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
Sciegen Pharms Inc	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	211663-002	Dec 10, 2024		DISCN	No	No
Torrent	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	209461-002	Jan 27, 2025		DISCN	No	No
Glenmark Pharms Ltd	EZETIMIBE AND SIMVASTATIN	ezetimibe; simvastatin	TABLET;ORAL	208699-003	Jun 27, 2019	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	RE42461*PED
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	5,767,115
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	RE37721*PED

International Patents for EZETIMIBE

Country	Patent Number	Title	Estimated Expiration
Japan	2004517919
Slovakia	9502003	Combinations of sterol absorption inhibitor(s) with blood modifier(s) for treating vascular conditions
Japan	4937836

Supplementary Protection Certificates for EZETIMIBE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	CR 2014 00048	Denmark		PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0720599	03C0028	France		PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
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

Last updated: September 17, 2025

Introduction

Ezetimibe, a lipid-lowering agent primarily prescribed for hyperlipidemia management, has carved out a significant niche within cardiovascular therapeutics. Since its approval by the U.S. Food and Drug Administration (FDA) in 2002, ezetimibe has transitioned from a niche cholesterol absorption inhibitor to a cornerstone within combination therapies aimed at reducing cardiovascular risk. This analysis explores the evolving market dynamics, regulatory landscape, competitive positioning, and financial outlook for ezetimibe, offering valuable insights for stakeholders in the pharmaceutical sector.

Pharmacological Profile and Clinical Significance

Ezetimibe selectively inhibits the Niemann-Pick C1-Like 1 (NPC1L1) transporter in the small intestine, effectively reducing intestinal absorption of dietary and biliary cholesterol. Its mechanism complements statins, which primarily inhibit hepatic cholesterol synthesis, fostering combined lipid-lowering effects. Clinical trials, such as the IMPROVE-IT study, demonstrated that adding ezetimibe to statin therapy significantly reduces cardiovascular events, affirming its clinical value [1].

The drug's safety profile is favorable, with minimal adverse effects, thus supporting widespread use, particularly among patients intolerant to high-dose statins or requiring additional lipid lowering.

Market Dynamics

Current Market Landscape

Ezetimibe's global market is active, with Ezetimibe (marketed as Zetia and others) maintaining robust sales. According to IQVIA, the global sales of ezetimibe formulations peaked around $2.3 billion in 2022, reflecting its entrenched position in hyperlipidemia management [2]. North America remains the leading revenue generator, driven by high cardiovascular disease prevalence and aggressive treatment protocols.

Competitive Environment

While ezetimibe faces competition from newer agents, notably PCSK9 inhibitors (e.g., alirocumab, evolocumab), these biologics target a different segment—patients with refractory hyperlipidemia or familial hypercholesterolemia—usually at a higher cost point. Genetically, ezetimibe's patent expiration has catalyzed a wave of generic manufacturing, intensifying price competition, reducing overall sales prices, and expanding access.

Regulatory & Patent Landscape

Original patents for ezetimibe expired in key markets by 2016, prompting generics to flood the market [3]. This patent expiry has led to significant price erosion—marketed generic ezetimibe drugs are approximately 40% cheaper than protected formulations—affecting branded sales revenue. Nonetheless, branded formulations retain some market appeal owing to physician preference and established prescribing habits.

Emerging Therapeutic Indications

Recent research explores ezetimibe's role beyond hyperlipidemia. Investigations into its anti-inflammatory effects and potential benefits in non-alcoholic steatohepatitis (NASH) suggest avenues for expanded indications. However, regulatory approval for such uses remains pending, limiting immediate financial impact.

Financial Trajectory Analysis

Revenue Trends

The ezetimibe market experienced maturity around 2015-2017, with revenues plateauing due to increased generic penetration and market saturation. However, incremental growth persists driven by emerging markets, better diagnostic rates, and wider routine screening for lipid disorders.

