Viewing data from:

ZYPITAMAG

NDA

PITAVASTATIN MAGNESIUM | N208379 | MEDICURE INTERNATIONAL INC

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

Today

8829186

Jan. 19, 2031

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 | 4 NDCs

Highest NADAC/Unit

$7.44

per ea

Lowest NADAC/Unit

$7.41

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
25208020109ZYPITAMAG 2 MG TABLET	$7.44	EA	Brand	—	2026-06-17
25208020115ZYPITAMAG 2 MG TABLET	$7.44	EA	Brand	—	2026-06-17
25208020209ZYPITAMAG 4 MG TABLET	$7.41	EA	Brand	—	2026-06-17
25208020215ZYPITAMAG 4 MG TABLET	$7.41	EA	Brand	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$250.60

Highest Price

$266.35

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
25208-0201-09ZYPITAMAG 2MG TAB	$266.35	FSS	Medicure Pharma Inc.	09/28/2028
25208-0201-09ZYPITAMAG 2MG TAB	$266.35	Big4	Medicure Pharma Inc.	09/28/2028
25208-0202-09ZYPITAMAG 4MG TAB	$250.60	FSS	Medicure Pharma Inc.	09/28/2028
25208-0202-09ZYPITAMAG 4MG TAB	$250.60	Big4	Medicure Pharma Inc.	09/28/2028

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

Medicare Part D Spending

CMS annual spending data for Zypitamag (2024)

Total Spending

$3.9M

Total Claims

8,859

Beneficiaries

2,520

Avg Cost/Unit

$7.43

Spending Trend

$149K(2019)→$241K(2020)→$421K(2021)→$2.6M(2022)→$3.8M(2023)→$3.9M(2024)

YoY Change:-9.7%

5yr CAGR:-1.0%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZYDUS LIFESCIENCES LTDPITAVASTATIN MAGNESIUM

DMF 274632013

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 1, 2024	SUPPL -5	View Letter (PDF)
Sep 28, 2020	SUPPL -4	View Letter (PDF)
Feb 10, 2020	SUPPL -3	View Letter (PDF)
Jul 17, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1MG BASE

RLD

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Jul 14, 2017

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8829186	Jan 19, 2031	—	Yes	Yes	—	—

#002 — EQ 2MG BASE

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 2017

#003 — EQ 4MG BASE

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Jul 14, 2017