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Last Updated: December 22, 2024

SOVUNA Drug Patent Profile


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

Sovuna is a drug marketed by Novitium Pharma and is included in one NDA.

The generic ingredient in SOVUNA is hydroxychloroquine sulfate. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydroxychloroquine sulfate profile page.

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

US Patents and Regulatory Information for SOVUNA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novitium Pharma SOVUNA hydroxychloroquine sulfate TABLET;ORAL 214581-001 Jan 14, 2022 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novitium Pharma SOVUNA hydroxychloroquine sulfate TABLET;ORAL 214581-002 Jan 14, 2022 RX Yes Yes ⤷  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

SOVUNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug Industry: Insights and Trends

Introduction

The pharmaceutical industry is a complex and dynamic sector, influenced by a myriad of factors including technological advancements, regulatory changes, market demand, and economic conditions. This article delves into the current market dynamics and financial trajectories of the pharmaceutical industry, using examples and trends to illustrate key points.

Global Pharmaceutical Market Growth

The global pharmaceutical market has seen significant growth over the past few years, driven by various factors such as increasing demand for healthcare services, advancements in medical technology, and the rise of biologic products.

  • Revenue and Volume Growth: Between 2017 and 2022, the U.S. pharmaceutical market saw an 8% growth in volume, while the rest of the world and OECD countries (excluding the U.S.) experienced 13% and 10% volume growth, respectively. However, the U.S. market stood out with higher sales revenue growth compared to other regions[1].

Small Molecule Drugs vs. Biologic Products

The pharmaceutical market is broadly categorized into small molecule drugs and biologic products, each with distinct growth trends.

  • Small Molecule Drugs: These experienced a 4% increase in sales revenues in the U.S. between 2017 and 2022, while the rest of the world and OECD countries saw decreases of 7% and 9%, respectively. Despite this, small molecule drugs still account for the majority of sales, with 57% of U.S. drug sales revenue in 2022[1].

  • Biologic Products: Biologics have seen substantial growth, with a 61% increase in sales revenues in the U.S. and 39% and 33% increases in the rest of the world and OECD countries, respectively. This shift indicates a growing market share for biologic products[1].

Impact of Drug Price News on Financial Performance

Drug price news can significantly impact the financial performance and capitalization of pharmaceutical companies.

  • Media Coverage: Research has shown that mass media coverage of drug prices can affect net margins, return on research capital, return on equity, and market capitalization of pharmaceutical companies. Companies facing negative media coverage over high drug prices often see a reduction in their stock value[3].

Company-Specific Examples

Several pharmaceutical companies have reported notable financial results and strategic moves that reflect broader industry trends.

  • ANI Pharmaceuticals: ANI Pharmaceuticals reported a 12.5% year-over-year growth in net revenues in the third quarter of 2024, driven by strong R&D capabilities and operational excellence. Their generics business saw a 10.8% growth, and their Rare Disease segment, including Cortrophin Gel, saw an 89.8% increase in net revenues[2].

  • Soleno Therapeutics: Soleno Therapeutics made significant progress in the second quarter of 2024, including the submission of a New Drug Application (NDA) for Diazoxide Choline Extended-Release (DCCR) for the treatment of Prader-Willi Syndrome. The company also closed a public offering, raising approximately $158.7 million to support its research and development efforts[5].

Market Trends and Future Outlook

Several trends are shaping the future of the pharmaceutical market.

  • Emergence of New Therapies: The rise of biologic products and innovative therapies like gene editing and precision medicine is expected to continue driving growth in the industry.

  • Regulatory Environment: Changes in regulatory policies and increased scrutiny over drug prices can impact the financial trajectory of pharmaceutical companies. Companies must navigate these challenges while maintaining innovation and profitability.

  • Global Health Crises: The COVID-19 pandemic and other global health crises have accelerated the development and approval of new drugs, highlighting the industry's resilience and adaptability.

Regional Market Dynamics

Regional markets exhibit different dynamics due to varying healthcare systems, regulatory environments, and economic conditions.

  • North America: The region has seen a shift in drug use patterns, particularly with the emergence of fentanyl and other synthetic opioids. This trend is expected to continue, influencing both legal and illicit drug markets[4].

