Ezetimibe - Generic Drug Details

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

Ezetimibe is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Organon, Althera Pharms, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, and Torrent, and is included in twenty-eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ezetimibe has two hundred and thirty-five patent family members in thirty-eight countries.

There are twenty-four drug master file entries for ezetimibe. Twenty-seven suppliers are listed for this compound.

Summary for ezetimibe

International Patents:	235
US Patents:	3
Tradenames:	5
Applicants:	22
NDAs:	28
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	381
Drug Prices:	Drug price trends for ezetimibe
Drug Sales Revenues:	Drug sales revenues for ezetimibe
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ezetimibe
What excipients (inactive ingredients) are in ezetimibe?	ezetimibe excipients list
DailyMed Link:	ezetimibe at DailyMed

See drug prices for ezetimibe

See drug sales revenues for ezetimibe

Recent Clinical Trials for ezetimibe

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

Sponsor	Phase
Bahria University	PHASE4
Sohaib Ashraf	PHASE3
Daiichi Sankyo	PHASE1

See all ezetimibe clinical trials

Pharmacology for ezetimibe

Drug Class	Dietary Cholesterol Absorption Inhibitor
Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for ezetimibe

Anticholesteremic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ezetimibe

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

Paragraph IV (Patent) Challenges for EZETIMIBE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZETIA	Tablets	ezetimibe	10 mg	021445	1	2006-10-25

US Patents and Regulatory Information for ezetimibe

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	213072-003	Mar 23, 2021		DISCN	Yes	No	9,763,885		Y
Watson Labs Inc	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	202968-004	Apr 26, 2017	AB	RX	No	No
Aurobindo Pharma	EZETIMIBE	ezetimibe	TABLET;ORAL	209838-001	Aug 25, 2017	AB	RX	No	No
Watson Labs Inc	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	202968-003	Apr 26, 2017	AB	RX	No	No
Aurobindo Pharma Usa	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	200082-001	Dec 17, 2020	AB	RX	No	No

Expired US Patents for ezetimibe

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	5,767,115
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	RE42461*PED
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	RE37721*PED
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	5,846,966*PED
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	7,030,106*PED

International Patents for ezetimibe

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1363668	COMBINAISONS DE CHELATEUR(S) DES ACIDES BILIAIRES ET D'INHIBITEUR(S) D'ABSORPTION DES STEROLS, ET TRAITEMENTS POUR TROUBLES VASCULAIRES (COMBINATIONS OF BILE ACID SEQUESTRANT(S) AND STEROL ABSORPTION INHIBITOR(S) AND TREATMENTS FOR VASCULAR INDICATIONS)
Cyprus	1107174
Russian Federation	2003126186
Norway	331512
Slovakia	9492003	Combinations of sterol absorption inhibitor(s) with cardiovascular agent(s) for the treatment of vascular conditions

Supplementary Protection Certificates for ezetimibe

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	C300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0720599	92544	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0720599	C300132	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION: RVG 28626 20030418; FIRST REGISTRATION: DE 54486.00.00, 54487.00.00, 54488.00.00, 54489.00.00 20021017
0720599	2003/014	Ireland		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: 1091/1/1 00040127; FIRST REGISTRATION NO/DATE: EU: DE 54489.00.00 54486.00.00 54488.00.00 54487.00.00 20021017; PAEDIATRIC INVESTIGATION PLAN: P/0061/2012
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402

Market Dynamics and Financial Trajectory for Ezetimibe: An In-Depth Analysis

Last updated: December 27, 2025

Summary

Ezetimibe, marketed under the brand Zetia (Schering-Plough, now part of Merck & Co.), is a lipid-lowering agent primarily used to reduce low-density lipoprotein cholesterol (LDL-C). Since its approval in 2002, ezetimibe has established itself within the cardiovascular therapeutics landscape, often employed alone or in combination with statins. This report examines the evolving market dynamics shaping ezetimibe’s commercial outlook, explores its financial trajectory, analyzes competitive and regulatory influences, and provides strategic insights for industry stakeholders.

---

What Are the Current Market Dynamics for Ezetimibe?

Overview of the Ezetimibe Market

Ezetimibe’s market position is influenced by advances in lipid-lowering therapies, cardiovascular risk management, and evolving clinical guidelines. These dynamics are detailed below.

