LIVALO Drug Patent Profile

When do Livalo patents expire, and when can generic versions of Livalo launch?

Livalo is a drug marketed by Kowa Co and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in seventeen countries.

The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pitavastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Livalo

A generic version of LIVALO was approved as pitavastatin calcium by AUROBINDO PHARMA on December 20^th, 2016.

Summary for LIVALO

International Patents:	53
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	23
Patent Applications:	4,387
Drug Prices:	Drug price information for LIVALO
Drug Sales Revenues:	Drug sales revenues for LIVALO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIVALO
What excipients (inactive ingredients) are in LIVALO?	LIVALO excipients list
DailyMed Link:	LIVALO at DailyMed

See drug prices for LIVALO

See drug sales revenues for LIVALO

Recent Clinical Trials for LIVALO

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Amgen	Phase 4
HealthCore-NERI	Phase 3

See all LIVALO clinical trials

Pharmacology for LIVALO

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Paragraph IV (Patent) Challenges for LIVALO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIVALO	Tablets	pitavastatin calcium	1 mg, 2 mg, and 4 mg	022363	7	2013-08-05

US Patents and Regulatory Information for LIVALO

LIVALO is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No					Y
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	No					Y
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No					Y

Expired US Patents for LIVALO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009

International Patents for LIVALO

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004072040
South Korea	960000852
European Patent Office	1715865	AGENT THERAPEUTIQUE CONTRE L HYPERLIPÉMIE CONTENANT DES PITAVASTATINES ET L'ACIDE EICOSAPENTAÉNOÏQUE (HYPERLIPEMIA THERAPEUTIC AGENT COMPRISING PITAVASTATINS AND EICOSAPENTAENOIC ACID)

LIVALO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIVALO (Pitavastatin)

Introduction to LIVALO (Pitavastatin)

LIVALO, known generically as pitavastatin, is a statin medication used to lower low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia. Here, we delve into the market dynamics and financial trajectory of this crucial cardiovascular medication.

Market Size and Growth Projections

The global pitavastatin market, which includes LIVALO, is anticipated to experience significant growth. By 2023, the market size was valued at approximately USD 516.6 million and is projected to reach USD 910.6 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.5% from 2023 to 2032[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the pitavastatin market:

Increasing Cardiovascular Disease Prevalence

The rising global burden of cardiovascular diseases, including hyperlipidemia, is a primary driver. Growing awareness of the importance of cholesterol management contributes to increased demand for lipid-lowering medications like LIVALO[1][4].

Advancements in Pharmaceutical Formulations

Ongoing research and development have led to innovations in pitavastatin formulations, such as more convenient dosage forms and optimized release profiles. These enhancements improve patient adherence and treatment outcomes[1][4].

Focus on Preventive Healthcare

A shift towards preventive healthcare measures and an emphasis on cardiovascular risk reduction contribute to the growing adoption of pitavastatin. Healthcare providers increasingly prescribe these medications for individuals at risk of cardiovascular events[1][4].

Expanding Geriatric Population

The aging population is more prone to cardiovascular conditions, driving the demand for medications like LIVALO. As the global demographic landscape shifts towards an older age group, the market for pitavastatin is likely to expand[1].

Strategic Acquisitions and Partnerships

Pharmaceutical companies engaging in strategic acquisitions and partnerships to strengthen their product portfolios and market presence also contribute to the growth of the pitavastatin market. Collaborations enable access to new markets and resources[1].

Market Segmentation

The pitavastatin market is segmented by type, product, application, and end-user.

By Type

The market is segmented into 1 mg, 2 mg, and 4 mg strengths. Recent introductions by companies like Teva and Upsher-Smith have expanded the availability of these strengths, providing cost-effective options for cholesterol management[1][4].

By Product

The market includes tablets, capsules, and oral solutions. The introduction of generic versions, such as those by Teva and Upsher-Smith, has increased the product offerings in the market[1][4].

By Application

The primary application is in managing hyperlipidemia and preventing cardiovascular diseases. Hyperlipidemia is a significant risk factor for cardiovascular diseases, making pitavastatin a crucial medication in this segment[1][4].

By End User

The market is segmented into hospitals, clinics, retail pharmacies, and online pharmacies. Hospitals serve as vital distribution channels, offering both inpatient and outpatient access to the medication[4].

