ROSZET Drug Patent Profile

Which patents cover Roszet, and what generic alternatives are available?

Roszet is a drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in ROSZET is ezetimibe; rosuvastatin calcium. There are twenty-four drug master file entries for this compound. Additional details are available on the ezetimibe; rosuvastatin calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Roszet

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ROSZET

International Patents:	11
US Patents:	2
Applicants:	1
NDAs:	1
What excipients (inactive ingredients) are in ROSZET?	ROSZET excipients list
DailyMed Link:	ROSZET at DailyMed

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

Constraining patent/regulatory exclusivity:

10,376,470

NDA:

213072

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.

US Patents and Regulatory Information for ROSZET

ROSZET is protected by two US patents.

This potential generic entry date is based on patent 10,376,470.

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
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-001	Mar 23, 2021		DISCN	Yes	No	10,376,470		Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No	10,376,470		Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No	10,376,470		Y

International Patents for ROSZET

When does loss-of-exclusivity occur for ROSZET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Hungary

Mexico

Poland

Portugal

Slovenia

Spain

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

See the table below for additional patents covering ROSZET around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013166117
Cyprus	1123091
Hungary	E052300

Supplementary Protection Certificates for ROSZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	03C0028	France		PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017

ROSZET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ROSZET

Introduction to ROSZET

ROSZET, a combination of rosuvastatin and ezetimibe, is a significant player in the coronary artery disease (CAD) therapeutics market. It is used as an adjunct to diet in patients with primary non-familial hyperlipidemia and in patients with homozygous familial hypercholesterolemia (HoFH) to reduce low-density lipoprotein cholesterol (LDL-C)[5].

Market Trends and Growth Drivers

The market for CAD therapeutics, including ROSZET, is poised for substantial growth driven by several key factors:

Rising Approvals and Regulatory Support

Recent approvals by regulatory bodies such as the FDA and Health Canada have significantly boosted the market. For instance, the FDA approved ROSZET in March 2021 for patients with primary non-familial hyperlipidemia, and Health Canada approved MYINFLA 0.5 mg in August 2021 for reducing cardiovascular risk in patients with coronary disease. These approvals are expected to drive segment growth due to the increased adoption of statins[1][4].

Increasing Prevalence of CAD

The surge in the prevalence of coronary artery disease is a major driver of the market. As the global population ages and lifestyle factors contribute to higher cholesterol levels, the demand for effective treatments like ROSZET is on the rise.

High Healthcare Spending and Infrastructure

In regions like North America, high healthcare spending and well-established healthcare infrastructure are fueling the growth of the CAD therapeutics market. This environment supports the adoption and continuous development of new and existing treatments[1][4].

Financial Trajectory

Pricing and Affordability

The cost of ROSZET varies depending on the dosage and pharmacy. For example, a 30-tablet supply of ROSZET (10 mg-5 mg) can cost around $273 for cash-paying customers, although generic versions are available at a lower price point, starting from $86.00 for 30 tablets[2].

Market Size and Forecast

The CAD therapeutics market, which includes ROSZET, is expected to grow at a CAGR of 7.7% by 2028. This growth is driven by the increasing demand for effective cholesterol-lowering therapies and the continuous approval of new products in the segment[4].

Revenue Potential

The revenue potential for ROSZET is significant, given its position as a first-line treatment for managing CAD. With rising approvals and increasing adoption, ROSZET is expected to contribute substantially to the overall market revenue. The global rosuvastatin market, a key component of ROSZET, is also projected to see substantial growth due to increasing healthcare demands and pharmaceutical research[3].

Distribution Channels and Accessibility

ROSZET is available through various distribution channels, including hospital pharmacies, retail pharmacies, and online stores. This wide availability enhances its accessibility to patients, contributing to its market growth.

Competitive Landscape

The CAD therapeutics market is highly competitive, with several key players offering various treatments. ROSZET competes with other statin-based therapies and combination drugs. However, its unique combination of rosuvastatin and ezetimibe and recent regulatory approvals position it favorably in the market[1][4].

Safety and Efficacy Considerations

While ROSZET is effective in reducing LDL-C, it comes with certain safety considerations. It is contraindicated in patients with active liver disease or decompensated cirrhosis and can cause myopathy, rhabdomyolysis, and hepatic dysfunction. These risks necessitate careful patient selection and monitoring[5].

Patient Assistance Programs

To make ROSZET more accessible, patient assistance programs, coupons, and copay cards are available. These programs help reduce the financial burden on patients, making the drug more affordable and increasing its adoption rate[2].

Regional Market Dynamics

The North American region is a significant market for ROSZET, driven by high healthcare spending and a well-established healthcare infrastructure. The market is expected to witness high growth rates in this region due to these factors and the continuous approval of new products[1][4].

Future Market Scope

The future market scope for ROSZET looks promising, driven by emerging industry trends, increasing pharmaceutical research, and the growing demand for healthcare services worldwide. As the global population continues to age and lifestyle factors contribute to higher cholesterol levels, the need for effective treatments like ROSZET will only increase[3].

Key Takeaways

• Regulatory Approvals: Recent approvals by FDA and Health Canada are driving market growth.
• Increasing Prevalence of CAD: The rising prevalence of coronary artery disease is a major market driver.
• High Healthcare Spending: North America's high healthcare spending and infrastructure support market growth.
• Pricing and Affordability: ROSZET's cost varies, but generic versions and patient assistance programs make it more accessible.
• Safety and Efficacy: While effective, ROSZET comes with safety considerations that require careful patient monitoring.
• Future Market Scope: The market is expected to grow significantly due to emerging trends and increasing healthcare demands.

FAQs

What is ROSZET used for?

ROSZET is used as an adjunct to diet in patients with primary non-familial hyperlipidemia and in patients with homozygous familial hypercholesterolemia (HoFH) to reduce low-density lipoprotein cholesterol (LDL-C)[5].

How much does ROSZET cost?

The cost of ROSZET can range from $273 for a 30-tablet supply of the branded version to $86.00 for a generic version of 30 tablets[2].

What are the potential side effects of ROSZET?

ROSZET can cause myopathy, rhabdomyolysis, hepatic dysfunction, and other side effects. It is contraindicated in patients with active liver disease or decompensated cirrhosis[5].

Is ROSZET available through patient assistance programs?

Yes, patient assistance programs, coupons, and copay cards are available to make ROSZET more affordable for patients[2].

What is the forecasted growth rate for the CAD therapeutics market?

The CAD therapeutics market, which includes ROSZET, is expected to grow at a CAGR of 7.7% by 2028[4].

Sources

1. Mordor Intelligence: Coronary Artery Disease Therapeutics Market Trends
2. Drugs.com: Roszet Prices, Coupons, Copay Cards & Patient Assistance
3. Biospace: Rosuvastatin Market Size, Developments Status, Trends and Key Players Analysis, Forecast 2026
4. Mordor Intelligence: Coronary Artery Disease Therapeutics Market - Size, Trends & Growth
5. Roszet.com: Dosing and Administration - Roszet