Pitavastatin calcium - Generic Drug Details

What are the generic drug 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. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pitavastatin calcium has fifty-three patent family members in seventeen countries.

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

Summary for pitavastatin calcium

International Patents:	53
US Patents:	2
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	2
Patent Applications:	7,177
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
Jun Tao	Phase 4
Sun Yat-sen University	Phase 4
Chonnam National University Hospital	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
Hetero Labs Ltd V	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205977-003	Apr 30, 2024	AB	RX	No	No
Hetero Labs Ltd V	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	205977-002	Apr 30, 2024	AB	RX	No	No
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-002	Aug 3, 2009	AB	RX	Yes	No					Y
Mylan	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206070-003	Apr 4, 2019	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	022363-003	Aug 3, 2009
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 pitavastatin calcium

Country	Patent Number	Title	Estimated Expiration
South Korea	101376449
Japan	5474276
Cyprus	1110133
Japan	2007523049

Pitavastatin calcium Market Analysis and Financial Projection Experimental

Pitavastatin Calcium: Market Dynamics and Financial Trajectory

Introduction

Pitavastatin calcium, a potent statin, has been gaining significant traction in the pharmaceutical and healthcare sectors due to its efficacy in managing hyperlipidemia and reducing the risk of cardiovascular diseases. Here, we delve into the market dynamics and financial trajectory of pitavastatin calcium, highlighting key factors driving its growth and future prospects.

Market Size and Projection

The pitavastatin calcium market has been experiencing robust growth. As of 2023, the market size was valued at USD 537.1 million and is predicted to reach USD 890.2 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period of 2024-2031[3].

Key Drivers of Market Growth

Increased Adoption of Combination Therapies

Healthcare providers are increasingly recommending pitavastatin alongside other cardiovascular medications to target various risk factors, adopting a more holistic approach to managing patients with hyperlipidemia. This trend is particularly noticeable in North America, where combination therapies are becoming more prevalent[3].

Technological Innovations in Drug Delivery

Advancements in drug delivery systems and formulations are enhancing the therapeutic benefits of pitavastatin. Strategic partnerships and collaborations between pharmaceutical companies and research institutions are driving these innovations, leading to the development of novel pitavastatin-based products[1].

Regulatory Developments

Recent approvals and updates in treatment guidelines are expanding the indications for pitavastatin, allowing it to be used in a broader range of clinical scenarios. These regulatory changes are driving demand and market growth by providing new opportunities for its use[1].

Rising Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases due to lifestyle factors and aging populations is a significant driver for the pitavastatin market. As cardiovascular conditions become more common, the demand for effective cholesterol-lowering medications like pitavastatin is on the rise[1].

Growing Awareness and Demand for Preventive Care

There is a growing awareness and demand for preventive healthcare measures, particularly in managing cardiovascular risk factors. This shift towards preventive care is fueling the demand for pitavastatin as a preventive medication[3].

Economic Value and Cost-Effectiveness

Pitavastatin calcium offers substantial economic value due to its competitive pricing compared to other statins. Its ability to provide cost-effective long-term management of cholesterol-related conditions makes it an attractive option for both patients and healthcare systems. This cost-effectiveness presents significant opportunities for investment and business development in the pharmaceutical industry[1].

Geographical Market Dynamics

North America

The North America pitavastatin market is expected to register the highest market share. The region is seeing a noticeable shift towards combination therapies, with healthcare providers integrating pitavastatin into comprehensive treatment plans for hyperlipidemia[3].

Asia Pacific

The Asia Pacific region is projected to grow at a rapid rate in the global pitavastatin market. The swift uptake of digital health solutions, such as telehealth services, mobile apps, and online platforms, is improving patient accessibility, adherence, and monitoring of pitavastatin prescriptions in this region[3].

Clinical Efficacy and Safety Profile

Lipid Lowering Effects

Pitavastatin has been shown to be highly effective in reducing LDL cholesterol levels by 38% to 44% and triglycerides by 14% to 22%, while increasing HDL cholesterol levels by 5% to 8%. These effects are comparable to those of other statins like atorvastatin and simvastatin at low to intermediate doses[2][5].