Regional Market Dynamics

North America

The North America pitavastatin market holds a significant revenue share. There is a noticeable shift towards an emphasis on combination therapies, with healthcare providers recommending pitavastatin alongside other cardiovascular medications to target various risk factors[4].

Asia Pacific

The Asia Pacific region is projected to grow at a rapid rate. The integration of digital health solutions, such as telehealth services, mobile apps, and online platforms, has improved patient accessibility, adherence, and monitoring of pitavastatin prescriptions[4].

Financial Trajectory and Recent Developments

Generic Entries

In 2023, Teva introduced an AB-rated generic version of LIVALO (pitavastatin) tablets, and Upsher-Smith introduced Pitavastatin Tablets in 1mg, 2mg, and 4mg strengths. These generic entries provide cost-effective options and are expected to influence market dynamics[1].

Market Revenue and CAGR

The market is expected to grow from USD 516.6 million in 2023 to USD 910.6 million by 2032, with a CAGR of 6.5% during the forecast period[1].

Impact of Government Initiatives and Healthcare Policies

Supportive government initiatives and healthcare policies aimed at reducing the burden of cardiovascular diseases play a crucial role in driving the pitavastatin market. Policies promoting early detection, diagnosis, and effective management of hyperlipidemia contribute to increased adoption[1].

Challenges and Opportunities

Evolving Regulatory Standards

Changes in healthcare policies and reimbursement structures can impact the affordability and accessibility of pitavastatin, influencing patient access and market demand. Evolving regulatory standards and challenges associated with obtaining approvals for new formulations or indications may present obstacles[4].

Patient Education and Awareness Programs

Post-COVID, healthcare providers may initiate targeted patient education and awareness programs to highlight the importance of managing hyperlipidemia and cardiovascular health. These programs can drive increased understanding among patients, leading to higher adherence to prescribed medications like LIVALO[1].

Key Players and Competitive Landscape

The pitavastatin market includes major players such as Pfizer Inc., AstraZeneca PLC, Novartis International AG, GlaxoSmithKline plc, and Teva Pharmaceutical Industries Ltd. These companies engage in strategic acquisitions, partnerships, and research and development activities to strengthen their market presence[4].

Conclusion

The market for LIVALO (pitavastatin) is poised for significant growth driven by increasing cardiovascular disease prevalence, advancements in pharmaceutical formulations, and a focus on preventive healthcare. The introduction of generic versions and strategic partnerships are key factors influencing the market dynamics. As the global healthcare landscape continues to evolve, the demand for effective lipid-lowering medications like LIVALO is expected to rise, contributing to the market's financial trajectory.

Key Takeaways

• The global pitavastatin market is projected to reach USD 910.6 million by 2032, growing at a CAGR of 6.5% from 2023 to 2032.
• Increasing cardiovascular disease prevalence and advancements in pharmaceutical formulations are key drivers of market growth.
• The market is segmented by type, product, application, and end-user, with hospitals serving as vital distribution channels.
• North America and the Asia Pacific region are significant markets, with a focus on combination therapies and digital health solutions.
• Generic entries and strategic partnerships are influencing market dynamics.
• Government initiatives and healthcare policies play a crucial role in driving the market.

FAQs

What is LIVALO (pitavastatin) used for?

LIVALO (pitavastatin) is used to lower low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.

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

The global pitavastatin market is projected to reach USD 910.6 million by 2032[1].

What are the key drivers of the pitavastatin market growth?

Key drivers include increasing cardiovascular disease prevalence, advancements in pharmaceutical formulations, focus on preventive healthcare, and an expanding geriatric population[1][4].

Who are the major players in the pitavastatin market?

Major players include Pfizer Inc., AstraZeneca PLC, Novartis International AG, GlaxoSmithKline plc, and Teva Pharmaceutical Industries Ltd.[4].

How do generic entries impact the pitavastatin market?

Generic entries provide cost-effective options, influencing market dynamics and potentially leading to price erosion and a reduction in market share for branded pitavastatin[1][4].

Cited Sources

1. Custom Market Insights: "Global Pitavastatin Market Size Reach $910.6 Million 2032"[1].
2. LivaNova: "LivaNova Reports Fourth-Quarter and Full-Year 2023 Results"[2].
3. Harvard Scholar: "Explaining Prescription Drug Pricing Dynamics"[3].
4. InsightAce Analytic: "Pitavastatin Market Current Scenario Analysis Report 2024-2031"[4].
5. LivaNova: "LivaNova Reports Third-Quarter 2024 Results"[5].