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Last Updated: December 22, 2024

PREDSULFAIR II Drug Patent Profile


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Which patents cover Predsulfair Ii, and what generic alternatives are available?

Predsulfair Ii is a drug marketed by Pharmafair and is included in one NDA.

The generic ingredient in PREDSULFAIR II is prednisolone acetate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone acetate; sulfacetamide sodium profile page.

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Summary for PREDSULFAIR II
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PREDSULFAIR II at DailyMed
Drug patent expirations by year for PREDSULFAIR II

US Patents and Regulatory Information for PREDSULFAIR II

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair PREDSULFAIR II prednisolone acetate; sulfacetamide sodium SUSPENSION/DROPS;OPHTHALMIC 088837-001 Dec 24, 1985 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

PREDSULFAIR II Market Analysis and Financial Projection Experimental

Understanding the Market Dynamics and Financial Trajectory of Prescription Drugs

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including technological innovation, regulatory changes, and market competition. This article delves into the recent trends, drivers, and projections of prescription drug spending, focusing on the U.S. market.

Historical Trends in Prescription Drug Spending

Between 2016 and 2021, total inflation-adjusted expenditures on prescription drugs in the U.S. grew from $520 billion to $603 billion, a 16% increase. This growth was consistent with the overall national health care spending growth, with prescription drugs maintaining approximately an 18% share of total health care expenditures[1].

Retail vs. Non-Retail Prescription Drug Spending

Retail drug expenditures accounted for about 70% of prescription drug spending, while non-retail drugs made up the remaining 30%. Retail prescription drug spending increased by 13% over this period, driven primarily by a 7% increase in spending per prescription rather than an increase in the number of prescriptions. In contrast, non-retail drug spending rose by 25%, with a 19% increase in the number of prescriptions and a 5% increase in spending per prescription[1].

Specialty Drugs: A Growing Segment

Specialty drug spending saw a significant increase of 43% between 2016 and 2021, reaching $301 billion in 2021. Despite a minimal 0.5% increase in the number of specialty prescriptions, the spending on these drugs continued to rise due to higher prices. In retail settings, the share of specialty drug spending increased by 22%, while in non-retail settings, it increased by 20%[1].

Impact of Generic Drugs on Market Dynamics

The generic drug industry plays a crucial role in shaping the pharmaceutical market. Generic drug prices decrease as the number of competitors increases, but they remain above long-run marginal costs until there are at least 8 competitors. This dynamic is influenced by the expected market size and the entry process, where more firms enter markets with greater expected rents. The FDA's approval process and policies, such as increased scrutiny of generic drug applications, also affect the entry and pricing of generic drugs[2].

Factors Influencing Future Spending

Several factors are expected to influence prescription drug spending in the future:

Utilization and New Drugs

Increased utilization and the introduction of new drugs are significant drivers of spending. For example, in 2023, overall pharmaceutical expenditures in the U.S. grew 13.6% due to a 6.5% increase in utilization and a 4.2% increase from new drugs[3].

Price Changes

Price increases also contribute to the growth in spending. Between 2016 and 2021, the average spending per prescription increased by 7% in retail settings and by 5% in non-retail settings[1].

Regulatory and Policy Changes

Regulatory changes and public policies can significantly impact the pharmaceutical market. For instance, changes in FDA approval processes and the adoption of policies affecting generic drug entry can influence competition and prices[2][5].

Projections for 2024

For 2024, overall prescription drug spending is expected to rise by 10.0% to 12.0%. In clinics, an increase of 11.0% to 13.0% is anticipated, while in nonfederal hospitals, the increase is expected to be between 0% and 2.0% compared to 2023. Specialty, endocrine, and cancer drugs are projected to continue driving expenditures[3].

Role of Biosimilars and Cancer Drugs

Biosimilars and cancer drugs are emerging as significant contributors to pharmaceutical expenditures. Biosimilars, in particular, are expected to play a crucial role in reducing costs while maintaining efficacy, especially in the context of increasing competition in the biologic drug market[3].

Supply Chain Dynamics

The pharmaceutical supply chain, including intermediaries such as pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs), influences the final cost of prescription drugs to consumers. The contractual relationships between these intermediaries, manufacturers, and health plan sponsors can affect prices and market competition[5].

Market Competition and Entry Barriers

Market competition in the pharmaceutical industry is influenced by various factors, including the number of competitors, expected market size, and regulatory barriers. Entry into the generic drug market, for example, is affected by FDA approval processes and the presence of other generic producers, which can drive prices down as competition increases[2].

Impact of the COVID-19 Pandemic

Despite the significant disruptions caused by the COVID-19 pandemic, prescription drug spending showed minimal impact. The trends in spending between 2016 and 2021 were largely unaffected by the pandemic, indicating a resilient market[1].

Key Takeaways

  • Growth in Spending: Prescription drug spending has seen a steady increase, driven by higher spending per prescription and increased utilization.
  • Specialty Drugs: Specialty drugs continue to be a significant segment, with spending increasing despite minimal growth in the number of prescriptions.
  • Generic Drugs: Generic drug prices decrease with increased competition, but remain above long-run marginal costs until there are at least 8 competitors.
  • Future Projections: Spending is expected to rise by 10.0% to 12.0% in 2024, driven by new drugs, increased utilization, and price changes.
  • Regulatory Impact: Regulatory changes and public policies significantly influence market dynamics and prices.

FAQs

Q: What drove the increase in prescription drug spending between 2016 and 2021? A: The increase was primarily driven by higher spending per prescription and increased utilization, especially in the non-retail sector.

Q: How do generic drugs affect market prices? A: Generic drug prices decrease as the number of competitors increases, approaching long-run marginal costs when there are at least 8 competitors.

Q: What is the expected growth in prescription drug spending for 2024? A: Overall spending is expected to rise by 10.0% to 12.0%, with clinics seeing an increase of 11.0% to 13.0% and nonfederal hospitals experiencing a 0% to 2.0% increase.

Q: How do regulatory changes impact the pharmaceutical market? A: Regulatory changes, such as FDA approval processes and policies affecting generic drug entry, can influence competition and prices in the market.

Q: What role do biosimilars play in the pharmaceutical market? A: Biosimilars are expected to reduce costs while maintaining efficacy, especially in the biologic drug market, and are projected to be significant contributors to future expenditures.

Sources

  1. Trends in Prescription Drug Spending, 2016-2021 - ASPE
  2. Generic Drug Industry Dynamics - Federal Trade Commission
  3. National trends in prescription drug expenditures and projections for 2024 - PubMed
  4. Understanding the Dynamics of Drug Expenditure - IQVIA
  5. Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics - Federal Trade Commission

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