VYTORIN Drug Patent Profile

When do Vytorin patents expire, and what generic alternatives are available?

Vytorin is a drug marketed by Organon and is included in one NDA.

The generic ingredient in VYTORIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vytorin

A generic version of VYTORIN was approved as ezetimibe; simvastatin by DR REDDYS LABS SA on April 26^th, 2017.

Summary for VYTORIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	41
Patent Applications:	206
Drug Prices:	Drug price information for VYTORIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYTORIN
What excipients (inactive ingredients) are in VYTORIN?	VYTORIN excipients list
DailyMed Link:	VYTORIN at DailyMed

See drug prices for VYTORIN

See drug sales revenues for VYTORIN

Recent Clinical Trials for VYTORIN

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

Sponsor	Phase
Samsung Medical Center	Phase 4
Cairo University	N/A
Aswan Heart Centre	N/A

See all VYTORIN clinical trials

Pharmacology for VYTORIN

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

Paragraph IV (Patent) Challenges for VYTORIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYTORIN	Tablets	ezetimibe; simvastatin	10 mg/10 mg 10 mg/20 mg 10 mg/40 mg 10 mg/80 mg	021687	1	2009-07-27

US Patents and Regulatory Information for VYTORIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004	AB	RX	Yes	No
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004	AB	RX	Yes	Yes
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004	AB	RX	Yes	No
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	AB	RX	Yes	No

Expired US Patents for VYTORIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-002	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004

International Patents for VYTORIN

See the table below for patents covering VYTORIN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	393628
Poland	375065	Kompozycja inhibitora wchłaniania cholesterolu, inhibitora reduktazy HMG-CoA i środka stabilizującego (COMPOSITION COMPRISING A CHOLESTEROL ABSORPTION INHIBITOR, AN HMG-COA REDUCTASE INHIBITOR AND A STABILIZING AGENT)
European Patent Office	0033538	6(R)-(2-(8'-ACYLOXY-2'-METHYL-6'-METHYL (OR HYDROGEN)-POLYHYDRONAPHTHYL-1')-ETHYL)-4(R)-HYDROXY-3,4,5,6-TETRAHYDRO-2H-PYRAN-2-ONES, THE HYDROXY ACID FORM OF SAID PYRANONES, THE PHARMACEUTICALLY ACCEPTABLE SALTS OF SAID HYDROXY ACIDS, AND THE LOWER ALKYL, AND PHENYL, DIMETHYLAMINO OR ACETYLAMINO SUBSTITUTED LOWER ALKYL ESTERS OF SAID HYDROXY ACID, PROCESSES FOR PREPARING THE SAME, AND A PHARMACEUTICAL ANTIHYPERCHOLESTEROLEMIC COMPOSITION CONTAINING THE SAME
Eurasian Patent Organization	200500279	КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ИНГИБИТОР АБСОРБЦИИ ХОЛЕСТЕРИНА, ИНГИБИТОР HMG-COA-РЕДУКТАЗЫ И СТАБИЛИЗИРУЮЩИЙ АГЕНТ

Supplementary Protection Certificates for VYTORIN

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	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	92545	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
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

VYTORIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: VYTORIN

Introduction

VYTORIN, a combination drug of ezetimibe and simvastatin, is a significant player in the market for treating high cholesterol and reducing cardiovascular risk. Here, we will delve into the market dynamics and financial trajectory of VYTORIN, highlighting its effectiveness, market performance, and financial impact.

Effectiveness of VYTORIN

VYTORIN has been proven effective in several clinical studies for treating high cholesterol and reducing cardiovascular events.

Clinical Studies

In a 12-week study, VYTORIN demonstrated superior efficacy compared to its individual components, simvastatin and ezetimibe, and a placebo. The study showed that VYTORIN reduced total cholesterol by 38%, LDL cholesterol by 53%, triglycerides by 24%, and increased HDL cholesterol by 7%[1].

The IMPROVE-IT study, involving over 18,000 patients with acute coronary syndromes, further reinforced VYTORIN's benefits. It showed that VYTORIN reduced total cardiovascular events by 9% compared to simvastatin alone, including a 6.4% reduction in initial events and a 12% reduction in recurrent events[4].

Market Performance

VYTORIN's market performance is closely tied to its efficacy and the demand for cholesterol-lowering medications.

Sales and Revenue

VYTORIN is part of Merck's (known as MSD outside the U.S. and Canada) pharmaceutical portfolio. While specific sales figures for VYTORIN are not always detailed separately, it contributes to the overall revenue of Merck's cardiovascular division.

