Pitavastatin calcium - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

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-two 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:	62
US Patents:	3
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	15
Suppliers / Packagers:	1
Bulk Api Vendors:	94
Clinical Trials:	2
Patent Applications:	7,294
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pitavastatin calcium
DailyMed Link:	pitavastatin calcium at DailyMed

Recent Clinical Trials for pitavastatin calcium

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

Sponsor	Phase
Sun Yat-sen University	Phase 4
Jun Tao	Phase 4
Ajou University School of Medicine	Phase 4

See all pitavastatin calcium clinical trials

Generic filers with tentative approvals for PITAVASTATIN CALCIUM

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	EQ 4MG BASE	TABLET;ORAL
Start Trial	Start Trial	EQ 2MG BASE	TABLET;ORAL
Start Trial	Start Trial	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	AB	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Mylan	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206070-001	Apr 4, 2019		DISCN	No	No	Start Trial	Start Trial				Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	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

Expired US Patents for pitavastatin calcium

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	Start Trial	Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	Start Trial	Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	Start Trial	Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	Start Trial	Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	Start Trial	Start Trial
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for pitavastatin calcium

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
Canada	1336714	Start Trial
Japan	2569746	Start Trial
Canada	2513837	Start Trial
Taiwan	201345893	Start Trial
China	101219992	Start Trial
Taiwan	201514149	Start Trial
>Country	>Patent Number	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.