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Last Updated: February 2, 2023

Pitavastatin calcium - Generic Drug Details


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What are the generic sources for pitavastatin calcium and what is the scope of patent protection?

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

Pitavastatin calcium has fifty-three patent family members in seventeen countries.

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

Recent Clinical Trials for pitavastatin calcium

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

SponsorPhase
Jun TaoPhase 4
Sun Yat-sen UniversityPhase 4
Chonbuk National University HospitalPhase 4

See all pitavastatin calcium clinical trials

Generic filers with tentative approvals for PITAVASTATIN CALCIUM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 4MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 2MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 1MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pitavastatin calcium
Paragraph IV (Patent) Challenges for PITAVASTATIN CALCIUM
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 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 205955-001 Feb 3, 2017 AB RX No 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
Mylan PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206070-001 Apr 4, 2019 DISCN No 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 Y 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 pitavastatin calcium

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

Country Patent Number Title Estimated Expiration
Japan 2014062115 NOVEL CRYSTALLINE FORM OF PITAVASTATIN CALCIUM See Plans and Pricing
European Patent Office 3299359 FORMES CRISTALLINES ET AMORPHE DU SEL HEMICALCIUM DE PITAVASTATIN (CRYSTALLINE AND AMORPHOUS FORMS OF PITAVASTATIN HEMICALCIUM SALT) See Plans and Pricing
Australia 2004212160 Crystalline forms of pitavastatin calcium See Plans and Pricing
Hong Kong 1098953 HYPERLIPEMIA THERAPEUTIC AGENT See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Boehringer Ingelheim
McKesson
Express Scripts
Harvard Business School

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.