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Last Updated: March 29, 2024

Pitavastatin calcium - Generic Drug Details


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What are the generic drug sources for pitavastatin calcium and what is the scope of freedom to operate?

Pitavastatin calcium is the generic ingredient in two branded drugs marketed by Kowa Co, Aurobindo Pharma, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in seven 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. Eight suppliers are listed 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
Chonnam National University HospitalPhase 4

See all pitavastatin calcium clinical trials

Pharmacology for pitavastatin calcium
Anatomical Therapeutic Chemical (ATC) Classes 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
Mylan PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206070-002 Apr 4, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-001 Feb 3, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206029-002 Nov 20, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206015-003 Dec 20, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206047-003 Feb 22, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206070-003 Apr 4, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 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 ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for pitavastatin calcium

Country Patent Number Title Estimated Expiration
Japan 5474276 ⤷  Try a Trial
European Patent Office 1592668 FORMES CRISTALLINES DE CALCIUM DE PITAVASTATINE (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) ⤷  Try a Trial
Slovenia 1715865 ⤷  Try a Trial
China 101219992 Crystalline forms of pitavastatin calcium ⤷  Try a Trial
Spain 2342609 ⤷  Try a Trial
Japan 5366163 ⤷  Try a Trial
Japan 2014055185 NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.