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Last Updated: December 23, 2024

ROSUVASTATIN Drug Patent Profile


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When do Rosuvastatin patents expire, and what generic alternatives are available?

Rosuvastatin is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Biocon Pharma, Cadila Pharms Ltd, Changzhou Pharm, Chartwell Rx, Glenmark Speclt, Hetero Labs Ltd V, Inventia, Lupin, Macleods Pharms Ltd, MSN, Renata, Sandoz, Sciegen Pharms Inc, Shandong, Strides Pharma, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Watson Labs Inc, Zhejiang Jingxin, and Zhejiang Yongtai. and is included in twenty-eight NDAs.

The generic ingredient in ROSUVASTATIN is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rosuvastatin

A generic version of ROSUVASTATIN was approved as rosuvastatin calcium by WATSON LABS INC on April 29th, 2016.

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Drug patent expirations by year for ROSUVASTATIN
Drug Prices for ROSUVASTATIN

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Drug Sales Revenue Trends for ROSUVASTATIN

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US Patents and Regulatory Information for ROSUVASTATIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 206381-004 Apr 24, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs Inc ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 079167-001 Apr 29, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V ROSUVASTATIN CALCIUM rosuvastatin calcium TABLET;ORAL 207616-001 Oct 31, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ROSUVASTATIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rosuvastatin

Introduction to Rosuvastatin

Rosuvastatin, a potent statin, is widely used to treat high cholesterol and prevent cardiovascular diseases. It is known for its effectiveness in reducing low-density lipoprotein (LDL) cholesterol, a primary risk factor for heart disease.

Market Size and Growth

The rosuvastatin market is experiencing significant growth driven by several key factors. As of 2022, the market size was valued at USD 463.85 million, and it is projected to reach USD 655.99 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.0% during the forecast period (2023-2031)[1].

Another analysis suggests a slightly higher market valuation, with the rosuvastatin market size estimated at USD 6.4 billion in 2023 and projected to reach USD 22.9 billion by 2031, growing at a CAGR of 4.7% from 2024-2031[3].

Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The escalating incidence of cardiovascular diseases (CVD) is a major driver for the rosuvastatin market. Factors such as unhealthy lifestyles, poor dietary habits, smoking, and lack of physical activity have contributed to a steep increase in CVD globally. Rosuvastatin's effectiveness in reducing LDL cholesterol makes it a critical treatment option, thereby driving demand[3].

Aging Population

The growing aging population is another significant driver. As individuals age, the risk of developing chronic diseases, including CVD, increases. Elderly populations often have elevated cholesterol levels due to age-related metabolic changes, making them prime candidates for statin therapy like rosuvastatin[3].

Government Initiatives and Healthcare Investments

Increasing allocations of funds by governments to the healthcare industry are expected to open new opportunities for the rosuvastatin market. For instance, the Indian government allocated USD 10.76 billion to the Ministry of Health and Family Welfare in the Union Budget 2023-24, and plans to introduce a credit incentive program worth USD 6.8 billion to boost healthcare infrastructure[1].

Research and Development Investments

Growing investments in pharmaceutical and biotechnology research and development activities are driving the demand for rosuvastatin. Health industries invested USD 199.24 billion in R&D in 2020, which accounted for 20.8% of total business R&D expenditure worldwide[1].

Regional Market Analysis

North America

North America accounted for the highest market share in 2022, with 35.15% of the global market valued at USD 163.04 million. The U.S. dominated this region with a 66.15% market share. The well-established healthcare infrastructure and high incidence of cardiovascular diseases in North America drive the demand for rosuvastatin in this region[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth, with a CAGR of 4.4% during the forecast period. The high population, large patient pool, and developing medical infrastructure in this region contribute to this growth. Initiatives by governments and healthcare agencies to reduce the burden of CVD also support market expansion in this region[1].

Distribution Channels

Online Pharmacies

The online pharmacies segment is expected to hold the highest CAGR over the forecast period. The increasing sale of pharmaceutical products through e-commerce platforms is providing lucrative growth opportunities. For example, the Indian e-pharmacy market is predicted to increase at a compounded annual rate of 44% to USD 4.5 billion by 2025[1].

Competitive Landscape

The rosuvastatin market is highly competitive, with several large players and numerous small and medium-sized enterprises. Companies focus on expanding their product offerings and increasing their market share through mergers, acquisitions, and partnerships. Key players have strong research and development capabilities and extensive product portfolios and distribution networks[1].

Pricing and Affordability

Out-of-Pocket Costs

The out-of-pocket cost for rosuvastatin in the U.S. has seen fluctuations. In 2014, the average out-of-pocket cost was almost USD 63, but it decreased to between USD 9 and USD 10 from 2019 to 2021. However, it increased to USD 12.57 in 2022[2].

Impact of Generic Versions

The introduction of generic rosuvastatin has significantly reduced costs and increased accessibility. Generic statins have captured a substantial market share, leading to a decrease in overall spending on statins. For instance, in the U.S. Medicaid population, generic statins quickly captured the market after 2006, reducing expenditures on brand-name statins[4].

Formulation Innovations

Advances in drug formulations and delivery methods are expected to enhance patient adherence and expand market opportunities. Innovations in formulations can make rosuvastatin more effective and easier to use, which can further drive market growth[3].

Regulatory Approvals

New approvals and patent extensions for rosuvastatin contribute to its market presence and growth. These regulatory developments ensure that the drug remains a viable treatment option and can be adapted to new patient needs[3].

Health Campaigns and Awareness

Increased awareness and health campaigns aimed at reducing cardiovascular diseases also drive the demand for rosuvastatin. For example, the World Health Organization's initiatives to reduce mortality from CVD, such as the SEA HEARTS initiative, highlight the importance of effective treatments like rosuvastatin[1].

Key Takeaways

  • The rosuvastatin market is projected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and the aging population.
  • North America currently holds the highest market share, but the Asia Pacific region is expected to witness significant growth.
  • Online pharmacies are emerging as a key distribution channel.
  • The introduction of generic versions has increased affordability and accessibility.
  • Regulatory approvals and formulation innovations are crucial for market expansion.

FAQs

What is the current market size of rosuvastatin, and what is its projected growth?

The rosuvastatin market size was valued at USD 463.85 million in 2022 and is projected to reach USD 655.99 million by 2031, growing at a CAGR of 4.0% during the forecast period[1].

What are the primary drivers of the rosuvastatin market?

The primary drivers include the increasing prevalence of cardiovascular diseases, the growing aging population, and increasing investments in healthcare and R&D[1][3].

Which region holds the highest market share for rosuvastatin?

North America holds the highest market share, with the U.S. accounting for 66.15% of the regional market in 2022[1].

How has the introduction of generic rosuvastatin impacted the market?

The introduction of generic rosuvastatin has significantly reduced costs, increased accessibility, and captured a substantial market share, leading to a decrease in overall spending on brand-name statins[4].

What role do online pharmacies play in the rosuvastatin market?

Online pharmacies are expected to hold the highest CAGR over the forecast period due to the increasing sale of pharmaceutical products through e-commerce platforms[1].

Sources

  1. Consegic Business Intelligence: "Rosuvastatin Market Size, Share| Trends Analysis 2031"
  2. Statista: "Rosuvastatin out-of-pocket cost U.S. 2004-2022"
  3. Verified Market Research: "Rosuvastatin Market Size, Scope, Trends, Analysis & Forecast"
  4. AHDB Online: "A Retrospective Trend Analysis of Utilization, Spending, and Prices for Generic Statins in the US Medicaid Population 1991-2022"

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