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, and Dr Reddys Labs Sa, and is included in twenty-six 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-eight suppliers are listed for this compound.

Summary for ezetimibe

International Patents:	235
US Patents:	3
Tradenames:	5
Applicants:	21
NDAs:	26
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	349
Patent Applications:	6,424
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
Nykøbing Falster County Hospital	N/A
Steno Diabetes Center Odense	N/A
Hillerod Hospital, Denmark	N/A

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
Watson Labs Inc	EZETIMIBE	ezetimibe	TABLET;ORAL	200831-001	Jun 12, 2017	AB	RX	No	No
Teva Pharms Usa	EZETIMIBE	ezetimibe	TABLET;ORAL	078724-001	Jun 12, 2017		DISCN	No	No
Apotex	EZETIMIBE	ezetimibe	TABLET;ORAL	208332-001	Jun 12, 2017		DISCN	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
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002

International Patents for ezetimibe

Country	Patent Number	Title	Estimated Expiration
New Zealand	542090	Combinations of sterol absorption inhibitor(s) with blood modifier(s) for treating vascular conditions
European Patent Office	1864680
Japan	2009286801	METHOD OF TREATING OR PREVENTING VASCULAR INFLAMMATION USING STEROL ABSORPTION INHIBITOR

Supplementary Protection Certificates for ezetimibe

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	300689	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912

Ezetimibe Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Ezetimibe

Introduction to Ezetimibe

Ezetimibe is a medication used to lower cholesterol levels, particularly low-density lipoprotein (LDL) cholesterol, often in combination with statins or as a monotherapy. It works by inhibiting the absorption of cholesterol in the small intestine.

Global Market Size and Growth

The global ezetimibe market is projected to experience significant growth over the coming years. As of 2024, the market size is forecasted to be worth approximately USD 383.82 billion, with expectations to reach USD 571.6 billion by 2032, growing at a compound annual growth rate (CAGR) of 5.8%[1][4].

Key Market Segments

The ezetimibe market is segmented based on several criteria:

By Type

• The market is classified into different types, including 10 mg tablets and other formulations. The availability of generic ezetimibe has significantly impacted the market, with generic versions becoming increasingly popular due to their lower cost[3][5].

By Application

• Ezetimibe is used in various applications, including treatment for adults and children (10-17 years). The use of ezetimibe in combination with statins or as monotherapy is also a key segment[1].

By Geography

• North America is currently the leading region in the ezetimibe market, driven by a large population and high demand for cholesterol-lowering medications[1].

Driving Factors

Several factors are driving the growth of the ezetimibe market:

Rising Demand for Enhanced LDL Reduction

• The increasing need for effective LDL reduction, especially in high-risk individuals, is a significant driver. Ezetimibe's ability to reduce LDL cholesterol levels when used alone or in combination with statins makes it a preferred choice[1].

Statin Intolerance

• Many patients are intolerant to statins, which has led to an increased demand for alternative or complementary treatments like ezetimibe. The CLEAR Outcomes Study by Esperion, focusing on statin-intolerant patients, highlights this trend[2].

Focus on High-Risk Individuals

• There is a growing focus on managing cardiovascular risk in high-risk individuals, which includes the use of ezetimibe to achieve better LDL-C targets[2][3].

Prescription Trends

Monotherapy vs. Fixed-Dose Combinations (FDCs)

• Between 2012 and 2021, ezetimibe prescriptions as monotherapy increased significantly, with a 424% increase. In contrast, statin-ezetimibe FDC prescriptions saw only a minor increase of 29% during the same period. The availability of generic ezetimibe in 2018 contributed to this trend[3].

Geographic and Specialty Variations

• Prescription rates vary by geographic region and specialty of the prescribing physician. Specialists tend to prescribe statin-ezetimibe FDCs more frequently than general practitioners[3].

Financial Performance of Key Players

Esperion

• Esperion, a company that markets NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe), reported significant growth in 2021. U.S. net product revenue for these products grew 12% sequentially to $12.2 million in the fourth quarter of 2021 and over 200% for the full year. Despite net losses, the company strengthened its balance sheet and extended its cash runway beyond the expected outcomes of the CLEAR trial[2].

Market Outlook and Projections

Revenue Growth

• The ezetimibe market is expected to continue its upward trajectory, driven by increasing demand and the expanding use of generic versions. The market size is projected to grow from USD 383.82 billion in 2024 to USD 571.6 billion by 2032[1].

Competitive Landscape

• The market is competitive, with key players including Merck & Co. Inc., Sun Pharmaceutical Industries Ltd., Mylan N.V., and others. These companies are focusing on expanding their product portfolios and geographic presence to capture a larger market share[5].

Challenges and Opportunities

Cost and Generic Availability

• The availability of generic ezetimibe has significantly reduced the cost per defined daily dose (DDD), making it more accessible to patients. This trend is expected to continue, driving market growth[3].

Regulatory and Clinical Trials

• Ongoing clinical trials, such as the CLEAR Outcomes Study, are crucial for demonstrating the efficacy of ezetimibe in improving cardiovascular outcomes. Positive outcomes from these trials can further boost market demand[2].

Key Takeaways

• The global ezetimibe market is projected to grow significantly, driven by increasing demand for effective LDL reduction and the rising intolerance to statins.
• The market is segmented by type, application, and geography, with North America being the leading region.
• Prescription trends show a significant increase in ezetimibe monotherapy prescriptions compared to statin-ezetimibe FDCs.
• Key players like Esperion are focusing on strengthening their financial positions and expanding their market presence.
• The availability of generic ezetimibe and positive clinical trial outcomes are expected to drive market growth.

FAQs

What is the projected market size of the ezetimibe market by 2032?

The global ezetimibe market is expected to reach USD 571.6 billion by 2032, growing at a CAGR of 5.8% from 2024[1].

Which region is leading the ezetimibe market?

North America is currently the leading region in the ezetimibe market due to its large population and high demand for cholesterol-lowering medications[1].

What are the driving factors for the ezetimibe market?

The driving factors include the rising demand for enhanced LDL reduction, statin intolerance, and a focus on high-risk individuals[1][2].

How have prescription trends for ezetimibe changed over the years?

Ezetimibe prescriptions as monotherapy have increased significantly, while statin-ezetimibe FDC prescriptions have seen only a minor increase between 2012 and 2021[3].

Which companies are key players in the ezetimibe market?

Key players include Merck & Co. Inc., Sun Pharmaceutical Industries Ltd., Mylan N.V., and others, along with Esperion for its combination products[2][5].

Sources

1. The Market Intelligence: Ezetimibe Market Size, Share | Global Research [2032]
2. Esperion: Esperion Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Company Update
3. Frontiers in Cardiovascular Medicine: Trends in Ezetimibe Prescriptions as Monotherapy or Fixed-Dose Combinations
4. Dataintelo: Ezetimibe Market Research Report 2032
5. Market Research Intellect: Ezetimibe and Simvastatin Sales Market Size, Scope And Forecast