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Last Updated: April 25, 2025

OSHIH Drug Patent Profile


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Summary for OSHIH
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:OSHIH at DailyMed
Drug patent expirations by year for OSHIH

US Patents and Regulatory Information for OSHIH

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Aurobindo Pharma OSHIH ethinyl estradiol; norethindrone acetate TABLET;ORAL 216558-001 Dec 6, 2023 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 1 of 1 entries

Market Dynamics and Financial Trajectory in the Pharmaceutical Industry

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by various factors including regulatory changes, technological advancements, and shifting market demands. This article will delve into the market dynamics and financial trajectories that shape the pharmaceutical industry, using relevant examples and data to illustrate key points.

Global Pharmaceutical Market Overview

The global pharmaceutical market is projected to grow significantly, with revenues expected to reach $1.15 trillion in 2024 and exceed $1.4 trillion by 2028. This growth is driven by the increasing global burden of chronic diseases, such as cancer, diabetes, and cardiovascular diseases[3].

Trends in Prescription Drug Spending

Between 2016 and 2021, prescription drug spending in the U.S. increased from $520 billion to $603 billion, a 16% rise. This growth was largely driven by increases in spending per prescription rather than an increase in the number of prescriptions. Retail drug expenditures accounted for about 70% of total prescription drug spending, while non-retail expenditures made up the remaining 30%[1].

Specialty and High-Cost Drugs

Specialty drugs have become a significant segment of the pharmaceutical market. Between 2016 and 2021, specialty drug spending increased by 43%, reaching $301 billion in 2021. Despite a minimal increase in the number of specialty prescriptions, the spending on these drugs rose substantially due to higher costs per prescription. Non-retail specialty drug spending saw a 20% increase over this period, while retail specialty drug spending increased by 22%[1].

Investment Trends in Pharmaceutical Research and Development

The cost of bringing a new drug to market is approximately $2.6 billion, with a development timeline of 10 to 15 years. The success rate for drug candidates entering clinical trials is only about 10%, highlighting the high risks involved in pharmaceutical R&D. Despite these challenges, successful drugs can generate substantial revenue streams. For example, AbbVie's Humira, a monoclonal antibody for autoimmune diseases, generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023[3].

Return on Investment (ROI) for Pharmaceutical R&D

The ROI for pharmaceutical R&D has been declining. According to Deloitte's 2022 analysis, the projected ROI for the 20 largest pharmaceutical companies was just 1.2%, down from 1.9% in 2021. This decline is attributed to increasing regulatory costs, shorter exclusivity periods, and the impact of generic and biosimilar competitors[3].

Regional Market Dynamics

Japan

Japan's pharmaceutical market is expected to grow at a slower rate compared to the global market, with a projected annual growth rate of 0.5-1.5% through 2027. This slow growth is partly due to a decline in the off-patent drug market and a "drug lag" where fewer new medicines are available in Japan compared to other countries. However, the patented drug market, including biologics, is expected to continue growing[4].

Europe and the Americas

Companies like Servier have seen significant growth in both European and American markets. Servier's consolidated revenue increased by 9.2% in the 2022-2023 financial year, with brand-name medicine revenue up by 9.4% and generics revenue up by 8.8%. International revenue, particularly from the American continent, has been a key driver of growth for such companies[2].

Financial Performance of Pharmaceutical Companies

Revenue and Profitability

Pharmaceutical companies often experience fluctuating financial performance due to factors like patent expirations and regulatory changes. For instance, Servier's EBITDA margin increased to 19.1% in the 2022-2023 financial year, but the company reported a net loss of €623 million due to legal and tax-related issues[2].

Funding and Clinical Trials

Biotechnology companies, such as OS Therapies, often rely on funding to advance their clinical trials. OS Therapies reported a net operating loss but secured significant funding to continue its Phase 2b clinical trial for OST-HER2, a treatment for osteosarcoma. This funding is crucial for meeting key clinical and regulatory milestones before generating revenue[5].

Regulatory Environment

The regulatory environment plays a critical role in shaping the pharmaceutical market. Changes in drug pricing systems, as seen in Japan, can significantly impact the availability and profitability of new medicines. The Japanese government's efforts to reform the drug pricing system to better reward innovation are seen as positive steps by the industry[4].

Market Challenges and Opportunities

High Development Costs and Risk

The high cost and risk associated with drug development are significant challenges. However, successful drugs can offer substantial rewards, making the investment worthwhile for many companies.

Generic and Biosimilar Competition

The entry of generic and biosimilar drugs into the market can rapidly erode the sales of brand-name drugs, impacting the ROI for pharmaceutical R&D. This competition necessitates continuous innovation and strategic planning by pharmaceutical companies[3].

Growing Demand for Chronic Disease Treatments

The increasing global burden of chronic diseases presents a vast market opportunity for pharmaceutical companies. Investing in R&D to address these unmet medical needs can drive future growth and innovation in healthcare[3].

Key Takeaways

  • Global Growth: The global pharmaceutical market is projected to exceed $1.4 trillion by 2028, driven by the growing burden of chronic diseases.
  • Specialty Drugs: Specialty drug spending has seen significant growth, driven by higher costs per prescription.
  • R&D Challenges: The cost and risk of drug development are high, but successful drugs can generate substantial revenue.
  • Regional Dynamics: Different regions have unique market dynamics, with Japan facing slower growth due to a decline in off-patent drugs and a "drug lag."
  • Regulatory Impact: Changes in regulatory environments can significantly affect the profitability and availability of new medicines.

FAQs

Q: What is the projected growth of the global pharmaceutical market? A: The global pharmaceutical market is projected to reach $1.15 trillion in 2024 and exceed $1.4 trillion by 2028[3].

Q: What drives the increase in prescription drug spending? A: The increase in prescription drug spending is primarily driven by higher spending per prescription rather than an increase in the number of prescriptions[1].

Q: How does the ROI for pharmaceutical R&D compare to previous years? A: The ROI for pharmaceutical R&D has been declining, with a projected ROI of 1.2% in 2022, down from 1.9% in 2021[3].

Q: What are the key challenges in pharmaceutical R&D? A: The key challenges include high development costs, long development timelines, and a low success rate for drug candidates entering clinical trials[3].

Q: How does the regulatory environment impact pharmaceutical companies? A: Changes in regulatory environments, such as drug pricing systems, can significantly affect the profitability and availability of new medicines[4].

Sources

  1. Trends in Prescription Drug Spending, 2016-2021 - ASPE
  2. Servier Group Consolidated Revenue - Servier
  3. Investment Trends in Pharmaceutical Research - DrugBank Blog
  4. Japan - Pharmaceuticals - International Trade Administration
  5. OS Therapies Reports Second Quarter 2024 Financial Results - BioSpace

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.