PITAVASTATIN CALCIUM - Generic Drug Details

What are the generic sources for pitavastatin calcium and what is the scope of freedom to operate?

Pitavastatin calcium is the generic ingredient in two branded drugs marketed by Kowa Co, Amneal Pharms Ny, Aurobindo Pharma, Hetero Labs Ltd V, Lupin Ltd, Mylan, Orient Pharma Co Ltd, Sawai Usa, and Zydus Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for pitavastatin calcium. Thirteen suppliers are listed for this compound.

Summary for PITAVASTATIN CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	3
Patent Applications:	2,886
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PITAVASTATIN CALCIUM
What excipients (inactive ingredients) are in PITAVASTATIN CALCIUM?	PITAVASTATIN CALCIUM excipients list
DailyMed Link:	PITAVASTATIN CALCIUM at DailyMed

Recent Clinical Trials for PITAVASTATIN CALCIUM

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

Sponsor	Phase
C.Dirven	EARLY_PHASE1
Jun Tao	Phase 4
Sun Yat-sen University	Phase 4

See all PITAVASTATIN CALCIUM clinical trials

Pharmacology for PITAVASTATIN CALCIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for PITAVASTATIN CALCIUM

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for PITAVASTATIN CALCIUM

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 PITAVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205961-001	Aug 20, 2024	AB	RX	No	No
Hetero Labs Ltd V	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205977-003	Apr 30, 2024	AB	RX	No	No
Orient Pharma Co Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205932-003	Feb 3, 2017	AB	RX	No	No

Expired US Patents for PITAVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	5,854,259
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009	6,465,477
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	5,753,675

Market Dynamics and Financial Trajectory for Pitavastatin Calcium

Last updated: July 27, 2025

Introduction

Pitavastatin Calcium, marketed under names such as Livalo and Xatral, is a statin-class medication primarily prescribed for managing hypercholesterolemia and preventing cardiovascular disease. As a potent lipid-lowering agent, Pitavastatin’s unique pharmacological profile has positioned it as a competitive drug within the global statin market. This analysis explores market dynamics influencing Pitavastatin Calcium's commercial trajectory, including competitive landscape, regulatory environment, patent scenarios, and emerging opportunities, along with projections for future financial performance.

Market Overview and Key Drivers

Global Market Segmentation

The global hyperlipidemia therapeutics market, estimated to be valued at over USD 21 billion in 2022, comprises various statins, including Atorvastatin, Rosuvastatin, Simvastatin, and Pitavastatin. Among these, Pitavastatin's market share remains modest but growing due to its differentiated efficacy and safety profile.

Factors Influencing Market Growth

• Prevalence of Cardiovascular Disease: The rising incidence of heart disease, stroke, and associated metabolic disorders globally fuels demand for effective lipid management. The World Health Organization estimates over 17 million cardiovascular-related deaths annually, underscoring therapeutic needs[1].

• Clinician Preference for Lipid-Lowering Agents: Increasing emphasis on personalized medicine and tolerability favors drugs like Pitavastatin, which reports fewer adverse effects compared to some other statins (e.g., less drug-drug interaction and lower risk of diabetes onset).

• Regulatory Approvals and Expanded Indications: Recent approvals and label extensions have broadened Pitavastatin's use, enhancing its market appeal.

• Generics and Patent Expirations: While initially protected by patents, patent cliffs for key competitors have shifted focus towards newer entrants like Pitavastatin, which benefits from later patent filings and regulatory exclusivity.

Competitive Landscape

Market Positioning of Pitavastatin Calcium

Compared to long-established statins such as Atorvastatin (Lipitor) and Rosuvastatin (Crestor), Pitavastatin is relatively newer, with regulatory approval in select regions. Its differentiated profile—marked by minimal CYP450 metabolism, reduced myopathy risk, and favorable pharmacokinetics—makes it appealing, especially for patients intolerant to other statins.

Manufacturers and Market Share

Key players producing Pitavastatin include Kowa Company (Japan), which developed the drug, and generic manufacturers targeting cost-sensitive markets. While overall market penetration remains limited compared to dominant statins, increasing generic adoption will likely boost accessible supply and stimulate volume sales.

Pricing and Reimbursement

Pricing strategies are influenced by regional healthcare policies. In high-income markets, patents and premium pricing secure profitability, whereas in emerging economies, generics and price competition mandate more aggressive pricing, affecting gross margins.

