Ezetimibe; rosuvastatin calcium - Generic Drug Details

What are the generic drug sources for ezetimibe; rosuvastatin calcium and what is the scope of freedom to operate?

Ezetimibe; rosuvastatin calcium is the generic ingredient in one branded drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ezetimibe; rosuvastatin calcium has eleven patent family members in ten countries.

Summary for ezetimibe; rosuvastatin calcium

International Patents:	11
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	2
DailyMed Link:	ezetimibe; rosuvastatin calcium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ezetimibe; rosuvastatin calcium

Constraining patent/regulatory exclusivity:

10,376,470

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.

Recent Clinical Trials for ezetimibe; rosuvastatin calcium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Samsung Medical Center	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all ezetimibe; rosuvastatin calcium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ezetimibe; rosuvastatin calcium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

C10AX	Other lipid modifying agents
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for ezetimibe; rosuvastatin calcium

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	213072-002	Mar 23, 2021		DISCN	Yes	No	10,376,470		Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-003	Mar 23, 2021		DISCN	Yes	No	10,376,470		Y
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

International Patents for ezetimibe; rosuvastatin calcium

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

Supplementary Protection Certificates for ezetimibe; rosuvastatin calcium

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

Ezetimibe; rosuvastatin calcium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ezetimibe and Rosuvastatin Calcium

Introduction to Ezetimibe and Rosuvastatin Calcium

Ezetimibe and rosuvastatin calcium are two prominent medications used in the management of hyperlipidemia and the prevention of cardiovascular diseases. Understanding their market dynamics and financial trajectories is crucial for pharmaceutical companies, investors, and healthcare professionals.

Ezetimibe Market Overview

Market Size and Growth

The global ezetimibe market is valued at several billion dollars and is projected to grow at a compound annual growth rate (CAGR) of around 9.3% from 2024 to 2031[1].

Market Segmentation

The market is segmented into branded and generic formulations, with generics gaining significant traction due to their cost-effectiveness. Geographically, North America leads the market, followed by Europe and Asia-Pacific, driven by the rising prevalence of cardiovascular diseases and increasing patient awareness[1].

Key Players and Competitive Landscape

Leading players in the ezetimibe market include Merck, Zydus Cadila, and Amgen. These companies are fostering competition through strategic partnerships and product launches. The market trends indicate an increased focus on combination therapies and patient-centric formulations[1].

Market Drivers and Restraints

Drivers include the rising prevalence of cardiovascular diseases and growing patient awareness. However, restraints such as side effects and pricing pressures from generic entries also impact the market dynamics. Consumer behavior trends focusing on preventive healthcare and cholesterol management are shaping the demand for ezetimibe-based therapies[1].

Rosuvastatin Calcium Market Overview

Market Size and Growth

The global rosuvastatin calcium market was valued at approximately $548.5 million in 2024 and is expected to reach $694.1 million by 2030, growing at a CAGR of 4.0% during the forecast period[2].

Market Segmentation

The market is segmented by type (purity levels of 98.0%, 99.0%, and others) and application (tablets, capsules, and others). Geographically, the EU is the largest consumer, accounting for about 34% of global production, followed by China as the second largest producer[2].

Key Players and Competitive Landscape

Top manufacturers in the rosuvastatin calcium market include AstraZeneca, MSN Laboratories, and Changzhou Pharmaceutical Factory. Other significant players are Cadila Pharmaceuticals, LGM Pharma, and Zhejiang Hisun Pharmaceutical[2].

Market Drivers and Restraints

Drivers include the increasing prevalence of cardiovascular diseases and pharmaceutical research aimed at market expansion. However, healthcare policies can act as a restraining factor, impeding market growth[5].

Combination Therapies: Ezetimibe and Rosuvastatin Calcium

Clinical Significance

Combination therapies involving ezetimibe and rosuvastatin calcium have shown superior clinical performance compared to monotherapy. These combinations help patients achieve target lipid goals and reduce cardiovascular risk more effectively[3].

Market Impact

The development of fixed-dose combinations of ezetimibe and rosuvastatin calcium is a significant trend in the market. This approach enhances patient compliance and offers a more comprehensive lipid-lowering strategy, contributing to the growth of both markets[3].

