LIVALO Drug Patent Profile

When do Livalo patents expire, and when can generic versions of Livalo launch?

Livalo is a drug marketed by Kowa Co and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in seventeen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Livalo

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

Summary for LIVALO

International Patents:	53
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	23
Patent Applications:	4,699
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LIVALO
Drug Sales Revenues:	Drug sales revenues for LIVALO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIVALO
What excipients (inactive ingredients) are in LIVALO?	LIVALO excipients list
DailyMed Link:	LIVALO at DailyMed

See drug prices for LIVALO

See drug sales revenues for LIVALO

Recent Clinical Trials for LIVALO

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Amgen	Phase 4
New England Research Institutes	Phase 3

See all LIVALO clinical trials

Pharmacology for LIVALO

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

Anatomical Therapeutic Chemical (ATC) Classes for LIVALO

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

Paragraph IV (Patent) Challenges for LIVALO

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 LIVALO

LIVALO is protected by two US patents.

Patents protecting LIVALO

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					Y
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	No					Y
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No					Y
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	No					Y

Expired US Patents for LIVALO

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

International Patents for LIVALO

See the table below for patents covering LIVALO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2067460
World Intellectual Property Organization (WIPO)	2005079797
European Patent Office	2500339	Formes cristallines de calcium de pitavastatine (Crystalline forms of pitavastatin calcium)
Japan	2011201915	CRYSTALLINE FORM OF PITAVASTATIN CALCIUM