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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Federal Trade Commission
Covington
McKinsey
Merck
US Army
Fish and Richardson
QuintilesIMS
McKesson
Colorcon

Generated: January 22, 2018

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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 Kowa Co, Aurobindo Pharma Ltd, Orient Pharma Co Ltd, and Sawai Usa, 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 fourteen drug master file entries for pitavastatin calcium. Two suppliers are listed for this compound.
Pharmacology for pitavastatin calcium

US Patents and Regulatory Information for pitavastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-002 Feb 3, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206015-003 Dec 20, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orient Pharma Co Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205932-003 Feb 3, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206015-002 Dec 20, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-001 Feb 3, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for pitavastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,853,405 Crystalline forms of pitavastatin calcium ➤ Subscribe
5,872,130 Quinoline type mevalonoactones ➤ Subscribe
5,185,328 Quinoline type mevalonolactones useful for treating hyperlipidemia, hyperlipoproteinemia or atherosclerosis ➤ Subscribe
5,854,259 Quinoline type mevalonolactones ➤ Subscribe
7,776,881 Hyperlipemia therapeutic agent ➤ Subscribe
5,011,930 Quinoline type mevalonolactones ➤ Subscribe
5,102,888 Quinoline type mevalonolactones useful for treating hyperlipidemia and related diseases ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for pitavastatin calcium

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
US Army
Medtronic
Citi
Mallinckrodt
Julphar
Teva
Farmers Insurance

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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