Last Updated: June 22, 2026

PITAVASTATIN Drug Patent Profile

Name: PITAVASTATIN Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Pitavastatin, and what generic alternatives are available?

Pitavastatin is a drug marketed by Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in PITAVASTATIN is pitavastatin calcium. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pitavastatin

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

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Summary for PITAVASTATIN

US Patents:	0
Applicants:	8
NDAs:	8
Drug Prices:	Drug price information for PITAVASTATIN
DailyMed Link:	PITAVASTATIN at DailyMed

Drug patent expirations by year for PITAVASTATIN

US Patents and Regulatory Information for PITAVASTATIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205961-001	Aug 20, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Orient Pharma Co Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205932-003	Feb 3, 2017	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206047-003	Feb 22, 2023	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

DrugChatter Q&A for PITAVASTATIN

Pitavastatin calcium price?
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.