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Last Updated: December 22, 2024

BARSTATIN 100 Drug Patent Profile


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Which patents cover Barstatin 100, and what generic alternatives are available?

Barstatin 100 is a drug marketed by Barlan and is included in one NDA.

The generic ingredient in BARSTATIN 100 is nystatin. There are eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the nystatin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Barstatin 100

A generic version of BARSTATIN 100 was approved as nystatin by FOUGERA PHARMS on September 23rd, 1982.

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Summary for BARSTATIN 100
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 21
DailyMed Link:BARSTATIN 100 at DailyMed
Drug patent expirations by year for BARSTATIN 100

US Patents and Regulatory Information for BARSTATIN 100

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barlan BARSTATIN 100 nystatin POWDER;ORAL 062489-001 Apr 27, 1988 DISCN 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

BARSTATIN 100 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Statin Drugs: A Case Study of BARSTATIN 100

Introduction

Statin drugs, including hypothetical products like BARSTATIN 100, are a cornerstone in the management of hypercholesterolemia and the prevention of cardiovascular events. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare policymakers.

Market Size and Growth

The statin market is substantial and has been growing over the years. In 2014, global sales of statins reached approximately $28.5 billion[4].

  • This market size is driven by the increasing incidence of hypercholesterolemia and the expanding use of statins in primary and secondary prevention of cardiovascular diseases.

Key Players and Market Competition

The statin market is highly competitive, with multiple players including both branded and generic drugs.

  • Branded statins like atorvastatin (Lipitor) and rosuvastatin (Crestor) have historically dominated the market, but the introduction of generics has significantly altered market dynamics. For example, after the introduction of generic atorvastatin, the market saw a shift towards generic prescriptions, which expanded the market and reduced costs for patients[5].

First-in-Class vs. Best-in-Class

The success of a statin drug is not solely determined by being the first in its class but also by its therapeutic advantage.

  • A study by The Boston Consulting Group found that while being first to market has some advantages, having a proven therapeutic advantage can lead to greater commercial success. For instance, atorvastatin, despite being the fifth statin on the market, achieved nearly double the peak annual sales of other statins in its class[1].

Timing of Market Entry

The timing of market entry is critical for statin drugs.

  • Fast followers, or drugs that enter the market shortly after the first-in-class drug, can capture significant market share if they offer a therapeutic advantage. However, the window for successful fast followers is narrow; drugs entering the market 2-5 years after the first-in-class drug achieve only about 38% of the value of those entering within 2 years[1].

Therapeutic Advantage

The therapeutic advantage of a statin drug is a key determinant of its commercial success.

  • Drugs with a higher therapeutic advantage, as measured by their ability to address patient needs, tend to capture more market value. For example, statins like rosuvastatin, which have been shown to have a strong lipid-lowering effect and reduce the risk of cardiovascular events, have a significant market presence[2][4].

Market Dynamics in Different Regions

Market dynamics can vary significantly across different regions.

  • In South Korea, for instance, the statin market is highly dynamic, with changes in prescription patterns and market penetration driven by the introduction of generics and changes in healthcare policies. The use of moderate-intensity statins increased from 57% in 2003 to 92% in 2015, and the market saw significant expansion after the introduction of generics[4].

Financial Burden and Cost-Effectiveness

The financial burden of statin therapy can be significant, but these drugs are often cost-effective in the long term.

  • Patients' financial status and the costs associated with prescribed statins can be a considerable burden. However, studies have shown that statins are cost-effective, especially when considering the reduction in cardiovascular events and hospitalizations. For example, long-term use of statins has been shown to lower the risk of rehospitalization due to ischemic stroke[2][5].

Future Outlook and Opportunities

The future outlook for statin drugs, including BARSTATIN 100, is promising due to several factors:

  • Growing Demand: The increasing prevalence of hypercholesterolemia and the expanding use of statins in various therapeutic areas will continue to drive demand.
  • Generic Market: The introduction of generics will continue to shape the market, offering more affordable options for patients and potentially expanding the market size.
  • Innovative Formulations: New formulations and combinations of statins with other lipid-lowering agents could offer additional therapeutic advantages and market opportunities[3][4].

Case Study: Atorvastatin (Lipitor)

Atorvastatin, one of the most successful statins, provides a valuable case study.

  • Despite being the fifth statin on the market, atorvastatin achieved peak annual sales of $13 billion, highlighting the importance of therapeutic advantage over being first to market. Its success can be attributed to its strong lipid-lowering efficacy and extensive marketing efforts[1].

Market Penetration and Switching

Market penetration and drug switching are important aspects of statin market dynamics.

  • In Korea, for example, the introduction of generics led to significant market penetration and switching from branded to generic statins. This trend is expected to continue as more generics enter the market[4].

Regulatory and Healthcare Policy Impact

Regulatory changes and healthcare policies significantly influence the statin market.

  • Guidelines such as the 2013 ACC/AHA cholesterol treatment guidelines in the U.S. have impacted statin utilization trends and expenditures. These guidelines often lead to changes in prescription patterns and market dynamics[5].

Financial Projections

Financial projections for statin drugs like BARSTATIN 100 depend on several factors, including market entry timing, therapeutic advantage, and regulatory environment.

  • For instance, if BARSTATIN 100 enters the market with a strong therapeutic advantage and within a short time frame after the first-in-class drug, it could capture a significant market share. However, if it enters late or without a clear therapeutic advantage, its financial trajectory may be less favorable[1][3].

Key Takeaways

  • Market Size and Growth: The statin market is substantial and growing.
  • First-in-Class vs. Best-in-Class: Therapeutic advantage is more important than being first to market.
  • Timing of Market Entry: Fast followers can capture significant market share if they enter quickly.
  • Therapeutic Advantage: Strong lipid-lowering efficacy and reduction in cardiovascular events are key.
  • Market Dynamics: Vary significantly across regions and are influenced by generics and healthcare policies.
  • Financial Burden and Cost-Effectiveness: Statins are cost-effective despite initial financial burdens.
  • Future Outlook: Promising due to growing demand, generic market, and innovative formulations.

FAQs

Q: What is the current market size for statin drugs?

The current market size for statin drugs is approximately $28.5 billion globally, as of 2014[4].

Q: How important is being the first statin to market?

Being the first statin to market has some advantages, but having a proven therapeutic advantage is more crucial for commercial success[1].

Q: What is the impact of generic statins on the market?

The introduction of generic statins significantly expands the market and reduces costs for patients, leading to increased market penetration and switching from branded to generic statins[4][5].

Q: How do regulatory changes affect the statin market?

Regulatory changes, such as new treatment guidelines, can impact statin utilization trends and expenditures, leading to changes in prescription patterns and market dynamics[5].

Q: What are the key factors influencing the financial trajectory of a new statin drug like BARSTATIN 100?

The key factors include the timing of market entry, therapeutic advantage, and the regulatory environment. A strong therapeutic advantage and quick market entry are crucial for capturing significant market share[1][3].

Sources

  1. What matters most in commercial success: first-in-class or best-in-class - The Boston Consulting Group.
  2. Long-Term Use of Statins Lowering the Risk of Rehospitalization ... - Frontiers in Pharmacology.
  3. A Multi-Billion-Dollar Drug Market - Baron Funds.
  4. Patterns of statin utilisation for new users and market dynamics in ... - BMJ Open.
  5. Statins utilization trends and expenditures in the U.S. before and ... - ScienceDirect.

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