Aspect	Details
Market Size (2022)	Approximately $2.4 billion globally (estimated), with a compound annual growth rate (CAGR) of 4-6% over the past five years.
Key Markets	United States, Europe, Japan, emerging markets (e.g., China, India).
Growth Drivers	Rising prevalence of hypercholesterolemia, cardiovascular diseases (CVD), and increased awareness of familial and primary prevention.
Challenges	Competition from PCSK9 inhibitors, patient adherence issues, generic erosion, and shifting guidelines.

Clinical and Regulatory Influences

• Guidelines Influence: The American College of Cardiology/American Heart Association (ACC/AHA) guidelines (2018) emphasize high-intensity statin therapy, often relegating ezetimibe to second-line or add-on use despite evidence supporting combination therapy (such as IMPROVE-IT trial results).
• Health Policies: Payer dynamics influence formulary inclusion; in some regions, ezetimibe is preferred as a cost-effective alternative to more expensive biologics.
• Patent Life and Generics: Ezetimibe’s original patent expired in 2014, leading to multiple generic competitors reducing price points and affecting revenue streams.

Competitive Landscape

Competitors	Type	Key Features	Market Share (2022)
Generic Ezemtibie	Brand-agnostic	Price competition, mass availability	>70% (by volume)
Cholestyramine & Bile Acid Sequestrants	Oral therapies	Cost-effective but less tolerated	declining as ezetimibe gains favor
PCSK9 Inhibitors (evolocumab, alirocumab)	Biologics	Higher efficacy but costly	Growing segment (~2-3%) but impacting ezetimibe’s market share
Inclisiran	siRNA therapy	Emerging, similar indication	Limited but rising

---

What Is the Financial Trajectory for Ezetimibe?

Revenue Trends and Projections

Parameter	2022	2023 (Estimate)	2025 Projection	Description
Global Revenue	~$2.4B	~$2.5B	~$2.6B	Slight growth driven by price recovery in emerging markets; offset by patent expiry impacts
Unit Sales	150 million prescriptions	155 million	165 million	Slight increasing trend aligned with rising cardiovascular disease burden
Average Price per Unit	~$16	~$15.50 (post-generic discounting)	~$14	Price erosion due to generics; stabilization in certain markets

Revenue Drivers

• Market Penetration in Developing Economies: Rapid growth anticipated due to increasing cardiovascular risk awareness.
• Combination Therapy Trends: Growing adoption of ezetimibe with statins (e.g., Vytorin), which sustains revenue streams.
• Clinical Evidence Influence: The IMPROVE-IT trial demonstrated the added benefit of ezetimibe plus simvastatin, bolstering its clinical credibility and prescribing rates.

Key Revenue Challenges

Factor	Impact	Mitigation Strategies
Generic Competition	Price pressure, revenue erosion	Diversification, premium formulations, value-added indications
Emerging Alternative Therapies	Market share shifts	Differentiation via enhanced formulations or combination regimens
Regulatory Changes	Reimbursement policy shifts	Strategic engagement with payers, cost-benefit positioning

---

How Do Competitive and Regulatory Forces Shape the Financial Outlook?

Impact of Patent Expiry and Generics

Timeline	Impact	Market Response
Pre-2014	Monopoly pricing, high margins	Revenue peaked (~$2.7 billion in 2012)
2014-2015	Entry of generics, price decline	Revenue declines (~$1.6 billion by 2015)
Post-2015	Market consolidation, volume-driven growth	Stabilization at ~$2 billion

Emerging Therapies and Market Share Redistribution

Therapies	Efficacy	Cost	Role in Market
PCSK9 Inhibitors	Up to 60% LDL-C reduction	~$14,000/year	Adjuncts for high-risk patients, reducing ezetimibe’s share in high-income segments
Inclisiran	~50-55% LDL-C reduction	~$6,000/year	Potential substitute for ezetimibe in some indications

Regulatory Policies Impacting Revenue

• Formulary Inclusion: Payers favor cost-effective generic options; poor coverage can limit ezetimibe use.
• Price Capping & Reimbursement Cuts: Implemented in certain regions (e.g., EU, Japan), pressuring margins.
• Manufactora Strategies: Merck’s launch of combination products (e.g., Vytorin) with ezetimibe sustains market presence.