In 2007, Merck's cardiovascular products, including VYTORIN, played a significant role in offsetting revenue declines from other products. The company's pharmaceutical sales, which include VYTORIN, were $19.6 billion in 2007[3].

Competitive Landscape

VYTORIN competes in a crowded market with other statins and cholesterol-lowering drugs. However, its combination of ezetimibe and simvastatin offers a unique advantage, as seen in clinical studies. The drug's performance in reducing both initial and recurrent cardiovascular events positions it favorably against competitors like rosuvastatin (Crestor)[1][4].

Financial Trajectory

Merck's financial performance provides insight into the economic impact of VYTORIN.

Annual Sales and Revenue

Merck's overall pharmaceutical sales have shown steady growth. In 2018, Merck's worldwide sales were $42.3 billion, a 5% increase from 2017. While VYTORIN's specific sales are not detailed, the growth in Merck's pharmaceutical segment indicates a positive financial trajectory for the drug[2].

Profitability and Shareholder Returns

Merck's profitability and shareholder returns are also indicative of the financial health of its products, including VYTORIN. In 2018, Merck returned $14 billion to shareholders through share repurchases and dividends, reflecting the company's strong financial position[2].

Research and Development

Merck continues to invest in research and development, which includes further studies and analyses on VYTORIN. The IMPROVE-IT study, for example, was a significant investment that provided valuable data on VYTORIN's efficacy in reducing cardiovascular events[4].

Regulatory and Safety Considerations

VYTORIN's market dynamics are also influenced by regulatory and safety considerations.

FDA Approval and Safety Profile

VYTORIN is FDA-approved for treating high cholesterol in adults and children aged 10 and older. However, it comes with certain safety warnings, such as the risk of myopathy and rhabdomyolysis, especially when combined with strong CYP3A4 inhibitors[1][4].

Market Trends and Future Outlook

The market for cholesterol-lowering medications is driven by increasing awareness of cardiovascular health and the need for effective treatments.

Growing Demand for Cardiovascular Treatments

The demand for drugs like VYTORIN is expected to grow as the global population ages and the prevalence of cardiovascular diseases increases. Clinical studies like IMPROVE-IT continue to support the use of VYTORIN in high-risk patients, which could further boost its market presence[4].

Competitive Innovations

The pharmaceutical industry is highly competitive, with continuous innovation in cardiovascular treatments. VYTORIN's unique combination and proven efficacy will need to be maintained or improved to stay competitive in the market.

Key Takeaways

• Clinical Efficacy: VYTORIN has been shown to be highly effective in reducing cholesterol levels and cardiovascular events.
• Market Performance: The drug contributes significantly to Merck's pharmaceutical revenue, although specific figures are not always detailed.
• Financial Trajectory: Merck's overall financial performance indicates a positive trajectory for VYTORIN, with strong sales and profitability.
• Regulatory and Safety: VYTORIN is FDA-approved but comes with specific safety warnings.
• Market Trends: The demand for effective cholesterol-lowering medications is expected to grow, supporting VYTORIN's market presence.

FAQs

What is VYTORIN used for?

VYTORIN is used to treat high cholesterol caused by primary hyperlipidemia in adults and children aged 10 and older.

How effective is VYTORIN in reducing cholesterol?

VYTORIN reduces total cholesterol by an average of 38%, LDL cholesterol by 53%, triglycerides by 24%, and increases HDL cholesterol by 7% in clinical studies[1].

What are the key findings of the IMPROVE-IT study?

The IMPROVE-IT study showed that VYTORIN reduced total cardiovascular events by 9% compared to simvastatin alone, including a 6.4% reduction in initial events and a 12% reduction in recurrent events[4].

What are the potential side effects of VYTORIN?

VYTORIN can cause myopathy, rhabdomyolysis, and other muscle-related issues, especially when combined with strong CYP3A4 inhibitors[1][4].

How does VYTORIN compare to other cholesterol-lowering medications?

VYTORIN's combination of ezetimibe and simvastatin offers unique benefits, particularly in reducing both initial and recurrent cardiovascular events, positioning it favorably against competitors like rosuvastatin (Crestor)[1][4].

Sources

1. Medical News Today: Vytorin: Side effects, uses, dosage, interactions, and more.
2. Merck: Merck Announces Fourth-Quarter and Full-Year 2018 Financial Results.
3. Annual Reports: Merck & Co., Inc. - Annual Reports.
4. Merck: New Analysis from Investigational IMPROVE-IT Study Shows VYTORIN® (ezetimibe/simvastatin) Reduced Total (Initial and Recurrent) Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes.