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Last Updated: October 27, 2021

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Pitavastatin calcium - Generic Drug Details

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What are the generic 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 Ltd, Mylan, Orient Pharma Co Ltd, and Sawai Usa, and is included in five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pitavastatin calcium has sixty-three patent family members in nineteen countries.

There are fifteen drug master file entries for pitavastatin calcium. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for pitavastatin calcium

International Patents:	63
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	2
Patent Applications:	7,400
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pitavastatin calcium
What excipients (inactive ingredients) are in pitavastatin calcium?	pitavastatin calcium excipients list
DailyMed Link:	pitavastatin calcium at DailyMed

Recent Clinical Trials for pitavastatin calcium

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

Sponsor	Phase
Jun Tao	Phase 4
Sun Yat-sen University	Phase 4
Gangnam Severance Hospital	Phase 4

See all pitavastatin calcium clinical trials

Generic filers with tentative approvals for PITAVASTATIN CALCIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Try it Free	⤷ Try it Free	EQ 4MG BASE	TABLET;ORAL
⤷ Try it Free	⤷ Try it Free	EQ 2MG BASE	TABLET;ORAL
⤷ Try it Free	⤷ Try it Free	EQ 1MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pitavastatin calcium

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

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Glossary

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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
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No	⤷ Try it Free	⤷ Try it Free			Y	⤷ Try it Free
Mylan	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206070-003	Apr 4, 2019		DISCN	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free			Y	⤷ Try it Free
Orient Pharma Co Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205932-001	Feb 3, 2017	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Try it Free	⤷ Try it Free
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	⤷ Try it Free	⤷ Try it Free
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	⤷ Try it Free	⤷ Try it Free
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for pitavastatin calcium

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Country	Patent Number	Estimated Expiration
Germany	202004021379	⤷ Try it Free
Australia	2004212160	⤷ Try it Free
Canada	2513837	⤷ Try it Free
World Intellectual Property Organization (WIPO)	2005079797	⤷ Try it Free
>Country	>Patent Number	>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.