Sorafenib tosylate - Generic Drug Details

What are the generic sources for sorafenib tosylate and what is the scope of freedom to operate?

Sorafenib tosylate is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Dr Reddys, Mylan, Teva Pharms Usa Inc, Torrent, and Yabao Pharm, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sorafenib tosylate has eighty-nine patent family members in thirty-nine countries.

There are twelve drug master file entries for sorafenib tosylate. Eight suppliers are listed for this compound.

Summary for sorafenib tosylate

International Patents:	89
US Patents:	2
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	164
Patent Applications:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sorafenib tosylate
DailyMed Link:	sorafenib tosylate at DailyMed

Recent Clinical Trials for sorafenib tosylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Southern Medical University, China	Phase 2/Phase 3
Jiangxi Province Children's Hospital	Phase 2/Phase 3
The First Affiliated Hospital of Nanchang University	Phase 2/Phase 3

See all sorafenib tosylate clinical trials

Pharmacology for sorafenib tosylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sorafenib tosylate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Torrent	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	217095-001	Apr 12, 2023	AB	RX	No	No
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes			Y	Y
Yabao Pharm	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	209050-001	Nov 9, 2022	AB	RX	No	No
Dr Reddys	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	216073-001	Jun 7, 2022	AB	RX	No	No
Teva Pharms Usa Inc	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	209567-001	Nov 12, 2020	AB	RX	No	No
Mylan	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	207012-001	Sep 10, 2020	AB	RX	No	No

Expired US Patents for sorafenib tosylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005

International Patents for sorafenib tosylate

Country	Patent Number	Title	Estimated Expiration
Malaysia	162319	PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER
Cyprus	1113598
Austria	E482693
Japan	5304241
South Korea	20070058537	THERMODYNAMICALLY STABLE FORM OF BAY 43-9006 TOSYLATE
Morocco	29378	COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DIPHENYLUREE SUBSTITUEE PAR UN OMEGA-CARBOXYARYLE POUR LE TRAITEMENT DU CANCER

Supplementary Protection Certificates for sorafenib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	PA2006008,C1140840	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	SZ 35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140840	PA2006008	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	SPC/GB07/004	United Kingdom		PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
1140840	122006000059	Germany		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719

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].