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, Mylan, Orient Pharma Co Ltd, and Sawai Usa, and is included in five 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. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for pitavastatin calcium

International Patents:	53
US Patents:	2
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Patent Applications:	7,001
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
Chonbuk National University Hospital	Phase 4

See all pitavastatin calcium clinical trials

Generic filers with tentative approvals for PITAVASTATIN CALCIUM

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	EQ 4MG BASE	TABLET;ORAL
See Plans and Pricing	See Plans and Pricing	EQ 2MG BASE	TABLET;ORAL
See Plans and Pricing	See Plans and Pricing	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	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

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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
Sawai Usa	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205955-001	Feb 3, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mylan	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206070-001	Apr 4, 2019		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing			Y	See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	See Plans and Pricing	See Plans and Pricing
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	See Plans and Pricing	See Plans and Pricing
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for pitavastatin calcium

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Country	Patent Number	Title	Estimated Expiration
Japan	2014062115	NOVEL CRYSTALLINE FORM OF PITAVASTATIN CALCIUM	See Plans and Pricing
European Patent Office	3299359	FORMES CRISTALLINES ET AMORPHE DU SEL HEMICALCIUM DE PITAVASTATIN (CRYSTALLINE AND AMORPHOUS FORMS OF PITAVASTATIN HEMICALCIUM SALT)	See Plans and Pricing
Australia	2004212160	Crystalline forms of pitavastatin calcium	See Plans and Pricing
Hong Kong	1098953	HYPERLIPEMIA THERAPEUTIC AGENT	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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