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ZYPITAMAG Drug Patent Profile

Which patents cover Zypitamag, and when can generic versions of Zypitamag launch?

Zypitamag is a drug marketed by Medicure and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Zypitamag

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZYPITAMAG

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	10
Drug Prices:	Drug price information for ZYPITAMAG
What excipients (inactive ingredients) are in ZYPITAMAG?	ZYPITAMAG excipients list
DailyMed Link:	ZYPITAMAG at DailyMed

See drug prices for ZYPITAMAG

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZYPITAMAG

Constraining patent/regulatory exclusivity:

8,829,186

NDA:

208379

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ZYPITAMAG

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

US Patents and Regulatory Information for ZYPITAMAG

ZYPITAMAG is protected by one US patents.

This potential generic entry date is based on patent 8,829,186.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379-001	Jul 14, 2017		DISCN	Yes	No	8,829,186		Y	Y
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379-002	Jul 14, 2017		RX	Yes	No	8,829,186		Y	Y
Medicure	ZYPITAMAG	pitavastatin magnesium	TABLET;ORAL	208379-003	Jul 14, 2017		RX	Yes	Yes	8,829,186		Y	Y

International Patents for ZYPITAMAG

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

Country	Patent Number	Title	Estimated Expiration
Japan	2013516459
World Intellectual Property Organization (WIPO)	2011089623

ZYPITAMAG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZYPITAMAG

Introduction

ZYPITAMAG, a statin medication developed by Cadila Healthcare Ltd. (Zydus) and marketed by Medicure Inc., has been a significant player in the cardiovascular pharmaceutical market since its approval by the U.S. Food and Drug Administration (FDA) in 2017. Here, we delve into the market dynamics and financial trajectory of ZYPITAMAG.

Approval and Launch

ZYPITAMAG (pitavastatin magnesium) was approved by the FDA in July 2017 for the treatment of primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet. It was launched in the United States in the second quarter of 2018 through a license agreement between Medicure and Zydus[4].

Indications and Usage

ZYPITAMAG is indicated to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides, and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients. It is available in strengths of 1, 2, and 4 mg and should not exceed 4 mg once daily to avoid the risk of severe myopathy[1][4].

Market Acquisition and Control

In September 2019, Medicure acquired full ownership of ZYPITAMAG for the U.S. and Canadian markets from Zydus. This acquisition included an upfront payment of $5 million, deferred payments of $2 million over four years, and contingent payments based on milestones and royalties. This move gave Medicure full control over marketing and pricing, aligning with their strategy to become a significant cardiovascular company in the U.S. market[1].

Revenue and Sales Performance

Since its launch, ZYPITAMAG has shown a steady growth in sales. For the quarter ended March 31, 2024, ZYPITAMAG generated $777,000 in revenue through insured channels, an increase from $640,000 in the same period in 2023. This growth is attributed to increased sales volume to drug wholesalers in response to stronger demand[2].

In the quarter ended September 30, 2024, ZYPITAMAG contributed $553,000 in revenue through insured channels, up from $398,000 in the same period in 2023. This increase is also due to higher sales volumes to drug wholesalers and enhanced sales through Medicure's pharmacy business, Marley Drug[5].

Financial Impact on Medicure

The financial performance of Medicure has been influenced by the sales of ZYPITAMAG. While the drug has contributed positively to revenue, the overall financial health of Medicure has been affected by various factors. For instance, in the quarter ended March 31, 2024, Medicure reported a net income of $51,000, down from $290,000 in the same period in 2023, due to lower revenue from another product, AGGRASTAT, and higher general and administrative expenses[2].

However, in the quarter ended September 30, 2024, Medicure saw an increase in net income to $680,000, primarily due to higher ZYPITAMAG sales and other income, despite higher costs and lower AGGRASTAT revenue[5].

Market Dynamics: Statin Market Trends

The statin market, in which ZYPITAMAG operates, has undergone significant changes over the years. From 1991 to 2005, statin prescriptions and expenditures skyrocketed, with brand-name statins dominating the market. However, after 2006, the introduction of generic statins led to a sharp decline in brand-name statin use and expenditures. By 2022, generic statins had captured nearly 100% of the market share by prescriptions and over 95% by expenditure[3].

ZYPITAMAG, as a relatively newer entrant, benefits from being a cost-effective alternative in a market where generic statins are prevalent. Its positioning as a pitavastatin product, developed via a 505(b)(2) New Drug Application (NDA) procedure, allows it to compete effectively in the generic-dominated market[4].

Competitive Landscape

The statin market is highly competitive, with several established brands and generics. ZYPITAMAG competes with other statins like atorvastatin, simvastatin, and rosuvastatin. However, its unique profile and cost-effectiveness make it an attractive option for patients and healthcare providers. The partnership with Zydus and the acquisition of full ownership by Medicure have strengthened its market presence[1][3][4].

Future Outlook

Given the increasing demand for statins and the growing preference for generic and cost-effective options, ZYPITAMAG is well-positioned for continued growth. Medicure's strategic focus on the U.S. market and the expansion of its pharmacy business through Marley Drug are expected to further boost ZYPITAMAG sales.

Key Takeaways

• Approval and Launch: ZYPITAMAG was approved by the FDA in 2017 and launched in the U.S. in 2018.
• Market Acquisition: Medicure acquired full ownership of ZYPITAMAG in 2019.
• Revenue Growth: ZYPITAMAG has shown steady revenue growth through insured channels.
• Financial Impact: The drug has positively contributed to Medicure's revenue but faces challenges from other product lines and operational costs.
• Market Trends: The statin market is dominated by generics, with ZYPITAMAG positioned as a cost-effective alternative.
• Competitive Landscape: ZYPITAMAG competes with established statin brands and generics.

FAQs

What is ZYPITAMAG used for?

ZYPITAMAG is used as an adjunctive therapy to diet to reduce elevated total cholesterol, LDL-C, apolipoprotein B, triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia[1][4].

Who developed and markets ZYPITAMAG?

ZYPITAMAG was developed by Cadila Healthcare Ltd. (Zydus) and is marketed by Medicure Inc. in the U.S. and Canadian markets[1][4].

How has the revenue of ZYPITAMAG performed?

ZYPITAMAG has shown an increase in revenue through insured channels, with $777,000 in the quarter ended March 31, 2024, and $553,000 in the quarter ended September 30, 2024[2][5].

What are the key factors affecting Medicure's financial performance related to ZYPITAMAG?

The financial performance is influenced by higher sales of ZYPITAMAG, but also impacted by lower revenue from other products, higher general and administrative expenses, and research and development costs[2][5].

How does ZYPITAMAG fit into the broader statin market?

ZYPITAMAG operates in a market dominated by generic statins, offering a cost-effective alternative to brand-name statins, which have seen a decline in use and expenditures since 2006[3].

What is the future outlook for ZYPITAMAG?

Given the increasing demand for statins and the preference for generic options, ZYPITAMAG is expected to continue growing, especially with Medicure's strategic focus on the U.S. market and expansion of its pharmacy business[1][3][5].

Sources

1. Medicure Announces Acquisition Of Full United States Ownership Of ZYPITAMAG™ - Medicure Inc.
2. Medicure Reports Financial Results For Quarter Ended March 31, 2024 And Annual General Meeting Director Election Results - Medicure Inc.
3. A Retrospective Trend Analysis of Utilization, Spending, and Prices for Generic Statins in the US Medicaid Population, 1991-2022 - AHDB Online
4. Medicure Launches Zypitamag Statin in the United States - CIToday
5. Medicure Reports Financial Results For Quarter Ended September 30, 2024 - Medicure Inc.