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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Zypitamag (2023)

Total Spending

$3.8M

Total Claims

8,034

Beneficiaries

2,268

Avg Cost/Unit

$8.23

Spending Trend

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

YoY Change:+0.4%

5yr CAGR:+1.7%

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