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Last Updated: March 18, 2025

POSFREA Drug Patent Profile


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When do Posfrea patents expire, and when can generic versions of Posfrea launch?

Posfrea is a drug marketed by Avyxa Holdings and is included in one NDA.

The generic ingredient in POSFREA is palonosetron hydrochloride. There are twenty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the palonosetron hydrochloride profile page.

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Summary for POSFREA
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
What excipients (inactive ingredients) are in POSFREA?POSFREA excipients list
DailyMed Link:POSFREA at DailyMed
Drug patent expirations by year for POSFREA
Pharmacology for POSFREA

US Patents and Regulatory Information for POSFREA

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Avyxa Holdings POSFREA palonosetron hydrochloride SOLUTION;INTRAVENOUS 203050-001 Mar 1, 2016 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Avyxa Holdings POSFREA palonosetron hydrochloride SOLUTION;INTRAVENOUS 203050-002 Mar 1, 2016 RX Yes Yes ⤷  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 2 of 2 entries

Market Dynamics and Financial Trajectory of the Pharmaceutical Industry: Insights for Business Professionals

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including regulatory changes, technological advancements, and shifting market demands. Understanding these dynamics is crucial for business professionals aiming to navigate and succeed in this industry. Here, we will delve into the key trends, challenges, and financial trajectories that shape the pharmaceutical market.

Global Pharmaceutical Market Revenue

The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and is expected to exceed $1.4 trillion by 2028. This exponential growth is driven by the escalating global burden of chronic diseases, such as cancer, autoimmune diseases, and infectious diseases[3].

Investment Trends in Pharmaceutical Research and Development

Challenges in Drug Development

The process of bringing a new drug to market is fraught with challenges. The average cost is approximately $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, due to scientific and regulatory hurdles[3].

Return on Investment (ROI)

Despite the potential rewards, the ROI for pharmaceutical R&D has been declining. Deloitte's analysis for 2022 revealed a forecasted ROI of just 1.2% for the 20 largest pharmaceutical companies, down from 1.9% in 2021. This decline is attributed to stricter regulatory hurdles, shorter exclusivity periods, and the introduction of generic or biosimilar competitors[3].

Prescription Drug Spending Trends

Overall Spending

Between 2016 and 2021, prescription drug spending in the U.S. grew from $520 billion to $603 billion, a 16% increase. This growth was similar to 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 Drugs

Retail drug expenditures represented about 70% of prescription drug spending, while non-retail drugs accounted for about 30%. There was a 13% increase in retail prescription drug spending, driven primarily by a 7% increase in spending per prescription. In contrast, non-retail drug spending increased by 25%, driven by a 19% increase in the number of prescriptions and a 5% increase in spending per prescription[1].

Specialty Drugs

Spending and Utilization

Specialty drug spending increased by 43% between 2016 and 2021, reaching $301 billion. Despite a minimal increase in the number of specialty prescriptions (0.5%), the spending on specialty drugs rose significantly. In retail settings, the share of spending on specialty drugs increased by 22%, while in non-retail settings, it increased by 20%[1].

Market Dynamics: Consolidation and Vertical Integration

Impact on Competition and Prices

The pharmacy market has undergone significant changes, including increased consolidation and vertical integration. This has led to conflicting theories on the impact on competition, drug prices, and access to pharmacy services. Independent pharmacies face rising challenges, while specialty pharmacies and mail-order pharmacies are growing in prominence[4].

Financial Risks and Uncertainties

Developing New Medicines

Developing new medicines, especially antibiotics to combat drug-resistant infections, is costly and time-consuming. The market for these products can be unpredictable, subject to fluctuations in demand. Initiatives like the AMR Action Fund aim to address these challenges by funding biotechnology companies developing new antibiotics[3].

Balancing Profit and Public Health

Economic Models and Incentives

Pharmaceutical companies must balance the need for profit with the imperative of public health. New economic models are needed to incentivize investment in areas like antibiotic development. The emergence of new infectious diseases and the growing threat of antimicrobial resistance highlight the necessity for sustained investment in pharmaceutical R&D[3].

Case Study: Blockbuster Drugs

Example of Humira

AbbVie's monoclonal antibody, Humira, generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023. This example illustrates the potential for blockbuster drugs to generate significant revenue but also underscores the risks associated with patent challenges and the introduction of generic or biosimilar competitors[3].

Future Outlook

Growth in Specific Therapeutic Areas

The oncology market, for instance, represents a vast and expanding opportunity due to the rising incidence of cancer worldwide. By 2040, projections indicate a substantial increase in cancer cases, driving the need for innovative therapies[3].

Key Takeaways

  • The global pharmaceutical market is projected to grow significantly, driven by chronic diseases.
  • The cost and timeline of drug development are substantial, with a low success rate.
  • ROI for pharmaceutical R&D is declining due to regulatory and market challenges.
  • Prescription drug spending is increasing, with a significant share attributed to specialty drugs.
  • Market consolidation and vertical integration are changing the pharmacy landscape.
  • Balancing profit with public health is crucial, especially in areas like antibiotic development.

FAQs

What is the projected global pharmaceutical market revenue by 2028?

The global pharmaceutical market revenue is forecasted to exceed $1.4 trillion by 2028[3].

How much does it cost to bring a new drug to market?

The average cost of bringing a new drug to market is approximately $2.6 billion[3].

What is the primary driver of increased non-retail prescription drug spending?

The primary driver is greater utilization, rather than higher drug prices, with a 19% increase in the number of prescriptions[1].

How has the ROI for pharmaceutical R&D changed in recent years?

The ROI has been declining, from 1.9% in 2021 to 1.2% in 2022, according to Deloitte's analysis[3].

What is the impact of market consolidation on the pharmacy industry?

Market consolidation has led to conflicting theories on its impact on competition, drug prices, and access to pharmacy services, with independent pharmacies facing rising challenges[4].

Sources

  1. Trends in Prescription Drug Spending, 2016-2021 - ASPE
  2. Pathward Financial, Inc. Announces Results for 2024 Fiscal First Quarter - Pathward Financial
  3. Investment Trends in Pharmaceutical Research and Development - DrugBank Blog
  4. Competition, Consolidation, and Evolution in the Pharmacy Market - The Commonwealth Fund
  5. Understanding the Dynamics of Drug Expenditure - IQVIA Institute

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