---

Projections and Strategic Outlook

Scenario	Key Assumptions	Projected Revenue (2025)	Implications
Optimistic	Increased adoption due to guideline updates; improved patient adherence	~$2.8B	Stronger market share, possibly via new formulations or indications
Baseline	Continued generic competition; stable prescribing patterns	~$2.6B	Marginal growth, competitive pressures persist
Pessimistic	Emergence of superior therapies; regulatory restrictions	~$2.2B	Revenue decline; need for pipeline innovation

Table 1: Ezetimibe Market Summary (Key Metrics)

Parameter	Value	Notes
Global Market Size (2022)	~$2.4 billion	Estimated
Compound Annual Growth Rate (2017–2022)	4-6%	Driven by emerging markets
Patent Expiry Date	2014	Multiple generics launched post-2014
Main Competitors	Generic formulations, PCSK9 inhibitors, inclisiran	Market share decreasing for original brands

---

What Are the Major Differences Between Ezetimibe and Alternative Lipid-Lowering Agents?

Attribute	Ezetimibe	Statins	PCSK9 Inhibitors	Inclisiran
Mechanism	Inhibits intestinal cholesterol absorption	Inhibits HMG-CoA reductase	Monoclonal antibodies inhibit PCSK9	RNA interference targeting PCSK9 mRNA
Efficacy	~20% LDL-C reduction	30–50% LDL-C reduction	~60% LDL-C reduction	~50–55% LDL-C reduction
Cost	~$15–20 per month	~$10–20 per month	~$14,000/year	~$6,000/year
Administration	Oral	Oral	Subcutaneous injection	Subcutaneous injection
Guideline Position	Add-on therapy	First-line	For high-risk/high-intensity cases	Emerging alternative

---

Key Takeaways

• Ezetimibe remains a cornerstone adjunct in lipid management, especially post-IMPORVE-IT, which bolstered its clinical value.
• Patent expiration led to increased generic competition, causing revenue decline but stabilizing sales through volume.
• The market outlook is favorable in emerging economies, where rising cardiovascular risks and health policies favor cost-effective drugs.
• Competition from powerful biologics (PCSK9 inhibitors) and gene therapies (inclisiran) restrict ezetimibe’s growth in high-income segments.
• Strategic positioning may entail innovation in formulations, expansion into new indications, or combination therapies.

---

FAQs

1. How has the patent expiry affected ezetimibe’s market share and revenue?
Patent expiry in 2014 introduced multiple generics, dramatically reducing prices by up to 80%. While revenue declined sharply initially, volume increases and market stabilization have sustained roughly $2 billion annual sales.

2. What clinical evidence supports ezetimibe’s continued relevance?
The IMPROVE-IT trial (2015) demonstrated that adding ezetimibe to statin therapy provided a significant reduction in cardiovascular events beyond statins alone, reinforcing its role in secondary prevention.

3. How do political and regulatory policies influence ezetimibe’s market?
Health authorities emphasizing cost-effectiveness and payers’ formulary decisions significantly influence ezetimibe’s access. In some regions, strict reimbursement policies favor generics, further pressuring margins.

4. What are the prospects of ezetimibe’s market in emerging economies?
Rapid urbanization, increasing awareness, and government initiatives make emerging markets highly promising. Market expansion hinges on affordability and integration into broader treatment guidelines.

5. How does ezetimibe compare with newer therapies like inclisiran?
Inclisiran offers comparable LDL-C reduction via subcutaneous injection administered twice a year, potentially replacing ezetimibe in certain high-risk patients, but at a substantially higher cost.

---

References

[1] Sansonno D, et al. “Ezetimibe: A Review of Its Use in Lipid Management.” Drugs, 2012;72(9):1191–1204.
[2] Cannon CP, et al. “Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.” N Engl J Med, 2015;372(25):2387–2397.
[3] MarketsandMarkets. “Lipid-Lowering Drugs Market by Type, Distribution Channel, and Region.” 2022.
[4] FDA. “Ezetimibe (Zetia) Drug Label,” 2002.
[5] European Society of Cardiology. “2019 ESC/EAS Guidelines for Management of Dyslipidemias.”*
[6] IQVIA. “Global Pharmaceutical Market Trends,” 2022.