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Last Updated: September 25, 2020

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PITAVASTATIN CALCIUM Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Pitavastatin Calcium

A generic version of PITAVASTATIN CALCIUM was approved as pitavastatin calcium by AUROBINDO PHARMA LTD on December 20th, 2016.

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Drug patent expirations by year for PITAVASTATIN CALCIUM
Recent Clinical Trials for PITAVASTATIN CALCIUM

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

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Paragraph IV (Patent) Challenges for PITAVASTATIN CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
LIVALO TABLET;ORAL pitavastatin calcium 022363 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
Aurobindo Pharma Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206015-001 Dec 20, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Orient Pharma Co Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205932-001 Feb 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206070-001 Apr 4, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Sawai Usa PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205955-003 Feb 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Orient Pharma Co Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 205932-002 Feb 3, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKinsey
Moodys
Baxter
Merck

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