LIPTRUZET Drug Patent Profile

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

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

The generic ingredient in LIPTRUZET is atorvastatin calcium; ezetimibe. There are sixty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atorvastatin calcium; ezetimibe profile page.

Summary for LIPTRUZET

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIPTRUZET
DailyMed Link:	LIPTRUZET at DailyMed

US Patents and Regulatory Information for LIPTRUZET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013		DISCN	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013		DISCN	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013		DISCN	Yes	No
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013		DISCN	Yes	No

Expired US Patents for LIPTRUZET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	5,969,156*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,969,156*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013	5,969,156*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	5,686,104*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013	5,846,966*PED

International Patents for LIPTRUZET

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

Country	Patent Number	Title	Estimated Expiration
Australia	725424
Denmark	0848705
Netherlands	300132
Peru	1898	ACIDO CRISTALINO [R-(R ,R )]-2-(4-FLUOROFENIL)-�-�-DIHIDROXI-5-(1-METILETIL)-3-FENIL-4-[(FENILAMINO) CARBONIL]-1H-PIRROL-1-HEPTANOICO SAL DE CALCIO(2:1)
South Korea	100389518

Supplementary Protection Certificates for LIPTRUZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0720599	SPC001/2005	Ireland		SPC001/2005: 20050803, EXPIRES: 20190401
0720599	SZ 26/2005	Austria
1003503	SZ 30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN

Market Dynamics and Financial Trajectory of LIPTRUZET (Ezetimibe and Atorvastatin)

Introduction

LIPTRUZET, a combination drug containing ezetimibe and atorvastatin, was approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia. This article delves into the market dynamics and financial trajectory of LIPTRUZET, examining its clinical efficacy, market positioning, pricing dynamics, and financial implications.

Clinical Efficacy and Approval

LIPTRUZET combines the cholesterol-lowering effects of ezetimibe, which inhibits cholesterol absorption in the digestive tract, and atorvastatin, a statin that reduces cholesterol production in the liver. Clinical trials demonstrated significant LDL cholesterol reductions with LIPTRUZET. In a 12-week multicenter, double-blind, placebo-controlled study, LIPTRUZET reduced LDL cholesterol by 53% to 61% across different doses, outperforming atorvastatin alone[1][2].

Market Positioning

LIPTRUZET was positioned as an adjunct to diet for patients who could not achieve recommended LDL cholesterol levels with diet alone or with atorvastatin monotherapy. It targeted patients with primary or mixed hyperlipidemia and those with homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder characterized by extremely high LDL cholesterol levels[1].

Competitive Landscape

The anti-cholesterol market is highly competitive, dominated by statins and other lipid-lowering therapies. At the time of its approval, LIPTRUZET faced competition from established statins like atorvastatin (Lipitor) and other combination therapies. However, its unique dual-action mechanism provided a competitive edge by offering greater LDL cholesterol reductions compared to atorvastatin alone[1][2].

Pricing Dynamics

The pricing of LIPTRUZET was influenced by several factors, including the pricing structure of the anti-cholesterol market, the presence of generics, and the role of pharmacy benefit managers (PBMs). The introduction of generic atorvastatin in 2011 significantly impacted the market, leading to a decline in brand-name statin expenditures. Despite this, LIPTRUZET maintained a premium pricing due to its patented combination and clinical benefits[4][5].

Financial Performance

The financial performance of LIPTRUZET was closely tied to its market acceptance and the overall dynamics of the anti-cholesterol market. While specific financial data for LIPTRUZET is not publicly detailed, the drug's approval and market positioning suggested potential for significant revenue. However, the impact of generic competition and pricing pressures from PBMs and other market intermediaries likely influenced its financial trajectory.

Revenue and Market Share

LIPTRUZET's revenue was expected to be substantial given its efficacy and the large patient population with hyperlipidemia. However, the market share was likely limited by the availability of generic alternatives and the competitive landscape. By 2022, generic statins, including atorvastatin, dominated the market, capturing nearly 100% of prescriptions and over 95% of expenditures in the US Medicaid population[5].