Regulatory and Patent Landscape

Regulatory Approvals and Off-Label Uses

Pitavastatin’s approval status varies worldwide; it is approved by the U.S. FDA in 2009 primarily for hypercholesterolemia, with potential off-label benefits under investigation. Regulatory hurdles in some markets remain, but ongoing clinical trials may facilitate broader acceptance.

Patent Exclusivity and Share Trends

Kowa secured patent protections in key markets. Upcoming expirations for competitors' patents and local patent filings for formulations and uses provide opportunities for commercialization. However, patent challenges and patent cliffs can impact future revenue projections significantly.

Emerging Opportunities and Challenges

Clinical Evidence and New Indications

Recent studies highlight Pitavastatin’s potential in reducing arterial stiffness, improving insulin sensitivity, and even adjunct roles in COVID-19 management due to anti-inflammatory properties. Such evidence can support label extensions and expanded market adoption.

Market Challenges

• Limited Awareness and Prescriber Familiarity: As newer agents, Pitavastatin’s clinician adoption is hindered by limited clinical familiarity relative to legacy statins.

• Competitive Intensity: The dominance of established statins with extensive generic infrastructure exerts downward pressure on pricing and market share.

• Regional Regulatory Disparities: Delayed approvals or restricted use in certain regions impede growth.

Financial Trajectory and Forecasting

Revenue Projections

Based on current market trends, the Pitavastatin Calcium market is poised for moderate growth over the coming five years, compounded by increasing prevalence of cardiovascular diseases and expanded clinical usage. Industry analysts project a CAGR of approximately 4-6%, pushing revenues toward USD 1.2–1.5 billion globally by 2028[2].

Impact of Patent Expiries

Patent expirations in developed markets could lead to significant market share erosion for branded formulations, spurring a shift toward generics. This transition is expected to compress margins but increase volume sales, with revenues potentially stabilizing or slightly declining in mature markets.

Pricing Strategies and Market Penetration

Emerging markets will likely see increased penetration through generic formulations, driven by cost-sensitive healthcare systems. Strategic alliances, local manufacturing, and regulatory navigation are critical to capitalize on these regions.

R&D Investment and Future Growth

Investment in clinical trials evaluating additional indications—such as cardiometabolic or neuroprotective uses—can enhance long-term revenue streams. Collaborations with biotech firms and licensing agreements may further diversify revenue sources.

Conclusion

Market dynamics for Pitavastatin Calcium present a landscape of steady growth tempered by competitive and regulatory challenges. Its favorable safety profile and potential for broader clinical applications offer avenues for expansion, especially in underserved markets. Efficient management of patent strategies, clinical research investments, and regional regulatory navigation will be paramount to realize its full financial potential.

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Key Takeaways

• Growing Cardiovascular Disease Burden: The rise in cardiovascular cases globally sustains demand for effective lipid-lowering therapies like Pitavastatin.

• Market Differentiation: Its tolerability and unique pharmacokinetics position Pitavastatin favorably among statins, offering advantages in personalized medicine.

• Patent and Regulatory Strategy: Protecting exclusivity and expediting approvals are essential to maintaining market share and maximizing revenue.

• Emerging Indications: New clinical evidence supporting additional uses can unlock untapped revenue streams and increase drug utilization.

• Market Expansion in Emerging Economies: Cost-effective generics and strategic partnerships facilitate growth in low- and middle-income countries.

FAQs

1. What are the primary advantages of Pitavastatin Calcium over other statins?
   Pitavastatin demonstrates lower drug-drug interaction potential, fewer reports of myopathy, and a favorable safety profile, making it well-suited for patients with statin intolerance.

2. In which regions is Pitavastatin most commercially successful?
   Currently, Japan and certain Asian markets dominate its sales, with expanding presence in Europe and the U.S. following regulatory approval and clinical advocacy.

3. How do patent expirations affect Pitavastatin’s market trajectory?
   Patent expirations in major markets open opportunities for generic manufacturers, leading to price reductions but also increased volume sales, which can stabilize overall revenues.

4. Are there ongoing clinical trials for new indications involving Pitavastatin?
   Yes. Emerging evidence suggests potential benefits in metabolic syndromes, arterial stiffness, and inflammatory conditions, prompting ongoing and future clinical trials.

5. What challenges could hinder Pitavastatin’s market growth?
   Limited prescriber awareness, strong competition from established statins, regulatory delays in certain markets, and pricing pressures from generics pose significant hurdles.

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References

[1] World Health Organization. Cardiovascular Diseases Fact Sheet. 2022.
[2] Market Research Future. Global Statins Market Report. 2022.