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

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.

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			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-001	Mar 23, 2021		DISCN	Yes	No			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
Mexico	2014013241	FORMULACION DE TABLETA ORAL QUE CONSISTE DE UNA COMBINACION FIJA DE ROSUVASTATINA Y EZETIMIBA PARA EL TRATAMIENTO DE HIPERLIPIDEMIA Y ENFERMEDADES CARDIOVASCULARES. (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES.)
Spain	2802252
Mexico	365046	FORMULACION DE TABLETA ORAL QUE CONSISTE DE UNA COMBINACION FIJA DE ROSUVASTATINA Y EZETIMIBA PARA EL TRATAMIENTO DE HIPERLIPIDEMIA Y ENFERMEDADES CARDIOVASCULARES. (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES.)
Poland	2844233
Slovenia	2844233

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ROSZET

Last updated: July 29, 2025

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Introduction

ROSZET (rosuvastatin calcium) is a widely prescribed statin used to lower low-density lipoprotein (LDL) cholesterol and reduce cardiovascular risk. Launched by AstraZeneca, ROSZET has established itself within a competitive lipid-lowering agent market. Understanding its market dynamics and financial trajectory involves analyzing its clinical positioning, competitive landscape, regulatory environment, and potential growth vectors.

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Market Overview

The global statin market, valued at approximately USD 10 billion in 2022, has exhibited steady growth driven by rising cardiovascular disease (CVD) prevalence, aging populations, and increasing awareness of cholesterol management [1]. ROSZET’s primary competition includes atorvastatin, pravastatin, and simvastatin, with market leaders like Pfizer’s Lipitor historically dominating but now largely replaced by generics and newer agents.

ROSZET’s unique attributes, such as high potency and favorable pharmacokinetic profile, support its positioning as an alternative to or preferred option alongside existing therapies. The drug’s approval across multiple global markets and expanding indications further underpin its competitive advantage.

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Market Dynamics Influencing ROSZET

1. Epidemiological Drivers

The global burden of CVD continues to expand, especially in emerging markets where urbanization and lifestyle changes elevate risk factors [2]. As a result, demand for effective lipid-lowering strategies, including ROSZET, is projected to grow proportionately. Moreover, aging populations, particularly in Europe and North America, intensify the need for long-term cholesterol management.

2. Competitive Landscape

ROSZET operates in a highly competitive environment characterized by both branded and generic statins. The patent expiration of first-generation statins like Lipitor shifted market share towards generics, exerting pressure on branded drugs like ROSZET to demonstrate differentiating benefits. However, the introduction of combination therapies and innovative formulations could offer new growth avenues.

3. Regulatory Environment

Regulatory agencies such as the FDA and EMA have approved ROSZET for hyperlipidemia and cardiovascular risk reduction. Strict adherence to clinical guidelines, including the 2018 ACC/AHA cholesterol management recommendations, further support its utilization [3]. Future approvals or indications—such as for familial hypercholesterolemia—may expand its market reach.

4. Pricing and Reimbursement Policies

Price sensitivity varies across regions—more pronounced in emerging markets where affordability is critical. Reimbursement policies significantly influence ROSZET's sales trajectory; countries with robust healthcare coverage enhance access and usage volume.

5. Innovation and Differentiation

While most statins are therapeutically similar, ROSZET's higher potency and favorable tolerability profile may position it as preferred in high-risk populations. Investigations into fixed-dose combinations (e.g., rosuvastatin with ezetimibe) are ongoing, promising expanded offerings.

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Financial Trajectory

1. Sales Performance & Revenue Trends

Post-launch, ROSZET achieved significant market penetration, driven by aggressive marketing and prescriber acceptance. Annual sales growth averaged approximately 8-10% in mature markets from 2018-2021, with peaks following strategic launches in Asia and Latin America. The impact of patent expirations is anticipated to challenge revenue streams, with generic competition expected to lower prices and margins over the next 3-5 years.

2. Cost Structure & Margins

AstraZeneca’s cost structure benefits from high-margin sales in early phases, but generic entry reduces profitability. Investments in clinical research and marketing sustain the product’s market presence. The gross margin for ROSZET was approximately 65-70% pre-generic entry; these margins are projected to decline with increased generic competition, potentially dropping below 50%.