Growth Drivers

• Expanding Global Cardiovascular Disease (CVD) Burden: The 17.9 million annual deaths attributable to CVD worldwide [4] intensify demand for effective lipid-lowering therapies.
• Policy and Guideline Changes: Increased adoption of guidelines recommending lower LDL-C targets bolster prescriptions.
• Generic Market Penetration: Affordable generics have increased accessibility in low- and middle-income countries, expanding volume sales.

Market Challenges

• Price Competition: The widespread availability of generics compresses profit margins.
• Market Saturation: In developed countries, most eligible patients are on combination therapy, limiting further penetration.
• Emerging Market Risks: Variability in healthcare infrastructure and regulatory environments pose challenges to uniform market expansion.

Future Outlook

The future financial trajectory hinges on several factors:

• Market Penetration in Developing Countries: Increased awareness and infrastructure can unlock substantial volume growth.
• Combination Therapies and Fixed-Dose Combinations: Strategic partnerships integrating ezetimibe with statins or PCSK9 inhibitors could rejuvenate sales.
• Potential New Indications: Successful expansion into niche indications, such as NASH or inflammatory diseases, could diversify revenue streams.

Based on current trends, analysts project a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, primarily fueled by volume expansion and price erosion stabilizing.

Strategic Considerations for Stakeholders

• For Branded Manufacturers: Emphasize brand loyalty through clinical support and differentiated formulations to maintain market share amid generic competition.
• For Generics Producers: Leverage existing patents post-expiry to optimize cost leadership and expand into emerging markets.
• For Investors: Monitor regulatory decisions concerning new indications and partnership announcements that could influence revenue trajectories.

Key Takeaways

• Ezetimibe's market is characterized by maturity in developed countries and significant growth prospects in emerging markets.
• Patent expiries have precipitated a shift toward generics, reducing unit prices but expanding accessible patient populations.
• The drug's role as part of combination therapies sustains its relevance; potential future indications could further diversify its financial profile.
• Competitive pressures necessitate strategic adaptations, including innovation in formulations and strategic alliances.
• Continued emphasis on cardiovascular disease prevention and management policies will underpin demand growth.

FAQs

1. How has patent expiration affected ezetimibe’s market share?
Patent expiration in 2016 led to a surge in generic manufacturing, resulting in increased sales volume but decreased profit margins for branded formulations. The overall market shifted towards affordability, enabling broader access, especially in developing economies.

2. Are there new therapeutic indications for ezetimibe under investigation?
Yes. Recent clinical studies explore ezetimibe's anti-inflammatory and hepatoprotective properties, especially concerning NASH. However, regulatory approvals for these indications are pending, and they are not yet mainstream.

3. How does ezetimibe compare to newer lipid-lowering therapies in terms of market growth?
While PCSK9 inhibitors like evolocumab and alirocumab target refractory cases, ezetimibe remains the first-line add-on therapy due to its cost-effectiveness, proven safety, and established clinical role. Its growth is thus more stable, limited by market saturation but supported by global disease burden.

4. Which regions are driving future ezetimibe sales?
Emerging markets in Asia, Latin America, and Africa are expected to contribute significantly to future sales due to expanding healthcare infrastructure, increasing prevalence of cardiovascular diseases, and greater treatment accessibility.

5. What strategic opportunities exist for stakeholders in the ezetimibe market?
Opportunities include developing combination formulations, expanding into new indications, capitalizing on emerging markets, and enhancing patient adherence through improved formulations.

References

[1] Sabatine MS, et al. (2015). Ezetimibe Added to Statin Therapy and Cardiovascular Events. New England Journal of Medicine.
[2] IQVIA. (2022). Global Sales Data for Lipid-Lowering Agents.
[3] U.S. Patent and Trademark Office. (2016). Ezetimibe Patent Expiry Timeline.
[4] World Health Organization. (2021). Cardiovascular Diseases Fact Sheet.