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Last Updated: November 2, 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, Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in nine 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. Ten suppliers are listed for this compound.

Summary for pitavastatin calcium
Recent Clinical Trials for pitavastatin calcium

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

SponsorPhase
Sun Yat-sen UniversityPhase 4
Jun TaoPhase 4
Chungnam 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
Hetero Labs Ltd V PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205977-002 Apr 30, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206029-001 Nov 20, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Orient Pharma Co Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205932-002 Feb 3, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Ny PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205961-003 Aug 20, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-002 Feb 3, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ⤷  Sign Up ⤷  Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ⤷  Sign Up ⤷  Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ⤷  Sign Up ⤷  Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up
South Korea 20060109988 HYPERLIPEMIA THERAPEUTIC AGENT COMPRISING PITAVASTATINS AND EICOSAPENTAENOIC ACID ⤷  Sign Up
European Patent Office 1592668 FORMES CRISTALLINES DE CALCIUM DE PITAVASTATINE (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM) ⤷  Sign Up
Japan 2011201915 CRYSTALLINE FORM OF PITAVASTATIN CALCIUM ⤷  Sign Up
Japan 2014055185 NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM ⤷  Sign Up
>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.