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Last Updated: December 22, 2024

ATORVASTATIN CALCIUM; EZETIMIBE - Generic Drug Details

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

Atorvastatin calcium; ezetimibe is the generic ingredient in two branded drugs marketed by Organon and Althera Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ATORVASTATIN CALCIUM; EZETIMIBE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATORVASTATIN CALCIUM; EZETIMIBE
DailyMed Link:	ATORVASTATIN CALCIUM; EZETIMIBE at DailyMed

Recent Clinical Trials for ATORVASTATIN CALCIUM; EZETIMIBE

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

Sponsor	Phase
Chong Kun Dang Pharmaceutical	Phase 1
Merck Sharp & Dohme Corp.	Phase 3

See all ATORVASTATIN CALCIUM; EZETIMIBE clinical trials

Pharmacology for ATORVASTATIN CALCIUM; EZETIMIBE

Drug Class	Dietary Cholesterol Absorption Inhibitor HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Anatomical Therapeutic Chemical (ATC) Classes for ATORVASTATIN CALCIUM; EZETIMIBE

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 ATORVASTATIN CALCIUM; EZETIMIBE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Althera Pharms	LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-001	Apr 26, 2017		RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Althera Pharms	LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-003	Apr 26, 2017		RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ATORVASTATIN CALCIUM; EZETIMIBE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,846,966*PED	⤷ Subscribe
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013	5,846,966*PED	⤷ Subscribe
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013	5,686,104*PED	⤷ Subscribe
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,686,104*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

ATORVASTATIN CALCIUM; EZETIMIBE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Atorvastatin Calcium and Ezetimibe

Market Overview

Atorvastatin calcium and ezetimibe are crucial medications in the management of high cholesterol and cardiovascular diseases. Here’s a detailed look at their market dynamics and financial trajectory.

Atorvastatin Calcium Market

Market Size and Growth

The global atorvastatin calcium market is projected to experience significant growth. By 2032, the market is expected to reach USD 0.42 billion from USD 0.24 billion in 2024, exhibiting a Compound Annual Growth Rate (CAGR) of 7.5%[1][3].

Driving Factors

The primary drivers of the atorvastatin calcium market include the escalating prevalence of cardiovascular diseases, government support, and unhealthy lifestyles. Increasing health awareness and the importance of cholesterol management also contribute to the growing demand for this medication[1][3].

Market Share and Regional Analysis

North America holds a significant market share of 40.1%, with market revenues reaching USD 92.3 million. The Asia Pacific region is also poised for substantial growth due to increased government initiatives and growing public awareness of healthcare[3].

Generic Dominance

Generic versions of atorvastatin calcium have become prominent, leading to cost-effectiveness and increased accessibility for patients. This shift has significantly impacted the market, with annual spending by Medicare and private health insurance for generic atorvastatin rising substantially[3][4].

Ezetimibe Market Dynamics

Combination Therapies

Ezetimibe is often used in combination with statins like atorvastatin to enhance cholesterol-lowering effects. The fixed-dose combination (FDC) of ezetimibe and atorvastatin has shown efficacy similar to co-administering the two drugs separately, with an additional 15% reduction in LDL-C levels compared to atorvastatin monotherapy[5].

Cost-Effectiveness

Studies have shown that adding ezetimibe to atorvastatin can be a cost-effective strategy compared to switching to other statins like rosuvastatin. In Portugal, for example, this combination was found to be cost-effective based on the national health service's willingness-to-pay threshold[2].

Market Impact

The introduction of generic versions of statins, including those combined with ezetimibe, has led to a significant reduction in brand-name statin purchases. For instance, after the end of market exclusivity, brand-name statin purchases decreased by 90.9% nationally, while generic versions saw a substantial increase in prescriptions[4].

Key Players and Market Strategies

Market Players

Top companies operating in the atorvastatin calcium market include Pfizer, DSM Sinochem Pharmaceuticals, Teva Pharmaceutical Industries, Cadila Pharmaceuticals, and Dr. Reddy’s, among others. These companies are focusing on both organic and inorganic growth strategies such as new product introductions, acquisitions, and partnerships[1][3].

Growth Strategies

Companies are investing in research and development to expand their product portfolios and improve treatment outcomes. The concept of personalized medicine, tailoring dosages and treatment plans based on individual genetic profiles, presents a promising opportunity for market growth[3].

Regional Expansion and Emerging Markets

Emerging Markets

There is a significant opportunity for market expansion in emerging economies where the burden of cardiovascular diseases is growing rapidly. Improving access to healthcare and rising disposable incomes in these regions are expected to drive the demand for atorvastatin calcium and ezetimibe[3].

Asia Pacific Growth

The Asia Pacific region is anticipated to secure a substantial market share due to increased government initiatives, heightened research activity, and growing public awareness of healthcare. This region is pivotal for future developments in the atorvastatin calcium market[3].

Financial Trajectory

Revenue Projections

By 2033, the global atorvastatin calcium market is expected to be worth around USD 571.0 million, growing from USD 230.4 million in 2023 at a CAGR of 9.5%[3].

Expenditure Trends

Annual spending on generic atorvastatin by Medicare and private health insurance has risen significantly, reaching $2.25 billion and $1.88 billion, respectively, in 2018. This trend indicates a shift towards cost-effective generic options[4].

Key Takeaways

The atorvastatin calcium market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and government support.
Combination therapies with ezetimibe are cost-effective and enhance cholesterol-lowering effects.
Generic versions of atorvastatin calcium are dominant, leading to increased accessibility and cost-effectiveness.
Emerging markets, particularly in the Asia Pacific region, offer significant growth opportunities.
Key players are focusing on organic and inorganic growth strategies to expand their market presence.

FAQs

What is the projected market size of atorvastatin calcium by 2032?

The global atorvastatin calcium market is expected to reach USD 0.42 billion by 2032[1].

What is the CAGR of the atorvastatin calcium market from 2024 to 2032?

The atorvastatin calcium market is expected to exhibit a CAGR of 7.5% from 2024 to 2032[1].

Why is the combination of ezetimibe and atorvastatin considered cost-effective?

The combination of ezetimibe and atorvastatin is considered cost-effective because it provides additional cholesterol-lowering benefits at a lower cost compared to switching to other statins like rosuvastatin[2].

Which region holds the largest market share for atorvastatin calcium?

North America holds a significant market share of 40.1% for atorvastatin calcium[3].

What is the impact of generic versions on the atorvastatin calcium market?

Generic versions of atorvastatin calcium have led to increased accessibility and cost-effectiveness, significantly impacting the market by reducing brand-name statin purchases and increasing generic prescriptions[3][4].

Cited Sources:

Business Research Insights: Atorvastatin Calcium Market 2024 To 2032 | Research Report
PubMed: Cost-effectiveness of adding ezetimibe to atorvastatin vs switching to rosuvastatin
Market.us: Atorvastatin Calcium Market Size, Share | CAGR of 9.5%
JAMA Network: Use and Expenditures for Brand-name Statins After Introduction of Generic Statins
FDA: 200153Orig1s000 - accessdata.fda.gov

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