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Last Updated: December 27, 2024

SALURON Drug Patent Profile


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

Saluron is a drug marketed by Shire Llc and is included in one NDA.

The generic ingredient in SALURON is hydroflumethiazide. There are two drug master file entries for this compound. Additional details are available on the hydroflumethiazide profile page.

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Summary for SALURON
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 82
Patent Applications: 3,790
DailyMed Link:SALURON at DailyMed
Drug patent expirations by year for SALURON

US Patents and Regulatory Information for SALURON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Llc SALURON hydroflumethiazide TABLET;ORAL 011949-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

SALURON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pharmaceutical Drugs: A Case Study Approach

Introduction

Understanding the market dynamics and financial trajectory of pharmaceutical drugs is crucial for companies, investors, and healthcare providers. This article will delve into the key factors influencing the market and financial performance of pharmaceuticals, using the context of drugs like SALURON as a reference point.

Market Structure and Competition

The pharmaceutical market is characterized by varying levels of competition, patent protection, and promotional expenditures. For instance, markets with few sellers and strong patent protection, such as those for oral diuretics, often exhibit high promotional expenditures. In contrast, markets with many competitors and no significant patents, like the antianginal drug market, can still see high promotional spending, particularly from non-leading firms[1].

Role of Patent Protection

Patent protection significantly influences market dynamics. Drugs with strong patent protection, such as novel injectable drugs, can enjoy a first-mover advantage, especially if they expand indications quickly within the first five years of launch. This can result in a market share 13 percentage points above the fair market share[4].

Promotional Expenditures

Promotional spending is a critical aspect of pharmaceutical marketing. Studies have shown that sellers of drugs in competitive markets, even without significant patents, may spend a higher percentage of their sales on promotion. For example, antianginal drugs saw higher promotional expenditures compared to oral diuretics, driven largely by non-leading firms[1].

Impact of Media Coverage

Media coverage of drug prices can significantly affect the financial performance of pharmaceutical companies. Research indicates that frequent and intense media coverage of drug price increases can lead to reduced stock value and lower financial metrics such as net margin and return on equity[3].

High-Cost Therapies and Formulary Management

The rise of high-cost therapies, including specialty and orphan drugs, is reshaping the pharmaceutical market. Health systems must carefully evaluate the financial and operational implications of these therapies, including the cost of goods and the cost to deliver the service. This involves collaborating with finance and revenue cycle teams to assess sustainability and impact on revenue[2].

Distribution Channels and Business Models

The pharmaceutical distribution landscape is evolving, with new business models and distribution channels emerging. Prescription benefit managers (PBMs) are shifting from rebate-driven models to administrative and service fee models, and direct contracting with manufacturers is becoming more prevalent. This requires health systems and pharmacies to adapt their strategies to maintain relevance[2].

Financial Performance and Capitalization

The financial performance of pharmaceutical companies is closely tied to their market share, pricing strategies, and the efficiency of their distribution networks. Companies that are first to market can enjoy significant advantages, but late entrants can also succeed if they differentiate their products or offer better value propositions[4].

Value-Based Contracting

Health systems are increasingly adopting value-based contracting for high-value, high-cost medications. This approach involves evaluating the overall value of a drug, including its efficacy, safety, and the cost to deliver the service, rather than just the cost of the drug itself. This strategy helps in aligning financial incentives with patient outcomes[2].

Formulary Management Processes

Effective formulary management is essential for health systems to navigate the complexities of high-cost therapies. This involves rapid decision-making processes, collaboration between different departments, and post-implementation monitoring of reimbursement and revenue integrity. Integrating formulary management tools into electronic health records (EHRs) can also enhance decision-making[2].

Patient Access and Complexity of Distribution

Different drug types operate differently in terms of access, distribution channels, and buying strategies. For example, specialty drugs like glucagon-like peptide 1 agonists may be launched direct-to-consumer due to low uptake by pharmacies. Understanding these complexities is crucial for ensuring patient access and managing costs effectively[2].

Regulatory Environment

Regulatory changes, such as those outlined in the Food and Drug Administration Amendments Act of 2007, can impact the financial trajectory of pharmaceutical companies. These regulations often involve adjustments to fees, inflation adjustments, and public-private partnerships, which can affect the cost of bringing drugs to market[5].

Market Shifts and Adaptation

The pharmaceutical market is subject to various shifts, including changes in profitability due to government price caps and the diminishing return on generic drugs. Retail pharmacies and PBMs must adapt their business strategies to these changes, focusing on new archetypes such as specialty and orphan drugs[2].

Key Takeaways

  • Market Structure: The level of competition and patent protection significantly influences promotional expenditures and market share.
  • Media Impact: Media coverage of drug prices can affect financial performance and investor confidence.
  • High-Cost Therapies: Careful evaluation of financial and operational implications is necessary for high-cost therapies.
  • Distribution Channels: New business models and distribution channels are emerging, requiring adaptation by health systems and pharmacies.
  • Value-Based Contracting: Aligning financial incentives with patient outcomes through value-based contracting is increasingly important.
  • Formulary Management: Rapid decision-making and collaboration between departments are essential for effective formulary management.

FAQs

What is the impact of media coverage on pharmaceutical companies' financial performance?

Media coverage of drug prices can significantly reduce a pharmaceutical company's stock value and lower financial metrics such as net margin and return on equity[3].

How does patent protection influence the market dynamics of pharmaceutical drugs?

Patent protection can provide a first-mover advantage, especially if the first mover expands indications quickly within the first five years of launch, resulting in a higher market share[4].

What are the challenges in managing high-cost therapies in health systems?

Managing high-cost therapies involves evaluating the financial and operational implications, including the cost of goods and the cost to deliver the service, and collaborating with finance and revenue cycle teams[2].

How are distribution channels and business models evolving in the pharmaceutical industry?

New business models, such as direct contracting with manufacturers and shifting from rebate-driven to administrative and service fee models, are emerging and require health systems and pharmacies to adapt[2].

What is the importance of value-based contracting in the pharmaceutical industry?

Value-based contracting aligns financial incentives with patient outcomes, evaluating the overall value of a drug beyond just its cost, which helps in improving patient care and financial sustainability[2].

Sources

  1. Federal Trade Commission. Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets. 1977.
  2. American Society of Health-System Pharmacists. Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs. 2024.
  3. ScholarWorks at Walden University. Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies’ Financial Results. 2024.
  4. McKinsey & Company. Pharma's first-to-market advantage.
  5. U.S. Government Publishing Office. Food and Drug Administration Amendments Act of 2007. 2007.

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