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Last Updated: July 2, 2020

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in nineteen countries.

The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen 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 ANDA Litigation and Generic Entry Outlook for Livalo

A generic version of LIVALO was approved as pitavastatin calcium by AUROBINDO PHARMA LTD on December 20th, 2016.

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Drug patent expirations by year for LIVALO
Drug Prices for LIVALO

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Drug Sales Revenue Trends for LIVALO

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Recent Clinical Trials for LIVALO

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SponsorPhase
New England Research InstitutesPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Phase 4
Kowa Research Institute, Inc.Phase 3

See all LIVALO clinical trials

Pharmacology for LIVALO
Paragraph IV (Patent) Challenges for LIVALO
Tradename Dosage Ingredient NDA Submissiondate
LIVALO TABLET;ORAL pitavastatin calcium 022363 2013-08-05

US Patents and Regulatory Information for 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;ORAL 022363-001 Aug 3, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 AB RX Yes No   Start Trial   Start Trial   Start Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LIVALO

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Baxter
Harvard Business School
McKesson

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