Pitavastatin calcium - Generic Drug Details

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What are the generic drug sources for pitavastatin calcium and what is the scope of freedom to operate?

Pitavastatin calcium is the generic ingredient in two branded drugs marketed by Kowa Co, Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in nine 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. Ten suppliers are listed for this compound.

Summary for pitavastatin calcium

International Patents:	53
US Patents:	2
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	2
Patent Applications:	7,177
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
Sun Yat-sen University	Phase 4
Jun Tao	Phase 4
Hanllym University Medical Center	Phase 4

See all pitavastatin calcium clinical trials

Pharmacology for pitavastatin calcium

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

Anatomical Therapeutic Chemical (ATC) Classes for pitavastatin calcium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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
Aurobindo Pharma	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206015-001	Dec 20, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205961-003	Aug 20, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Amneal Pharms Ny	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205961-002	Aug 20, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Mylan	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206070-001	Apr 4, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Orient Pharma Co Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205932-001	Feb 3, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	022363-003	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	⤷ Sign Up	⤷ Sign Up
>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	2014205723	ピタバスタチンカルシウムの新規な結晶質形態 (NEW CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM)	⤷ Sign Up
Japan	2014198743	ピタバスタチンカルシウムの新規な結晶質形態 (NOVEL CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM)	⤷ Sign Up
Poland	376557	Postacie krystaliczne pitawastatyny wapnia (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM)	⤷ Sign Up
Japan	2020169196	ピタバスタチンカルシウムの新規な結晶質形態 (NOVEL CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM)	⤷ Sign Up
Japan	2015172086	ピタバスタチンカルシウムの新規なアモルファス形態 (NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM)	⤷ Sign Up
Denmark	1715865		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004072040		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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