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Last Updated: December 22, 2024

SORAFENIB TOSYLATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Sorafenib Tosylate

A generic version of SORAFENIB TOSYLATE was approved as sorafenib tosylate by MYLAN on September 10th, 2020.

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Drug patent expirations by year for SORAFENIB TOSYLATE
Recent Clinical Trials for SORAFENIB TOSYLATE

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SponsorPhase
First Affiliated Hospital of Shantou University Medical CollegePhase 2/Phase 3
Second Xiangya Hospital of Central South UniversityPhase 2/Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2/Phase 3

See all SORAFENIB TOSYLATE clinical trials

Pharmacology for SORAFENIB TOSYLATE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for SORAFENIB TOSYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NEXAVAR Tablets sorafenib tosylate 200 mg 021923 1 2014-02-28

US Patents and Regulatory Information for SORAFENIB TOSYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 216073-001 Jun 7, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 217095-001 Apr 12, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 207012-001 Sep 10, 2020 AB RX 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

SORAFENIB TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sorafenib Tosylate

Introduction to Sorafenib Tosylate

Sorafenib tosylate, known by its trade name Nexavar, is a bi-aryl urea compound that acts as a kinase inhibitor. It is primarily used in the treatment of renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), and certain types of thyroid cancer. Here, we delve into the market dynamics and financial trajectory of this critical anticancer drug.

Market Size and Forecast

The global sorafenib market has been experiencing steady growth, driven by several key factors. As of 2024, the market size was valued at approximately USD 1.11 billion and is projected to reach USD 1.21 billion by 2031, growing at a compound annual growth rate (CAGR) of 1.21% from 2024 to 2031[1].

However, different reports provide varying forecasts. For instance, another source indicates that the sorafenib market will grow from $1.19 billion in 2023 to $1.24 billion in 2024 at a CAGR of 4.1%, and is expected to reach $1.47 billion by 2028 at a CAGR of 4.2%[3].

Segmentation by Product

The sorafenib market is segmented into patented drugs and generic drugs. Historically, patented drugs, such as those marketed by Bayer, held the largest market share. However, the expiration of patents has led to a significant rise in the demand for generic sorafenib, particularly in regions like the Asia Pacific[1][3].

Segmentation by Distribution Channel

The market is also segmented by distribution channels, including hospital pharmacies, drug store and retail pharmacies, and online pharmacies. Hospital pharmacies dominate this segment due to the high prevalence of cancer treatments in these settings[3].

Segmentation by Application

Sorafenib is primarily used in the treatment of kidney cancer, liver cancer, and thyroid cancer. The increasing incidence of these cancers, especially thyroid cancer, has been a major driver of the market. For example, the global age-standardized incidence rate of thyroid cancer has increased by approximately 20% in higher-income countries[1][3].

Regional Analysis

Geographically, the sorafenib market is divided into North America, Europe, Asia Pacific, and the rest of the world. North America has dominated the market due to the high prevalence of liver cancer, early diagnosis, and a well-established healthcare infrastructure. The Asia Pacific region is also significant, driven by the growing demand for generic sorafenib[1][3].

Market Drivers

Several factors are driving the growth of the sorafenib market:

  • Rising Prevalence of Cancer: The increasing incidence of kidney, liver, and thyroid cancers is a major driver.
  • Favorable Government Policies and Reimbursement Programs: These policies have made the drug more accessible to patients.
  • Advancements in Early Diagnosis and Treatment: Improved diagnostic techniques and treatment options have enhanced the survival rate of cancer patients.
  • Growing Research Studies: Ongoing research into more effective sorafenib formulations and its potential use in other types of cancer is also driving growth[1][3].

Market Restraints

Despite the growth, there are several restraints:

  • Health Risks Associated with Sorafenib: The drug can have significant side effects, which may limit its use in some patients.
  • Decreasing Sales Due to Patent Expiration: The expiration of patents has led to increased competition from generic drugs, reducing the sales of patented versions.
  • Emergence of New Substitute Drugs: The development of new anticancer drugs could potentially reduce the market share of sorafenib[1][3].

Market Opportunities

There are several opportunities for growth:

  • Ongoing Research Studies: Continuous research into new formulations and applications of sorafenib could expand its market.
  • Technological Innovations in Drug Delivery: Advances in drug delivery systems could improve the efficacy and safety of sorafenib.
  • Increasing Focus on Precision Medicine: The growing emphasis on precision medicine could lead to more targeted and effective use of sorafenib[1][3].

Financial Trajectory

The financial trajectory of sorafenib is complex and influenced by various factors. While the market is expected to grow, the rate of growth varies across different forecasts. Here are some key financial projections:

  • 2023-2024: The market is expected to grow from $1.19 billion to $1.24 billion at a CAGR of 4.1%[3].
  • 2024-2031: The market is projected to grow from $1.11 billion to $1.21 billion at a CAGR of 1.21%[1].
  • 2024-2030: Another forecast suggests a readjusted market size of $786.5 million by 2030 with a CAGR of -2.2%, indicating a potential decline due to increased competition from generics and new drugs[4].

Key Takeaways

  • The sorafenib market is driven by the increasing incidence of kidney, liver, and thyroid cancers.
  • The market is segmented into patented and generic drugs, with generics gaining traction.
  • North America dominates the market due to high cancer prevalence and advanced healthcare infrastructure.
  • Despite growth drivers, the market faces restraints such as health risks and the emergence of new drugs.
  • Ongoing research and technological innovations present opportunities for future growth.

FAQs

Q: What is sorafenib tosylate used for? A: Sorafenib tosylate is used in the treatment of hepatocellular carcinoma (liver cancer), renal cell carcinoma (kidney cancer), and certain types of thyroid cancer[5].

Q: What is the current market size of sorafenib? A: As of 2024, the sorafenib market size was valued at approximately USD 1.11 billion[1].

Q: What is the projected growth rate of the sorafenib market? A: The market is projected to grow at a CAGR of 1.21% from 2024 to 2031, reaching USD 1.21 billion by 2031[1].

Q: Which region dominates the sorafenib market? A: North America dominates the sorafenib market due to the high prevalence of liver cancer and a well-established healthcare infrastructure[1].

Q: What are the main restraints facing the sorafenib market? A: The main restraints include health risks associated with sorafenib, decreasing sales due to patent expiration, and the emergence of new substitute drugs[1][3].

Cited Sources

  1. Verified Market Research - Sorafenib Market Size, Share, Scope, Analysis & Forecast[1].
  2. BPS Bioscience - Sorafenib Tosylate[2].
  3. The Business Research Company - Global Sorafenib Market Report 2024[3].
  4. Valuates Reports - Sorafenib - Market, Report Size, Worth, Revenue, Growth, Industry[4].
  5. National Cancer Institute - Sorafenib Tosylate[5].

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