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Last Updated: December 22, 2024

PITAVASTATIN MAGNESIUM - Generic Drug Details


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What are the generic sources for pitavastatin magnesium and what is the scope of patent protection?

Pitavastatin magnesium is the generic ingredient in one branded drug marketed by Medicure and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Pitavastatin magnesium has two patent family members in two countries.

There is one drug master file entry for pitavastatin magnesium. Two suppliers are listed for this compound.

Summary for PITAVASTATIN MAGNESIUM
International Patents:2
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 3
Patent Applications: 16
What excipients (inactive ingredients) are in PITAVASTATIN MAGNESIUM?PITAVASTATIN MAGNESIUM excipients list
DailyMed Link:PITAVASTATIN MAGNESIUM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PITAVASTATIN MAGNESIUM
Generic Entry Date for PITAVASTATIN MAGNESIUM*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for PITAVASTATIN MAGNESIUM
Anatomical Therapeutic Chemical (ATC) Classes for PITAVASTATIN MAGNESIUM

US Patents and Regulatory Information for PITAVASTATIN MAGNESIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicure ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379-001 Jul 14, 2017 DISCN Yes No 8,829,186 ⤷  Subscribe Y Y ⤷  Subscribe
Medicure ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379-003 Jul 14, 2017 RX Yes Yes 8,829,186 ⤷  Subscribe Y Y ⤷  Subscribe
Medicure ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379-002 Jul 14, 2017 RX Yes No 8,829,186 ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PITAVASTATIN MAGNESIUM Market Analysis and Financial Projection Experimental

Pitavastatin Magnesium: Market Dynamics and Financial Trajectory

Market Overview

The global pitavastatin market is poised for significant growth, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of pitavastatin magnesium.

Market Size and Growth

As of 2023, the global pitavastatin market was valued at approximately USD 537.1 million and is projected to reach USD 890.2 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.7% during the forecast period[1][3][5].

Key Drivers of Growth

Increasing Prevalence of Cardiovascular Diseases

The escalating incidence of cardiovascular diseases, particularly hyperlipidemia, is a primary driver for the pitavastatin market. Hyperlipidemia, characterized by elevated levels of lipids such as cholesterol and triglycerides, is a significant risk factor for heart attacks and strokes, thereby increasing the demand for effective lipid-lowering medications like pitavastatin[1][3][4].

Technological Advancements in Drug Formulations

Ongoing research and development have led to advancements in pitavastatin formulations, enhancing its efficacy and patient compliance. Improved drug delivery systems contribute significantly to market growth, making pitavastatin a preferred choice for managing cholesterol levels[1][3][4].

Growing Aging Population

The demographic shift toward an aging population contributes to a higher prevalence of cardiovascular conditions, driving the demand for medications like pitavastatin. As the population ages, the need for preventive and therapeutic measures to manage cardiovascular risk factors increases[3].

Preventive Healthcare Emphasis

Increasing awareness of preventive healthcare measures and the importance of managing cardiovascular risk factors propels the demand for pitavastatin as a preventive medication. This emphasis on preventive care is supported by government initiatives and public health campaigns, further boosting the market[1][3].

Digital Health Integration

The integration of pitavastatin prescriptions with digital health solutions enhances patient adherence through reminders, monitoring, and telehealth consultations. This trend is particularly notable in the Asia-Pacific region, where the swift uptake of digital technologies has improved patient accessibility and compliance[1][3].

Market Segmentation

By Type

Pitavastatin is available in various dosages, including 1 mg, 2 mg, and 4 mg. Each dosage has its specific efficacy and patient profile, with the 2 mg and 4 mg doses being particularly effective in reducing LDL-C levels and achieving EAS and NCEP targets[3][4].

By Application

Pitavastatin finds widespread application in managing hyperlipidemia and is often used in combination therapies to target various cardiovascular risk factors. Its effectiveness in lowering cholesterol levels and targeting specific lipid irregularities makes it a vital component of holistic cardiovascular care[1][3][4].

By End-user

The hospital segment has witnessed significant growth, with healthcare providers increasingly recommending pitavastatin alongside other cardiovascular medications. This trend is particularly pronounced in North America, where combination therapies are becoming more common[1].

By Region

North America is expected to register the highest market share, driven by a strong healthcare infrastructure and high awareness of cardiovascular health. The Asia-Pacific region is also projected to grow rapidly, driven by the integration of digital health solutions and increasing healthcare needs[1][3].

Financial Incentives and Adherence

Financial incentives can play a crucial role in improving medication adherence. Studies have shown that different financial incentives can enhance statin adherence, although they may not directly impact LDL-C levels. This highlights the importance of directly measuring health outcomes rather than just adherence[2].

Recent Developments and Trends

Combination Therapies and Personalized Medicine

There is an increasing focus on combination therapies and personalized medicine approaches involving pitavastatin. This trend allows for more targeted and effective cardiovascular care, addressing specific patient profiles and providing comprehensive treatment strategies[1][3].

