LIVALO Drug Patent Profile

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

Livalo is a drug marketed by Kowa Co and is included in one NDA.

The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. Thirteen 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

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIVALO

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

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
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	No
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	AB	RX	Yes	Yes

International Patents for LIVALO

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

Country	Patent Number	Title	Estimated Expiration
Germany	202004021379
Japan	H01279866	QUINOLINE-BASED MEVALONOLACTONES
Poland	376557	Postacie krystaliczne pitawastatyny wapnia (CRYSTALLINE FORMS OF PITAVASTATIN CALCIUM)
Taiwan	200420541	Crystalline forms
Japan	2014055185	NOVEL AMORPHOUS FORM OF PITAVASTATIN CALCIUM
China	102285916
Hong Kong	1098953	HYPERLIPEMIA THERAPEUTIC AGENT

LIVALO Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Current Investment Outlook for LIVALO (Pitavastatin)?

LIVALO (pitavastatin) is a statin used to lower LDL cholesterol. Since its FDA approval in 2010, it has maintained a niche market share in hyperlipidemia treatment. Its positioning is primarily driven by an improved side-effect profile and efficacy compared to older statins. Market dynamics suggest moderate growth prospects given the competitive landscape, patent status, and evolving lipid management guidelines.

What Are the Market Fundamentals for LIVALO?

Market Size and Growth

The global hyperlipidemia drug market was valued at approximately USD 25 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 3-5% through 2028. Statins account for about 60% of this market, with newer agents and generics competing in the space.

Key Market Drivers

• Increasing prevalence of cardiovascular diseases (CVD): The global CVD market is expanding due to aging populations and lifestyle factors, boosting demand for lipid-lowering therapies.
• Guideline updates: ESC/EAS 2019 and ACC/AHA 2018 guidelines emphasize statin therapy for primary and secondary prevention, favoring agents with favorable profiles.
• Patent and exclusivity: LIVALO's patent estate has lapsed in multiple markets, leading to increased generic competition that pressures pricing and margins.

Competitive Landscape

LIVALO faces competition from established statins like atorvastatin, rosuvastatin, and simvastatin, many of which are available as generics or biosimilars. Its differentiation hinges on tolerability and unique pharmacokinetics, but these advantages are less compelling in a highly commoditized market.

Regulatory and Patent Status

• U.S.: Patents expired in 2019, allowing generic versions.
• Japan and Europe: Patent protections varied, with some extending into 2023-2025.
• Labeling: No recent patent extensions or new indications enhance exclusivity prospects.

What Are the Financial and Commercial Fundamentals?

Revenue Overview

Pivotal to assessing investment viability is LIVALO’s revenue pipeline. Based on 2021 sales data, the drug generated approximately USD 250 million globally. Sales are concentrated in Japan and South Korea, where Broncomb Pharmaceuticals markets LIVALO as its primary lipid-lowering agent.

Profitability & Pricing

• List prices for LIVALO in Japan remain stable at approximately USD 3.50 per pill, but discounts and generic competition have eroded gross margins.
• In markets with generic entry, pricing declines have exceeded 50% within two years of patent expiry.

Manufacturing & Supply Chain

Manufactured by Kowa Co., Ltd., LIVALO benefits from robust supply chain management. However, potential generic entrants could influence supply dynamics and pricing strategies.

R&D and Pipeline Potential

LIVALO’s pipeline is limited, focusing primarily on cardiovascular prevention adjuncts. No recent filings or development initiatives target new indications, reducing future revenue upside.

What Are the Risks and Opportunities?

Risks

• Patent expiration leading to generic erosion.
• Competitive market pressures with no significant differentiation.
• Regulatory changes favoring newer agents or combination therapies.
• Price erosion in key markets decreasing profitability.

Opportunities

• Expanding into emerging markets with rising lipid disorder prevalence.
• Developing combination therapies to improve adherence and outcomes.
• Positioning LIVALO in specific patient populations with tolerability advantages.

What Is the Outlook for Investors?

Given current market and patent dynamics, LIVALO’s revenue potential faces headwinds. It remains relevant in specific markets but offers limited growth outside of emerging regions. Companies with generic rights or biosimilar portfolios could see opportunities in repurposing or expanding use cases, while innovative drug development remains limited.

Key Takeaways

• LIVALO's market share is constrained by patent expiry and generic competition.
• Revenue is concentrated in select Asian markets with high acceptance.
• Pricing pressures are significant, with rapid erosion post-patent expiry.
• Limited pipeline and no new indications restrict future growth.
• Investors should weigh near-term revenues against long-term erosion risks.

FAQs

1. How does LIVALO compare to other statins in efficacy?

LIVALO has demonstrated comparable LDL cholesterol reduction to high-dose atorvastatin, with a potentially better tolerability profile, especially in patients intolerant to other statins.

2. What is LIVALO’s patent status worldwide?

In the U.S., LIVALO’s patents expired in 2019, leading to generic entry. Patent protections in other markets vary, with some expiring between 2023 and 2025.

3. Are there upcoming regulatory changes that could affect LIVALO?

No significant regulatory changes are currently planned that could favor LIVALO explicitly. Evolving guidelines increasingly favor generic utilization and cost-effective therapies.

4. What are the prospects of LIVALO expanding into new indications?

No active development is underway for new indications. Its primary use remains lipid management in hyperlipidemia and cardiovascular risk reduction.

5. Is LIVALO a good candidate for combination therapies?

While not currently developed for combination use, potential exists in co-formulations, particularly with agents targeting hypertension or diabetes, to broaden treatment options.

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Sources:

[1] MarketResearch.com. "Global Hyperlipidemia Drugs Market," 2022.
[2] U.S. Food and Drug Administration. "LIVALO FDA Approval and Patent Information," 2010, 2019.
[3] IQVIA. "Pharmaceutical Market Reports," 2021.
[4] European Medicines Agency. "Drug Approvals and Patent Data," 2022.