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.

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	23
Patent Applications:	1,473
Drug Prices:	Drug price information 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
New England Research Institutes	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

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

Expired US Patents for LIVALO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	5,753,675
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	5,753,675
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	5,854,259
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	6,465,477

International Patents for LIVALO

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

Country	Patent Number	Title	Estimated Expiration
China	101219992	Crystalline forms of pitavastatin calcium
Australia	2004212160	Crystalline forms of pitavastatin calcium
Japan	5702494
China	1747934	Crystalline forms of pitavastatin calcium

Market Dynamics and Financial Trajectory for LIVALO (Pitavastatin Calcium)

Last updated: July 27, 2025

Introduction

LIVALO, marketed as Pitavastatin Calcium, is a lipid-lowering agent classified under statins, primarily used to manage hypercholesterolemia and reduce cardiovascular risk. Since its approval, LIVALO has carved a niche within the competitive statin landscape. Evaluating its market dynamics and financial trajectory requires dissecting regulatory approvals, competitive positioning, pricing strategies, patent landscape, and emerging market opportunities.

Regulatory Approvals and Indications

LIVALO was initially approved in Japan in 2009 and subsequently gained regulatory approval in several markets, including the U.S. (2018), Europe, and Asia. Its primary indication targets hypercholesterolemia, with additional uses in mixed dyslipidemia and cardiovascular risk management. The diversification of indications and regulatory approvals influence its market penetration, especially in markets emphasizing comprehensive cardiovascular risk reduction.

Pharmacological Profile and Competitive Differentiation

Distinct from other statins, LIVALO demonstrates a favorable pharmacokinetic profile characterized by minimal drug-drug interactions, a low potential for adverse effects, and potent LDL cholesterol reduction. Its safety profile and once-daily dosing advantage bolster its perceptions among prescribers. These attributes serve as differentiators, particularly among patients intolerant to other statins.

Market Dynamics

Competitive Landscape

LIVALO operates within a highly competitive milieu dominated by well-established statins such as atorvastatin, rosuvastatin, and simvastatin. Pfizer’s atorvastatin and AstraZeneca’s rosuvastatin (crestor) hold significant market shares, driven by extensive marketing and broad clinical evidence. However, LIVALO’s niche advantages—particularly its favorable tolerance profile—allow it to capture select segments, especially in patients with statin intolerance or specific comorbidities.

Market Penetration and Adoption Trends

Despite its late entry into markets like the U.S., LIVALO has seen steady growth driven by physician preference for a safer statin alternative. In emerging economies, regulatory approvals and local partnerships facilitate market entry. However, prescription volumes remain limited compared to market leaders, owing to entrenched prescribing habits and insurance coverage constraints.

Pricing and Reimbursement Strategies

LIVALO’s pricing varies globally, impacting its market dynamics. In mature markets, reimbursement policies influence uptake; better coverage correlates to increased prescription rates. In markets with high out-of-pocket costs, price sensitivity constrains sales growth. Strategic discounts, co-pay assistance programs, and formulary inclusion foster increased access and utilization.

Patent Lifespan and Generic Entry

As of 2023, LIVALO’s patents are either nearing expiration or have expired in various jurisdictions, opening paths for generic competition. The entry of generics significantly impacts revenue streams, likely causing a decline in per-unit pricing and overall sales volumes unless offset by increased market share or new formulations.

Market Opportunities and Challenges

Emerging markets present growth opportunities due to rising cardiovascular disease prevalence and expanding healthcare infrastructure. Additionally, recent research into LIVALO’s potential benefits in conditions such as diabetic dyslipidemia further broadens its application scope. Conversely, the challenges posed by generic competition, regulatory hurdles, and competing therapies—like PCSK9 inhibitors—temper long-term forecasts.

Financial Trajectory Analysis

Revenue Streams

LIVALO’s revenues depend on prescription volume growth, market penetration, and pricing efficacy. In the U.S., post-approval sales have demonstrated modest growth (Analyst Estimates), with peaks correlating to promotional campaigns and expanded indications. Globally, revenues remain modest compared to top-market statins, but strategic efforts in emerging markets have shown promise.

