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Last Updated: March 27, 2025

STATROL Drug Patent Profile


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Which patents cover Statrol, and when can generic versions of Statrol launch?

Statrol is a drug marketed by Alcon and is included in three NDAs.

The generic ingredient in STATROL is neomycin sulfate; polymyxin b sulfate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the neomycin sulfate; polymyxin b sulfate profile page.

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Summary for STATROL
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 1
DailyMed Link:STATROL at DailyMed
Drug patent expirations by year for STATROL

US Patents and Regulatory Information for STATROL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Alcon STATROL neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050344-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alcon STATROL neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 050456-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alcon STATROL neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OPHTHALMIC 062339-001 Nov 30, 1984 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory of Statins: A Comprehensive Analysis

Introduction to Statins

Statins are a class of drugs widely used for the prevention and treatment of atherosclerosis, a condition that can lead to chest pain, heart attacks, and strokes. These medications are primarily prescribed to lower low-density lipoprotein (LDL) cholesterol in the body, thereby reducing mortality in high-risk patients.

Global Statin Market Overview

The global statin market was valued at US$ 15.39 billion in 2023 and is projected to reach US$ 18.93 billion by 2030, growing at a compound annual growth rate (CAGR) of 3% during the forecast period of 2024-2030[1].

Key Drivers of the Statin Market

Several factors are driving the growth of the statin market:

Increasing Prevalence of Cholesterol-Related Disorders

The rise in cholesterol levels due to changing lifestyles, particularly sedentary lifestyles in developed regions, is a significant driver. Statins are highly recommended when diet and exercise are insufficient to manage bad cholesterol[1].

Cholesterol Awareness Campaigns

Public health campaigns and increased awareness about cholesterol levels have led to higher demand for statins. Technologically advanced healthcare facilities also contribute to this trend[1].

Urbanization and Lifestyle Changes

The rapid pace of urbanization is associated with an increase in cholesterol-related disorders, ensuring sustained demand for statins[1].

Healthcare Guidelines and Recommendations

Guidelines from organizations like the American College of Cardiology and the American Heart Association recommend statins for individuals with a high risk of heart attacks, further boosting demand[1].

Market Segmentation

The statin market is segmented based on drug class, therapeutic treatment, end user, and region.

Drug Class

The market includes various statins such as Atorvastatin, Fluvastatin, Lovastatin, Pravastatin, Simvastatin, and others. Each of these has different efficacy and side effect profiles, catering to a wide range of patient needs[1].

Therapeutic Treatment

Statins are used for treating cardiovascular disorders, obesity, inflammatory disorders, and other conditions. Cardiovascular disorders remain the primary therapeutic area driving the market[1].

End User

Hospitals hold the dominant position in the market due to the increased requirement for treating cardiovascular and inflammatory disorders. Clinics and other healthcare facilities also contribute to the market growth[1].

Regional Market Dynamics

North America

North America held the dominant position in the global statin market in 2023 and is expected to continue its dominance during the forecast period. The high prevalence of cardiovascular diseases, obesity, and diabetes among older populations in this region drives the demand for statins. Over 70% of American adults suffer from LDL cholesterol, making this market particularly lucrative[1].

Other Regions

Indian pharmaceutical companies, such as Ranbaxy Laboratories and Lupin Laboratories, are also making significant strides in the global statin market by marketing generic statins. This expansion is expected to benefit these companies and contribute to market growth[1].

Key Players and Market Strategies

Prominent players in the statin market include Abbott, AstraZeneca, Aurobindo Pharma, Biocon, GlaxoSmithKline, Merck & Co., Novartis, Pfizer, Bayer, and Amgen Inc. These companies are expanding their market presence by establishing strong distribution networks, especially in developing countries. They are also focusing on manufacturing advanced cholesterol-lowering drugs like Evolocumab and Canakinumab to treat high-risk patients[1][4].

Financial Trajectory

Market Size and Growth

The global statin market is expected to grow from US$ 15.39 billion in 2023 to US$ 18.93 billion by 2030, with a CAGR of 3%. This growth is driven by the increasing demand for effective cholesterol-lowering treatments and the expanding patient base due to lifestyle changes and aging populations[1].

Spending on Prescription Drugs

The overall spending on prescription drugs, including statins, is expected to continue growing. Studies indicate that about 60 to 75% of the increase in spending on existing drugs is due to changes in cost per prescription, with the rest attributed to inflation and changes in dosage and supply[3].

Challenges and Restraints

Despite the positive market dynamics, there are several challenges that could hamper the growth of the statin market:

Side Effects and Cultural Factors

Side effects of statins, such as muscle pain and liver damage, can deter some patients from using these medications. Additionally, cultural and commercial factors can influence patient compliance and market growth[1].

Need for Alternative Remedies

The requirement for adequate remedy options other than statins could limit the market growth. Patients and healthcare providers may seek alternative treatments, especially if they are more effective or have fewer side effects[1].

Emerging Opportunities

Advanced Cholesterol-Lowering Drugs

The development and marketing of advanced cholesterol-lowering drugs like Evolocumab and Canakinumab offer significant opportunities for market growth. These drugs are designed to treat high-risk patients more effectively and reduce cardiovascular events[4].

Generic Statins

Indian pharmaceutical companies are focusing on marketing generic statins, which can make these medications more accessible and affordable, thereby expanding the market[1].

Impact of Healthcare Guidelines

Guidelines from reputable health organizations play a crucial role in driving the demand for statins. For instance, the American College of Cardiology and the American Heart Association's guidelines recommending statins for individuals with a high risk of heart attacks have significantly increased statin usage in the US and Canada[1].

"Guidelines from organizations like the American College of Cardiology and the American Heart Association recommend statins for individuals with a high risk of heart attacks, further boosting demand"[1].

Conclusion

The statin market is poised for steady growth driven by increasing cholesterol-related disorders, advanced healthcare facilities, and strong guidelines from health organizations. Despite challenges such as side effects and the need for alternative remedies, the market is expected to benefit from the development of advanced cholesterol-lowering drugs and the expansion of generic statins.

Key Takeaways

  • The global statin market is projected to grow from US$ 15.39 billion in 2023 to US$ 18.93 billion by 2030.
  • North America dominates the market due to high prevalence of cardiovascular diseases.
  • Key players are expanding their market presence through strong distribution networks and advanced drug manufacturing.
  • Side effects and the need for alternative remedies are potential restraints.
  • Emerging opportunities include advanced cholesterol-lowering drugs and generic statins.

FAQs

What is the expected growth rate of the global statin market from 2024 to 2030?

The global statin market is growing at a CAGR of 3% during the forecast period of 2024-2030[1].

Which region holds the largest share in the global statin market?

North America holds the highest share in the global statin market[1].

What are the primary therapeutic areas for statin use?

Statins are primarily used for treating cardiovascular disorders, obesity, and inflammatory disorders[1].

Who are the key players in the global statin market?

Key players include Abbott, AstraZeneca, Aurobindo Pharma, Biocon, GlaxoSmithKline, Merck & Co., Novartis, Pfizer, Bayer, and Amgen Inc.[1].

What are the main challenges facing the statin market?

The main challenges include side effects of statins, cultural and commercial factors, and the need for alternative remedy options[1].

Sources

  1. Maximize Market Research: Statin Market: Global Industry Analysis and Forecast (2024-2030)
  2. PubMed: Association between trajectories of statin adherence and subsequent cardiovascular events.
  3. ASPE: Explaining the Growth in Prescription Drug Spending: A Review of Recent Studies
  4. Zion Market Research: Cholesterol-Lowering Drug Market Size, Share, Analysis, Forecasts 2023-2030

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