Mergers and Acquisitions

The pitavastatin market has seen several mergers and acquisitions, with companies seeking to expand their market presence and leverage synergies to improve their product offerings and profitability. These strategic moves help companies gain a competitive edge in the market[3].

Government Initiatives

Supportive government initiatives aimed at promoting cardiovascular health and preventive care contribute to the pitavastatin market. Policies focusing on disease awareness, early detection, and affordable access to medications enhance market growth by addressing population health on a broader scale[3].

Challenges and Threats

Regulatory Challenges

Evolving regulatory standards and challenges associated with obtaining approvals for new formulations or indications can present obstacles, potentially delaying market entry or expansion for pitavastatin. Changes in healthcare policies and reimbursement structures can also impact the affordability and accessibility of the drug[1].

Generic Alternatives

The emergence of generic alternatives poses a risk to branded pitavastatin, potentially leading to price erosion and a reduction in market share. This competition can impact the profitability of branded pitavastatin and necessitate strategic pricing and marketing strategies[1][3].

Alternative Therapies

The development and adoption of alternative therapies for managing hyperlipidemia and cardiovascular risk factors could divert market share from pitavastatin, posing a threat to its dominance in the market. Continuous innovation and R&D are crucial to maintaining market share[3].

Clinical Efficacy

Pitavastatin has demonstrated significant clinical efficacy in managing primary hypercholesterolemia and combined dyslipidemia. Studies have shown that pitavastatin is non-inferior to other statins like simvastatin and atorvastatin in reducing LDL-C levels and achieving EAS and NCEP targets. Long-term treatment with pitavastatin also maintains the reduction in LDL-C levels and increases HDL-C levels over time[4].

Plaque Regression

Pitavastatin has been shown to induce plaque regression through changes in lipid profiles and pleiotropic effects. Studies using intravascular ultrasound have demonstrated that pitavastatin reduces the volumes of nonculprit plaques, associated with negative vessel remodeling[4].

Key Players

Key players in the pitavastatin market, such as Pfizer, Novartis, and AstraZeneca, maintain their stronghold through continuous innovation, extensive R&D investments, and strategic collaborations. These companies leverage their established brand recognition, global distribution networks, and commitment to cardiovascular health to navigate market dynamics and sustain growth[3].

Regional Insights

North America

North America is expected to register the highest market share, driven by a strong emphasis on combination therapies and a well-developed healthcare infrastructure. Healthcare providers in this region are increasingly investigating and recommending pitavastatin alongside other cardiovascular medications[1].

Asia-Pacific

The Asia-Pacific region is projected to grow rapidly, driven by the integration of digital health solutions and increasing healthcare needs. The swift uptake of digital technologies has led to improved patient accessibility, adherence, and monitoring of pitavastatin prescriptions in this region[1][3].

Key Takeaways

  • Market Growth: The global pitavastatin market is expected to grow from USD 537.1 million in 2023 to USD 890.2 million by 2031 at a CAGR of 6.7%.
  • Key Drivers: Increasing prevalence of cardiovascular diseases, technological advancements, growing aging population, and preventive healthcare emphasis.
  • Market Segmentation: Segmented by type, application, end-user, and region, with North America and Asia-Pacific being key regions.
  • Clinical Efficacy: Pitavastatin is clinically efficacious in managing hyperlipidemia and reducing LDL-C levels, with long-term benefits in plaque regression and HDL-C increase.
  • Challenges: Regulatory challenges, generic alternatives, and alternative therapies pose threats to market dominance.

FAQs

Q: What is the projected market size of pitavastatin by 2031?

The global pitavastatin market is projected to reach USD 890.2 million by 2031[1].

Q: What are the primary drivers of the pitavastatin market?

The primary drivers include the increasing prevalence of cardiovascular diseases, technological advancements in drug formulations, a growing aging population, and an emphasis on preventive healthcare[1][3].

Q: How does pitavastatin compare to other statins in clinical efficacy?

Pitavastatin is non-inferior to other statins like simvastatin and atorvastatin in reducing LDL-C levels and achieving EAS and NCEP targets. It also maintains long-term benefits in plaque regression and HDL-C increase[4].

Q: What role do financial incentives play in pitavastatin adherence?

Financial incentives can improve medication adherence, although they may not directly impact LDL-C levels. This highlights the importance of directly measuring health outcomes rather than just adherence[2].

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

North America and the Asia-Pacific region are expected to drive the growth of the pitavastatin market, with North America registering the highest market share and the Asia-Pacific region growing rapidly due to digital health integration[1][3].

Sources

  1. InsightAce Analytic: Pitavastatin Market Current Scenario Analysis Report 2024-2031.
  2. PubMed: Effect of Patient Financial Incentives on Statin Adherence and Lipid Levels.
  3. Custom Market Insights: Global Pitavastatin Market Size, Trends, Share 2032.
  4. NATAP: Pitavastatin: a distinctive lipid-lowering drug.
  5. Custom Market Insights: Global Pitavastatin Market Size Reach $910.6 Million 2032.

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