Viewing data from:

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Livalo (2023)

Total Spending

$189.9M

Total Claims

283,494

Beneficiaries

70,926

Avg Cost/Unit

$10.92

Spending Trend

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

YoY Change:+0.6%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2023). 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