type mevalonolactones► Subscribe
5,854,259 Quinoline type mevalonolactones► 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
Canada2785954► Subscribe
Taiwan200420541► Subscribe
Japan5192147► Subscribe
TaiwanI485135► Subscribe
Taiwan201345893► 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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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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