Safety Profile

The safety profile of pitavastatin is favorable, with adverse events including gastrointestinal symptoms, myopathies, and elevated hepatic enzyme concentrations. The incidence of severe muscle toxicity, such as rhabdomyolysis, is minimal at doses of 4 mg or less[2][5].

Investment in R&D and Strategic Partnerships

Ongoing Research and Development

Pharmaceutical companies are investing heavily in research and development to explore new formulations, delivery systems, and therapeutic uses for pitavastatin. This investment is driving innovation and contributing to the drug’s market expansion and success[1].

Strategic Partnerships

Strategic partnerships and collaborations between pharmaceutical companies and research institutions are crucial for the growth of the pitavastatin market. These partnerships focus on expanding research into new therapeutic uses and improving drug formulations, leading to the development of novel pitavastatin-based products and innovative treatment solutions[1].

Key Players in the Market

The pitavastatin calcium market involves several key players, including NISSAN CHEMICAL CORP, MSN LABORATORIES PRIVATE LTD, SOLARA ACTIVE PHARMA SCIENCES LTD, AUROBINDO PHARMA LTD, MYLAN LABORATORIES LTD, and others. These companies are actively involved in the production, distribution, and research of pitavastatin calcium[4].

Future Prospects

Market Expansion

The future of pitavastatin looks promising, with ongoing research and developments poised to enhance its impact on cardiovascular health. The market is expected to expand as new indications, combination therapies, and improved formulations become available[1].

Digital Health Integration

The integration of digital health solutions is expected to continue, improving patient care and adherence to pitavastatin prescriptions. This trend will be particularly significant in regions like the Asia Pacific, where digital health is rapidly advancing[3].

Key Takeaways

• The pitavastatin calcium market is growing significantly due to its efficacy in managing hyperlipidemia and reducing cardiovascular disease risk.
• Combination therapies, technological innovations, and regulatory developments are key drivers of market growth.
• The market is expected to reach USD 890.2 million by 2031, growing at a CAGR of 6.7%.
• North America and the Asia Pacific are key regions driving market growth.
• Ongoing research and strategic partnerships are crucial for the market’s expansion.

FAQs

What is the primary use of pitavastatin calcium?

Pitavastatin calcium is primarily used to manage hyperlipidemia and reduce the risk of cardiovascular diseases by lowering LDL cholesterol levels.

How effective is pitavastatin calcium in reducing LDL cholesterol?

Pitavastatin calcium reduces LDL cholesterol levels by 38% to 44%, which is comparable to other statins like atorvastatin and simvastatin at low to intermediate doses[2].

What are the key drivers of the pitavastatin calcium market growth?

Key drivers include the increased adoption of combination therapies, technological innovations in drug delivery, regulatory developments, rising prevalence of cardiovascular diseases, and growing awareness and demand for preventive care[1][3].

Which regions are expected to drive the growth of the pitavastatin calcium market?

North America and the Asia Pacific are expected to be the key regions driving market growth, with North America registering the highest market share and the Asia Pacific growing at a rapid rate[3].

What is the safety profile of pitavastatin calcium?

The safety profile of pitavastatin calcium is favorable, with adverse events including gastrointestinal symptoms, myopathies, and elevated hepatic enzyme concentrations. Severe muscle toxicity is minimal at doses of 4 mg or less[2][5].

Sources

1. Market Research Intellect: "Pitavastatin Calcium Market Soars: Key Factors Driving Growth in Pharma and Healthcare"
2. PubMed: "Pitavastatin calcium: clinical review of a new antihyperlipidemic agent"
3. InsightAce Analytic: "Pitavastatin Market Current Scenario Analysis Report 2024-2031"
4. Valuates Reports: "Pharmaceutical Grade Pitavastatin Calcium - Market Size"
5. FDA: "Livalo (Pitavastatin) Tablets Drug Review Package"