Financial Trajectory

Ezetimibe Financial Outlook

Given the projected CAGR of 9.3%, the ezetimibe market is expected to see substantial financial growth. The market's value is anticipated to increase significantly over the next seven years, driven by increasing demand and strategic market positioning by key players[1].

Rosuvastatin Calcium Financial Outlook

The rosuvastatin calcium market, with a CAGR of 4.0%, is also poised for steady growth. The market size is expected to increase from $548.5 million in 2024 to $694.1 million by 2030, indicating a stable financial trajectory[2].

Regional Insights

Ezetimibe Regional Market

North America leads the ezetimibe market due to high healthcare expenditure and a high prevalence of hyperlipidemia. Europe and Asia-Pacific follow closely, with emerging markets in Latin America and the Middle East and Africa showing gradual adoption[1].

Rosuvastatin Calcium Regional Market

The EU is the largest consumer of rosuvastatin calcium, followed by China. The regional market dynamics are influenced by local healthcare policies, patient awareness, and the availability of generic formulations[2].

Consumer Behavior and Healthcare Trends

Preventive Healthcare

Consumer behavior trends focusing on preventive healthcare and cholesterol management are driving the demand for both ezetimibe and rosuvastatin calcium. Patients are increasingly seeking effective and affordable treatments to manage lipid profiles and reduce cardiovascular risk[1].

Generic Formulations

The rise of generic formulations is a significant trend in both markets. Generic versions of ezetimibe and rosuvastatin calcium offer cost-effective alternatives, making these medications more accessible to a broader patient population[1][2].

Challenges and Opportunities

Pricing Pressures

Pricing pressures from generic entries are a challenge for both markets. However, this also presents an opportunity for companies to innovate and offer more competitive pricing strategies[1].

Regulatory Environment

Healthcare policies and regulatory environments can impact market growth. Companies must navigate these challenges to ensure continued market expansion[5].

Key Takeaways

• The ezetimibe market is expected to grow at a CAGR of 9.3% from 2024 to 2031, driven by increasing demand and strategic market positioning.
• The rosuvastatin calcium market is projected to grow at a CAGR of 4.0% from 2024 to 2030, driven by the increasing prevalence of cardiovascular diseases.
• Combination therapies involving ezetimibe and rosuvastatin calcium are gaining traction due to their superior clinical performance.
• Regional markets are influenced by local healthcare policies, patient awareness, and the availability of generic formulations.
• Consumer behavior trends focusing on preventive healthcare are driving the demand for both medications.

Frequently Asked Questions

What is the projected CAGR for the ezetimibe market from 2024 to 2031?

The ezetimibe market is expected to grow at a CAGR of 9.3% from 2024 to 2031[1].

What is the expected market size of rosuvastatin calcium by 2030?

The rosuvastatin calcium market is expected to reach $694.1 million by 2030[2].

Which regions lead the market for ezetimibe and rosuvastatin calcium?

North America leads the ezetimibe market, while the EU is the largest consumer of rosuvastatin calcium, followed by China[1][2].

What are the key drivers for the growth of the ezetimibe and rosuvastatin calcium markets?

Key drivers include the rising prevalence of cardiovascular diseases, growing patient awareness, and pharmaceutical research aimed at market expansion[1][5].

How do combination therapies impact the market for ezetimibe and rosuvastatin calcium?

Combination therapies enhance patient compliance and offer a more comprehensive lipid-lowering strategy, contributing to the growth of both markets[3].

Cited Sources

1. Ezetimibe Market Velocity: 9.3% CAGR Trajectory (2024-2031) - Findit.
2. Global Rosuvastatin Calcium Market Insights, Forecast to 2030 - Valuates.
3. Public Assessment Report - Geneesmiddeleninformatiebank - Geneesmiddeleninformatiebank.
4. Ezetimibe and Simvastatin Sales Market Size, Scope And Forecast - Market Research Intellect.
5. Rosuvastatin Calcium Market Size & Forecast To [2032] - Business Research Insights.