ZETIA Drug Patent Profile

Which patents cover Zetia, and what generic alternatives are available?

Zetia is a drug marketed by Organon and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zetia

A generic version of ZETIA was approved as ezetimibe by GLENMARK PHARMS LTD on June 26^th, 2015.

Summary for ZETIA

International Patents:	235
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Patent Applications:	4,136
Drug Prices:	Drug price information for ZETIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZETIA
What excipients (inactive ingredients) are in ZETIA?	ZETIA excipients list
DailyMed Link:	ZETIA at DailyMed

See drug prices for ZETIA

See drug sales revenues for ZETIA

Pharmacology for ZETIA

Drug Class	Dietary Cholesterol Absorption Inhibitor
Physiological Effect	Decreased Cholesterol Absorption

Paragraph IV (Patent) Challenges for ZETIA

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

US Patents and Regulatory Information for ZETIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	AB	RX	Yes	Yes					Y

Expired US Patents for ZETIA

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
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002

International Patents for ZETIA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0116212
Japan	4351842
Norway	2005003
Norway	20041598
Poland	182617

Supplementary Protection Certificates for ZETIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	0390018-0	Sweden		PRODUCT NAME: EZETIMIB
0720599	C00720599/02	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
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	SPC/GB03/023	United Kingdom		PRODUCT NAME: EZETIMIBE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: DE 54486.00.00 20021017; DE 54488.00.00 20021017; DE 54487.00.00 20021017; DE 54489.00.00 20021017; UK PL 19945/0001 20030404; UK PL 19945/0002 20030404
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411

Market Dynamics and Financial Trajectory for the Drug: ZETIA

Introduction

ZETIA, a cholesterol-lowering medication developed by Merck & Co., has been a significant player in the pharmaceutical market for years. However, its market dynamics and financial trajectory have undergone substantial changes, particularly with the introduction of generic competitors and shifts in the broader cholesterol treatment landscape.

ZETIA's Peak and Exclusive Market Position

At its peak, ZETIA was a $2.5 billion seller, contributing substantially to Merck's revenue. It was often prescribed in combination with statins, such as Zocor, under the brand name Vytorin. This combination therapy was a major revenue generator for Merck, with ZETIA and Vytorin expected to haul in about $3.5 billion in 2016[1].

Generic Competition and Exclusivity Loss

The loss of exclusivity marked a significant turning point for ZETIA. In December 2016, Endo’s Par Pharmaceutical unit launched the first generic version of ZETIA, gaining a 180-day exclusivity period under FDA rules. After this period, multiple generic manufacturers entered the market, leading to a sharp decline in Merck's ZETIA sales. Analysts predicted that by 2020, the combined sales of ZETIA and Vytorin would drop to less than $1 billion[1].

Financial Impact on Merck

The introduction of generics had a profound impact on Merck's financials. The loss of ZETIA's exclusivity was expected to hit Merck's earnings significantly, with Barclays analysts noting that older products like ZETIA typically have higher margins than newer medications. Much of ZETIA's growth since 2011 had been driven by price hikes, which became unsustainable once generics entered the market[1].

Offset by Other Products

Despite the decline in ZETIA sales, Merck's overall financial performance was cushioned by the strong sales of other products, particularly Keytruda, an immuno-oncology drug. Keytruda's sales grew 30% to $14.4 billion in 2020, helping to offset the losses from ZETIA and other declining products[3].

Market Competition and Pricing Dynamics

The cholesterol-fighting market has become increasingly crowded with the introduction of PCSK9 inhibitors like Praluent and Repatha. However, these newer drugs come with high list prices, often exceeding $14,000 per year. This has led payers to prefer ZETIA or Vytorin as add-on therapies to statins before approving the more expensive PCSK9 inhibitors. This preference has somewhat stabilized the demand for ZETIA and its generics, despite the competitive landscape[1].

International Price Disparities

The pricing of ZETIA varies significantly across different regions. For instance, in 2017, ZETIA cost $10.17 per pill in the U.S., while it was available for $2.68 per pill in Turkey. Such price disparities highlight the complex global market dynamics and the impact of local regulatory and pricing strategies on pharmaceutical sales[4].

Recent Financial Performance

In recent years, Merck has continued to navigate the challenges posed by generic competition. For the first quarter of 2024, Merck reported a significant increase in sales and net income, partly due to the favorable impacts of product mix and foreign exchange. However, the company also faced charges related to ZETIA antitrust litigation settlements, which affected its non-GAAP EPS[5].

Impact of Litigation and Regulatory Changes

Merck has faced various legal and regulatory challenges related to ZETIA. For example, in 2023, the company incurred a $572.5 million charge related to settlements with certain plaintiffs in the ZETIA antitrust litigation. These charges have periodically impacted Merck's financial performance and highlighted the ongoing legal and regulatory complexities surrounding the drug[5].

Clinical Significance and FDA Decisions

Despite the financial challenges, ZETIA has shown clinical benefits in certain patient groups. The Impact-It trial demonstrated that ZETIA, when added to a statin, could reduce cardiovascular risks for patients with acute coronary syndrome. However, an FDA panel voted against updating the drug's label to include these benefits, citing the small and limited nature of the risk reduction[1].

Conclusion

The market dynamics and financial trajectory of ZETIA have been marked by significant changes, driven by the loss of exclusivity, generic competition, and shifts in the broader cholesterol treatment landscape. While ZETIA's sales have declined substantially, Merck has managed to offset these losses with the strong performance of other products like Keytruda. The ongoing competition and regulatory challenges continue to shape the financial and market outlook for ZETIA.

Key Takeaways

• ZETIA's exclusivity loss led to a significant decline in sales.
• Generic competition has reshaped the cholesterol treatment market.
• Merck's financial performance has been cushioned by strong sales of other products like Keytruda.
• Pricing dynamics and payer preferences continue to influence ZETIA's market position.
• Regulatory and legal challenges remain a factor in ZETIA's financial trajectory.

FAQs

What was the impact of generic competition on ZETIA's sales?

The introduction of generic versions of ZETIA led to a sharp decline in Merck's sales, with predictions that combined sales of ZETIA and Vytorin would drop to less than $1 billion by 2020.

How has Merck offset the decline in ZETIA sales?

Merck has offset the decline in ZETIA sales with strong sales from other products, particularly Keytruda, which saw a 30% growth to $14.4 billion in 2020.

What is the current pricing dynamic for ZETIA compared to other cholesterol treatments?

ZETIA and its generics are often preferred by payers as add-on therapies to statins due to their lower cost compared to newer PCSK9 inhibitors like Praluent and Repatha.

How have regulatory decisions impacted ZETIA's market position?

An FDA panel voted against updating ZETIA's label to include cardiovascular benefits, citing the small and limited nature of the risk reduction. This decision has affected the drug's market positioning and potential for expanded use.

What are the international price disparities for ZETIA?

ZETIA prices vary significantly internationally, with a cost of $10.17 per pill in the U.S. compared to $2.68 per pill in Turkey as of 2017.

Sources

1. FiercePharma: "Zetia generics launch sets Merck up for $1.4B hit to 2017 cholesterol sales"[1]
2. Esperion: "Esperion Reports First Quarter 2024 Financial Results"[2]
3. Merck: "Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results"[3]
4. Statista: "Price disparities for pharmaceutical product Zetia in the U.S. and abroad as of 2017"[4]
5. Merck: "Merck Announces First-Quarter 2024 Financial Results"[5]