  • Global Markets: The rest of the world and OECD countries have shown different growth patterns compared to the U.S., with higher volume growth but lower revenue growth. This discrepancy highlights the impact of pricing strategies and market conditions on revenue[1].

Financial Performance Metrics

Key financial metrics provide insights into the health and growth potential of pharmaceutical companies.

  • Revenue Growth: Companies like ANI Pharmaceuticals have reported significant revenue growth, driven by both generics and specialty products[2].

  • Research and Development Expenses: Investments in R&D are crucial for innovation. Soleno Therapeutics, for example, has focused heavily on advancing its lead product candidate, DCCR, through late-stage clinical development[5].

  • Gross Margin and EBITDA: Changes in gross margin and EBITDA can indicate shifts in product mix and operational efficiency. ANI Pharmaceuticals saw a decrease in gross margin due to an unfavorable mix of products, while their adjusted non-GAAP EBITDA remained strong[2].

Stakeholder Impact

The financial performance of pharmaceutical companies affects various stakeholders, including investors, patients, and healthcare providers.

  • Investor Interests: Media coverage of drug prices and regulatory changes can significantly impact investor confidence and stock performance[3].

  • Patient Well-being: High drug prices can affect patient access to necessary medications, making it crucial for companies to balance profitability with patient needs.

Regulatory and Policy Influences

Regulatory and policy changes play a critical role in shaping the pharmaceutical market.

  • Price Controls: Discussions around drug price controls and transparency can influence company strategies and financial outcomes.

  • Approval Processes: Streamlined approval processes for new drugs can accelerate market entry and impact revenue growth.

Conclusion

The pharmaceutical industry is characterized by complex market dynamics and significant financial fluctuations. The growth of biologic products, the impact of drug price news, and regional market trends are key factors influencing the industry's financial trajectory. Companies must navigate these challenges while investing in innovation and ensuring patient access to essential medications.

Key Takeaways

  • Biologic Products Growth: Biologics are driving significant growth in the pharmaceutical market.
  • Drug Price News Impact: Media coverage of drug prices can affect financial performance and capitalization.
  • Regional Dynamics: Different regions exhibit unique market trends and growth patterns.
  • Regulatory Influence: Regulatory changes and policy discussions significantly impact the industry.
  • Stakeholder Interests: Financial performance affects investors, patients, and healthcare providers.

FAQs

Q: What is the current trend in the growth of small molecule drugs versus biologic products? A: Small molecule drugs have seen a decline in sales revenue growth, while biologic products have experienced significant growth, with a 61% increase in the U.S. between 2017 and 2022[1].

Q: How does media coverage of drug prices affect pharmaceutical companies? A: Media coverage can impact net margins, return on research capital, return on equity, and market capitalization. Companies facing negative coverage often see a reduction in their stock value[3].

Q: What are some key financial metrics for evaluating pharmaceutical companies? A: Revenue growth, research and development expenses, gross margin, and EBITDA are crucial metrics for assessing a company's financial health and growth potential[2][5].

Q: How do regional market dynamics differ globally? A: Regional markets exhibit different growth patterns due to varying healthcare systems, regulatory environments, and economic conditions. For example, the U.S. market has higher revenue growth but lower volume growth compared to other regions[1].

Q: What role do regulatory changes play in the pharmaceutical industry? A: Regulatory changes, such as price controls and streamlined approval processes, significantly influence company strategies and financial outcomes. These changes can impact revenue growth and profitability[1][3].

Sources

  1. ASPE Analysis of IQVIA MIDAS Data: "International Market Size and Prices" - ASPE Issue Brief.
  2. ANI Pharmaceuticals Financial Report: "ANI Pharmaceuticals Reports Record Third Quarter 2024 Financial Results" - ANI Pharmaceuticals Investor Relations.
  3. Relationship Between Drug Price News and Financial Performance: "Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies’ Financial Results" - Walden University ScholarWorks.
  4. Shifting Drug Markets in North America: "Shifting drug markets in North America - a global crisis in the making?" - PubMed.
  5. Soleno Therapeutics Corporate Update: "Soleno Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results" - Soleno Therapeutics Investor Relations.

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