Pricing and Cost Considerations

The pricing of LIPTRUZET was higher than that of generic atorvastatin, reflecting its patented status and clinical benefits. However, this premium pricing was subject to negotiations with PBMs and other intermediaries, which could reduce net prices. The study by Josh Feng highlights that PBMs play a crucial role in drug pricing, often excluding drugs from formularies to control costs, which can impact the financial performance of branded drugs like LIPTRUZET[4].

Adverse Effects and Safety Profile

While LIPTRUZET demonstrated strong efficacy, it also came with potential adverse effects, including increased liver enzymes (ALT and AST) and musculoskeletal pain. These side effects, although manageable, could influence patient compliance and overall market acceptance[1][2].

Regulatory and Patent Landscape

LIPTRUZET's approval was a significant milestone for Merck, but its patent protection was limited. The drug's components, ezetimibe and atorvastatin, had existing patents, and the combination's patent life was tied to these individual components. As patents expire, generic competition increases, which can erode the market share and revenue of branded drugs like LIPTRUZET.

Market Trends and Future Outlook

The anti-cholesterol market continues to evolve with new therapies and generic entries. The trend towards generic statins has significantly reduced expenditures on brand-name statins. For LIPTRUZET, the future outlook is influenced by these market trends, the availability of generic alternatives, and the emergence of new lipid-lowering therapies.

Generic Competition

The introduction of generic ezetimibe and atorvastatin has further intensified competition in the market. Generic versions of these drugs offer similar efficacy at a lower cost, making them more attractive to patients and payers. This competition is likely to continue eroding the market share and revenue of LIPTRUZET[5].

New Therapies

The development of new lipid-lowering therapies, such as PCSK9 inhibitors and other novel agents, also impacts the market dynamics. These new therapies may offer additional treatment options for patients, potentially reducing the reliance on combination drugs like LIPTRUZET.

Key Takeaways

• Clinical Efficacy: LIPTRUZET demonstrated significant LDL cholesterol reductions in clinical trials.
• Market Positioning: It was positioned as an adjunct to diet for patients with primary or mixed hyperlipidemia and HoFH.
• Pricing Dynamics: The drug's pricing was influenced by the competitive landscape, generic competition, and PBMs.
• Financial Performance: Revenue was impacted by market acceptance, generic competition, and pricing pressures.
• Regulatory and Patent Landscape: Patent protection was limited, and generic competition has increased since the patent expirations.
• Future Outlook: The market is evolving with new therapies and generic entries, which will continue to influence LIPTRUZET's market share and revenue.

FAQs

What is LIPTRUZET used for?

LIPTRUZET is used for the treatment of elevated LDL cholesterol in patients with primary or mixed hyperlipidemia as an adjunct to diet when diet alone is not enough. It is also indicated for patients with homozygous familial hypercholesterolemia (HoFH)[1].

How does LIPTRUZET work?

LIPTRUZET works by inhibiting the absorption of cholesterol in the digestive tract through ezetimibe and reducing the production of cholesterol in the liver through atorvastatin[1].

What were the clinical trial results for LIPTRUZET?

Clinical trials showed that LIPTRUZET reduced LDL cholesterol by 53% to 61% across different doses, outperforming atorvastatin alone. In a six-week study, LIPTRUZET 10/40 mg further lowered LDL cholesterol by an average of 27% compared to atorvastatin 80 mg[1][2].

What are the potential side effects of LIPTRUZET?

Potential side effects include increased liver enzymes (ALT and AST) and musculoskeletal pain[1][2].

How has generic competition affected LIPTRUZET?

Generic competition, particularly from generic ezetimibe and atorvastatin, has significantly reduced the market share and revenue of LIPTRUZET. Generic statins now dominate the market, capturing nearly 100% of prescriptions and over 95% of expenditures in the US Medicaid population[5].

What is the future outlook for LIPTRUZET?

The future outlook is influenced by market trends, generic competition, and the emergence of new lipid-lowering therapies. As generic alternatives become more prevalent and new therapies are developed, LIPTRUZET's market share and revenue are likely to continue declining.