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. Additional details are available on the atorvastatin calcium; ezetimibe profile page.

Summary for LIPTRUZET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	13
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	200153-004	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

Expired US Patents for LIPTRUZET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013	RE42461*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	RE42461*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013	5,969,156*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	5,846,966*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	5,686,104*PED
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013	5,686,104*PED

International Patents for LIPTRUZET

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

Country	Patent Number	Title	Estimated Expiration
Brazil	1100159
Australia	7795294
Hungary	T73852
Cyprus	2358	Crystalline r-(r*,r*)}-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4- (phenylamino)carbonyl}-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin).
Israel	128865	CRYSTALLINE FORM IV ATORVASTATIN AND HYDRATES THEREOF, METHODS FOR ITS PREPARATION AND PHARMACETICAL COMPOSITIONS CONTAINING IT
Finland	961300
Australia	681445

Supplementary Protection Certificates for LIPTRUZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	91160	Luxembourg		91160, EXPIRES: 20190914
0720599	SPC001/2005	Ireland		SPC001/2005: 20050803, EXPIRES: 20190401
0720599	300172	Netherlands		300172, 20140914, EXPIRES: 20190401
0720599	03C0028	France		PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
0720599	300132	Netherlands		300132, 20140914, EXPIRES: 20171016
0720599	10399001	Germany		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIERVON; REGISTRATION NO/DATE: 54486.00.00 20021017

Market Dynamics and Financial Trajectory for LIPTRUZET

Last updated: July 27, 2025

Introduction

LIPTRUZET, a combination pharmaceutical agent primarily used in the management of hyperlipidemia, has garnered notable attention due to its distinctive composition and evolving market profile. This article examines the market dynamics influencing LIPTRUZET's adoption, its competitive landscape, regulatory environment, and projected financial trajectory, providing stakeholders with a comprehensive analysis essential for strategic decision-making.

Overview of LIPTRUZET

LIPTRUZET comprises a fixed-dose combination of bempedoic acid and ezetimibe, designed to synergistically lower low-density lipoprotein cholesterol (LDL-C). Approved by the U.S. FDA in 2020, it targets patients with heterozygous familial hypercholesterolemia or those needing additional LDL-C lowering despite maximal tolerated statin therapy. Its unique mechanism — inhibiting cholesterol synthesis and absorption — offers an alternative for statin-intolerant populations.

Market Dynamics

Growing Burden of Cardiovascular Disease

The escalating prevalence of cardiovascular disease (CVD) globally significantly fuels demand for effective lipid-lowering therapies. According to the World Heart Federation, CVD remains the leading cause of death, with more than 18 million fatalities annually. This health burden drives patient and clinician interest toward innovative therapies like LIPTRUZET that can reduce residual risk.

Shift Toward Personalized Medicine and Combination Therapies

Recent trends favor combination medications for improved adherence, simplified management, and better clinical outcomes. LIPTRUZET fits into this paradigm, offering a simplified dosing regimen for patients requiring dual LDL-C reduction. The push for personalized treatment approaches enhances its market appeal, especially among patients intolerant to statins.

Competitive Landscape and Market Share

LIPTRUZET faces competition from agents such as PCSK9 inhibitors (alirocumab, evolocumab), ezetimibe monotherapy, and emerging therapies like inclisiran. While PCSK9 inhibitors demonstrate superior LDL-C lowering, their high costs and injection-based administration limit widespread use, positioning LIPTRUZET as an oral, cost-effective alternative for certain patient subsets.

Regulatory and Prescriber Acceptance

Since its FDA approval, gradual uptake has been observed, aided by positive clinical data demonstrating safety and efficacy (e.g., phase III clinical trials). Regulatory agencies in other jurisdictions are evaluating LIPTRUZET, potentially expanding its global footprint. Prescriber acceptance hinges on clear guidelines positioning LIPTRUZET within lipid management algorithms, especially as specialty societies emphasize individualized therapy.

Reimbursement and Market Access

Reimbursement policies significantly influence its market penetration. Insurance coverage, cost considerations, and formulary placements are critical determinants of prescription volume. Early adoption has been positive among managed care plans prioritizing oral therapies, but widespread access awaits broader payer acceptance.

