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Last Updated: May 24, 2022

LIVALO Drug Patent 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 two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in seventeen 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.

Drug patent expirations by year for LIVALO
Drug Prices for LIVALO

See drug prices for LIVALO

Drug Sales Revenue Trends for LIVALO

See drug sales revenues for LIVALO

Recent Clinical Trials for LIVALO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AmgenPhase 4
Brigham and Women's HospitalPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Phase 3

See all LIVALO clinical trials

Paragraph IV (Patent) Challenges for LIVALO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LIVALO Tablets pitavastatin calcium 1 mg, 2 mg, and 4 mg 022363 7 2013-08-05

US Patents and Regulatory Information for LIVALO

LIVALO is protected by two US patents and two FDA Regulatory Exclusivities.

Patents protecting LIVALO

Hyperlipemia therapeutic agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of pitavastatin calcium
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting LIVALO

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 022363-001 Aug 3, 2009 See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 See Plans and Pricing See Plans and Pricing
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LIVALO

See the table below for patents covering LIVALO around the world.

Country Patent Number Title Estimated Expiration
Australia 2004212160 Crystalline forms of pitavastatin calcium See Plans and Pricing
China 101219992 Crystalline forms of pitavastatin calcium See Plans and Pricing
Spain 2067460 See Plans and Pricing
Japan 2014055185 NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM See Plans and Pricing
Poland 1715865 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
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Baxter
Harvard Business School
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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 verification 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.