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LIVALO

NDA

PITAVASTATIN CALCIUM | N022363 | KOWA CO LTD

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Kowa Company, Ltd. et al v. Hetero Drugs Limited et al 1:2017cv00762	D. Del.	2017-06-14	Terminated 2018-10-02	—
Kowa Company Ltd. et al v. Apotex Inc. et al 1:2014cv01264 1 patentANDA 206068pitavastatin calcium	D. Del.	2014-10-02	Terminated 2015-02-20	—
Kowa Company, Ltd. et al v. Sawai USA, Inc. et al 1:2014cv05575 3 patentsANDA 205955pitavastatin calcium	S.D.N.Y.	2014-07-23	Terminated 2017-01-26	—
Kowa Company, Ltd. et al v. Aurobindo Pharma Limited et al 1:2014cv02497 2 patentsANDA 20-6015pitavastatin calcium	S.D.N.Y.	2014-04-09	Terminated 2015-12-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

40 trials from ClinicalTrials.gov, 33 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin NCT00309738	Phase 3	Completed	Kowa Research Europe	355	2005-09 → 2006-10
South Korean Pitavastatin Heart Failure Study NCT00701285	Phase 4	Completed	JW Pharmaceutical	70	2008-07 → 2014-05
Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin NCT01057433	Phase 4	Completed	Kowa Research Institute, Inc.	24	2010-01 → 2010-12
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects NCT01301066	Phase 4	Completed	Kowa Research Institute, Inc.	252	2010-12 → 2013-03
Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz NCT01695954	Phase 1	Completed	NYU Langone Health	34	2012-05 → 2013-01
To Evaluate the Safety and PK Characteristics in Healthy Volunteers-Livalozet NCT01764178	Phase 1	Completed	JW Pharmaceutical	52	2013-01-22 → 2013-12-27
A Study of LY3015014 in Participants With High Cholesterol NCT01890967	Phase 2	Completed	Eli Lilly and Company	527	2013-06 → 2014-06
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia NCT00309751	Phase 3	Completed	Kowa Research Europe	418	2005-12 → 2007-06
Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)NCT00861861	Phase 4	Completed	Kumamoto University	129	2008-09 → 2013-10
Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)NCT00242944	Phase 4	Completed	Kyoto University	307	2005-11 → 2008-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$10.22

per ea

Lowest NADAC/Unit

$10.19

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66869040490LIVALO 4 MG TABLET	$10.22	EA	Brand	$1.27	2026-06-17
66869010490LIVALO 1 MG TABLET	$10.20	EA	Brand	$1.20	2026-06-17
66869020490LIVALO 2 MG TABLET	$10.19	EA	Brand	$1.15	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$717.94

Highest Price

$717.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66869-0104-90LIVALO 1MG TAB	$717.94	FSS	Kowa Pharmaceuticals America, Inc.	03/31/2028
66869-0204-90LIVALO 2MG TAB	$717.94	FSS	Kowa Pharmaceuticals America, Inc.	03/31/2028
66869-0404-90LIVALO 4MG TAB	$717.96	FSS	Kowa Pharmaceuticals America, Inc.	03/31/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Livalo (2024)

Total Spending

$90.6M

Total Claims

143,372

Beneficiaries

37,775

Avg Cost/Unit

$10.41

Spending Trend

$163.9M(2019)→$189.6M(2020)→$206.2M(2021)→$206.9M(2022)→$189.9M(2023)→$90.6M(2024)

YoY Change:-4.7%

5yr CAGR:+0.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs2 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

NISSAN CHEMICAL CORPPITAVASTATIN CALCIUM

DMF 146602000

MSN LABORATORIES PRIVATE LTDPITAVASTATIN CALCIUM (PENTAHYDRATE)

DMF 234882010

SOLARA ACTIVE PHARMA SCIENCES LTDPITAVASTATIN CALCIUM

DMF 259562012

APITORIA PHARMA PRIVATE LTDPITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE)

DMF 271062013

MATRIX PHARMACORP PRIVATE LTDPITAVASTATIN CALCIUM

DMF 271442013

LUPIN LTDPITAVASTATIN CALCIUM

DMF 272422013

HETERO DRUGS LTDPITAVASTATIN CALCIUM

DMF 272552013

ZYDUS LIFESCIENCES LTDPITAVASTATIN CALCIUM

DMF 273332013

NISSAN CHEMICAL CORPPITAVASTATIN CALCIUM (ASYMMETRIC SYNTHESIS METHOD)

DMF 277612013

KOLON LIFE SCIENCE INCPITAVASTATIN CALCIUM

DMF 321692018

WANBANG BIOPHARMACEUTICALSPITAVASTATIN CALCIUM

DMF 323452017

FUXIN LONG RUI PHARMACEUTICAL CO LTDPITAVASTATIN CALCIUM

DMF 334892019

APITORIA PHARMA PRIVATE LTDPITAVASTATIN CALCIUM (PROCESS-II)

DMF 413302025

FORMOSA LABORATORIES INCPITAVASTATIN CALCIUM HYDRATE

DMF 425302025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactivePITAVASTATIN CALCIUM

DMF 264062012

JILIN ASYMCHEM LABORATORIES CO LTDInactivePITAVASTATIN CALCIUM

DMF 283842014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Mar 15, 2024	SUPPL -22	View Letter (PDF)
Nov 10, 2022	SUPPL -20	View Letter (PDF)
Sep 28, 2020	SUPPL -18	View Letter (PDF)
Oct 22, 2019	SUPPL -17	View Letter (PDF)
May 17, 2019	SUPPL -15	View Letter (PDF)
Nov 22, 2016	SUPPL -11	View Letter (PDF)
Oct 18, 2013	SUPPL -12	View Letter (PDF)
Nov 6, 2012	SUPPL -10	View Letter (PDF)
Feb 28, 2012	SUPPL -9	View Letter (PDF)
Feb 28, 2012	SUPPL -8	View Letter (PDF)
Aug 5, 2011	SUPPL -6	View Letter (PDF)
Jun 27, 2011	SUPPL -5	View Letter (PDF)
Jun 8, 2010	SUPPL -2	View Letter (PDF)
Aug 26, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 3, 2009

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 3, 2009

#003 — EQ 4MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 3, 2009