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Last Updated: March 28, 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 patent protection?

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
Sun Yat-sen UniversityPhase 4
Jun TaoPhase 4
Asan Medical CenterPhase 4

See all pitavastatin calcium clinical trials

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 205955-002 Feb 3, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206047-002 Feb 22, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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