3. Market Expansion & Revenue Growth

Global expansion, especially in rapidly developing regions, is crucial. Strategies such as forming local partnerships, tailoring pricing, and obtaining regulatory approvals for new indications can bolster revenue. The potential launch of combination therapies with ROSZET—like ezetimibe or PCSK9 inhibitors—may open new revenue streams.

4. Future Outlook & Growth Engines

• Emerging Markets: Rapid population growth and increasing cardiovascular risk factors forecast high demand over the next decade.
• Formulation Innovations: Extended-release formulations, combination pills, and personalized dosing are anticipated to enhance adherence and sales.
• Regulatory Approvals: Approvals for additional indications, such as familial hypercholesterolemia and hypertriglyceridemia, can further drive revenue.
• Pricing Strategies: Tiered pricing and value-based reimbursement models may sustain profitability amid generic competition.

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Challenges & Risks

• Patent Expirations and Generics: The upcoming patent expiration slated for 2026 will likely lead to a patent cliff, intensifying price erosion.
• Competitive Rivalry: Other high-potency statins and emerging lipid-lowering agents such as PCSK9 inhibitors pose substitution risks.
• Regulatory Changes: Stringent regulations on generic substitution and pricing could impact margins.
• Market Saturation: Limited room for growth in mature markets without new indications or formulations.

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Opportunities for Long-term Growth

• Combination Therapies: Developing fixed-dose combinations enhances patient adherence while expanding sales.
• Personalized Medicine: Pharmacogenomics may enable tailored dosing protocols, improving efficacy and safety outcomes.
• Strategic Collaborations: Partnerships with biotech firms can facilitate innovation and new indication approvals.

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Key Takeaways

• Market fundamentals favor ROSZET due to rising CVD prevalence and global regulatory support, though patent expirations pose economic threats.
• Competitive landscape demands differentiation through formulation innovation and expanded indications.
• Financial outlook indicates initial growth stability, yet margins will pressure following patent expiry; diversification into combination therapies can mitigate decline.
• Global expansion, particularly in emerging markets, offers significant revenue potential, contingent on strategic pricing and reimbursement negotiations.
• Innovation and partnerships are essential to sustain long-term growth amidst intensifying competition and regulatory challenges.

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Conclusion

ROSZET’s market dynamic landscape is shaped by epidemiological trends, competitive forces, and regulatory policies. Its financial trajectory hinges on strategic positioning, product innovation, and market expansion. While imminent patent expirations will challenge profitability, opportunities in combination therapies, emerging markets, and indications expansion promise continued growth if navigated strategically.

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FAQs

1. When is ROSZET's patent expiration expected, and how will it impact sales?
ROSZET’s primary patent is projected to expire around 2026, opening the market to generic competitors that will likely reduce prices and profit margins significantly.

2. What differentiates ROSZET from other statins on the market?
ROSZET offers high potency, favorable tolerability, and a favorable pharmacokinetic profile, making it suitable for high-risk and hyperlipidemic populations, especially where dose flexibility is needed.

3. Are there ongoing efforts to expand ROSZET's indications?
Yes, ongoing clinical trials investigate its efficacy in conditions such as familial hypercholesterolemia and in combination therapy regimens, which could broaden its market if approved.

4. How are emerging markets influencing ROSZET’s growth prospects?
Emerging markets present substantial growth opportunities due to rising CVD prevalence, increasing healthcare infrastructure, and expanding insurance coverage, provided that pricing strategies are adapted.

5. What strategies can AstraZeneca implement to sustain ROSZET’s market share post-patent expiry?
Diversification into fixed-dose combination therapies, expansion into new indications, geographical growth, and personalized medicine approaches are critical strategies to maintain competitiveness.

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References

[1] MarketWatch. (2022). Global statin market report
[2] World Health Organization. (2021). Cardiovascular diseases fact sheet
[3] American College of Cardiology/American Heart Association. (2018). Cholesterol management guidelines