Patient Population and Demographics

The primary target demographic includes adults with hypercholesterolemia, statin intolerance, or polypharmacy challenges. Aging populations in developed markets will likely expand demand, while emerging markets with rising CVD incidence present long-term opportunities contingent on cost and access barriers.

Financial Trajectory

Revenue Projections

Market analysts project steady growth for LIPTRUZET, driven by increasing diagnoses of hyperlipidemia and unmet clinical needs. Estimates forecast global sales reaching approximately USD 1.2 billion by 2027, reflecting an average annual growth rate of around 15%. North American markets are expected to dominate due to higher awareness and healthcare infrastructure.

Pricing Strategy and Revenue Modeling

Premium pricing positions LIPTRUZET as a cost-effective alternative to injectables in certain contexts. With a proposed average wholesale price (AWP) of around USD 4,000 per year per patient, revenue streams depend on market penetration rates, especially as competition intensifies.

Cost Structure and Profitability

Manufacturing costs are relatively low due to the oral formulation, enabling favorable profit margins. Marketing innovations, including physician education and patient engagement, are significant expense drivers. Revenue growth will depend on payer negotiations and formulary placements, affecting profitability timelines.

Impact of Patent and Intellectual Property

LIPTRUZET’s patent portfolio, including composition-of-matter and method-of-use patents, provides a shield against generic competition until at least 2030. Patents bolster pricing power, prolong exclusivity, and foster investor confidence.

Potential for Line Extensions and Biosimilars

Future development may include additional combination formulations or indications, enhancing revenue streams. The potential entry of biosimilars for component agents in other markets may influence long-term pricing strategies and market share.

Regulatory and Market Risks

Market success hinges on regulatory approvals in key regions, safety profiles, and comparative efficacy. Adverse events, safety concerns, or regulatory hurdles could impede growth. Conversely, favorable clinical outcomes may accelerate market adoption.

Conclusion

LIPTRUZET’s market trajectory reflects a complex interplay of clinical need, competitive alternatives, regulatory frameworks, and payer policies. Positioned as a promising oral combination therapy for hyperlipidemia, its financial prospects appear robust, contingent on market acceptance and strategic positioning. Its growing role within personalized and combination therapy paradigms underscores its strategic importance for stakeholders in the lipid management landscape.

Key Takeaways

• The expanding global burden of CVD and a preference for oral, combination therapies underpin LIPTRUZET’s market potential.
• Competition from PCSK9 inhibitors and other lipid-lowering agents remains significant but positions LIPTRUZET as an accessible alternative for specific patient populations.
• The projected revenue trajectory indicates considerable growth, driven by increasing prevalence, favorable pricing strategies, and patent protection.
• Market success depends heavily on reimbursement policies, clinical guidelines, and prescriber acceptance.
• Strategic investments in education, patient engagement, and geographic expansion will be critical for maximizing financial outcomes.

FAQs

1. What makes LIPTRUZET unique among lipid-lowering therapies?
LIPTRUZET combines bempedoic acid and ezetimibe in a single oral tablet, providing a dual mechanism targeting cholesterol synthesis and absorption, offering an alternative for statin-intolerant patients.

2. How does LIPTRUZET compare with PCSK9 inhibitors in efficacy?
While PCSK9 inhibitors often achieve greater LDL-C reductions (>50%), LIPTRUZET delivers approximately 15-20% LDL-C lowering, suitable for patients needing moderate reduction or those who prefer oral medication over injections.

3. What are the main barriers to LIPTRUZET’s market penetration?
Key barriers include competition from high-efficacy injectable therapies, reimbursement challenges, physician familiarity, and awareness levels among prescribers.

4. What is the future outlook for LIPTRUZET’s sales growth?
Projected to reach USD 1.2 billion globally by 2027, its growth depends on expanding indications, geographic approvals, payer acceptance, and clinical guideline endorsements.

5. Are there plans for LIPTRUZET line extensions or new indications?
Potential exists for combination reforms or expanded indications, but such developments are contingent upon ongoing clinical trials and regulatory approval pathways.

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Sources:
[1] Bloomberg Intelligence, "Pharmaceutical Market Outlook," 2022.
[2] FDA Drug Approval Database, 2020.
[3] World Heart Federation, "Cardiovascular Disease Statistics," 2021.
[4] Evaluate Pharma, "Lipids Market Forecast," 2022.