Profitability and Cost Structure

The drug’s profitability hinges on manufacturing costs, marketing expenses, and licensing agreements. As patent protections wane, profit margins are susceptible to erosion unless cost efficiencies or therapeutic advantages sustain demand. Collaborations with regional partners often help mitigate marketing costs.

Impact of Patent Expirations

Patent expirations generally precipitate erosion of exclusivity-driven revenues. For LIVALO, anticipated patent cliffs in major markets forecast a decline unless repositioned through formulation extensions or new therapeutic indications. The introduction of generic versions in jurisdictions like Europe and Japan can significantly diminish revenue forecasts in the medium term (3-5 years).

Pipeline and Future Development

The development of fixed-dose combinations (FDCs), novel formulations, or new indications—such as its potential role in non-alcoholic fatty liver disease—could provide alternative revenue streams, offsetting losses from generic competition. Additionally, ongoing clinical trials assessing cardiovascular outcomes augment LIVALO’s therapeutic profile, potentially enhancing market value.

Financial Outlook (2023-2028)

Based on current data:

• Short-term (1-2 years): Moderate revenue growth driven by market expansion in Asia and clinical evidence supporting benefits in diverse populations.

• Medium-term (3-5 years): Revenue stabilization or decline in mature markets due to generic competition, unless new indications or formulations gain regulatory approval.

• Long-term (beyond 5 years): Potential revenue resurgence if LIVALO establishes new therapeutic niches or maintains market share through innovation and strategic partnerships.

Strategic Considerations for Stakeholders

• Pharmaceutical Developers: Focus on extending patent life via formulations or indications.
• Investors: Monitor regulatory approvals and market penetration signals, particularly in emerging markets.
• Healthcare Providers: Consider LIVALO’s profile for patients intolerant to other statins, balancing cost and clinical benefit.
• Regulators: Evaluate evidence for expanding indications based on emerging clinical data.

Conclusion

LIVALO’s market dynamics are shaped by competitive intensities, patent expirations, and evolving clinical evidence. While its favorable safety profile and differentiated pharmacology provide a foothold in specific patient segments, the financial trajectory faces headwinds from generic competition and market saturation. Strategic innovation, market expansion, and development of new indications remain critical to securing sustained revenue growth.

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Key Takeaways

• LIVALO benefits from a favorable pharmacological profile but faces stiff competition from established statins.
• Patent expirations will likely lead to revenue declines unless mitigated by new formulations or indications.
• Growth opportunities exist in emerging markets and through expanded therapeutic uses, pending regulatory approvals.
• Cost management and strategic partnerships are vital to maintaining profitability amid generic competition.
• Continuous investment in clinical research and innovation can extend LIVALO’s market relevance.

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FAQs

1. What distinguishes LIVALO from other statins?
LIVALO offers a favorable safety profile, minimal drug-drug interactions, and once-daily dosing, making it suitable for patients intolerant to other statins.

2. How will patent expirations impact LIVALO’s market share?
Patent expirations typically lead to generic entry, which decreases branded sales and revenue unless LIVALO secures new indications or formulations to maintain market relevance.

3. Are there emerging markets where LIVALO could significantly grow?
Yes, Asia-Pacific and Latin America present expanding opportunities due to rising cardiovascular disease prevalence and improving healthcare infrastructure.

4. What role do regulatory agencies play in LIVALO’s market trajectory?
Regulatory approvals for new indications, formulations, or combination therapies can expand LIVALO’s market reach and prolong its revenue life cycle.

5. Can LIVALO capture market share from leading statins?
Potentially, particularly among patients with statin intolerance or specific side effect profiles, provided prescribers recognize its advantages and it remains cost-competitive.

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Sources:

[1] FDA. LIVALO (pitavastatin calcium) prescribing information. 2018.
[2] European Medicines Agency. Summary of product characteristics. 2020.
[3] MarketResearch.com. Global statins market analysis. 2022.
[4] IQVIA. Prescription Trends and Market Data. 2023.
[5] ClinicalTrials.gov. LIVALO clinical trial portfolio. 2023.