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, Apotex, Dr Reddys, Mylan, Teva Pharms Usa Inc, Torrent, and Yabao Pharm, and is included in seven 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:	7
NDAs:	7
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	164
Patent Applications:	3,002
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
Maternal and Child Health Hospital of Foshan	Phase 2/Phase 3
First Affiliated Hospital of Shantou University Medical College	Phase 2/Phase 3
Third Affiliated Hospital, Sun Yat-Sen 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
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	8,877,933		Y	Y
Teva Pharms Usa Inc	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	209567-001	Nov 12, 2020	AB	RX	No	No
Torrent	SORAFENIB TOSYLATE	sorafenib tosylate	TABLET;ORAL	217095-001	Apr 12, 2023	AB	RX	No	No
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
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	9,737,488		Y

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	8,618,141
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	7,235,576
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	8,841,330
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	8,124,630
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	7,897,623
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	7,351,834

International Patents for sorafenib tosylate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2420283	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОМЕГАКАРБОКСИАРИЛЗАМЕЩЕННУЮ ДИФЕНИЛМОЧЕВИНУ, ДЛЯ ЛЕЧЕНИЯ РАКА (PHARMACEUTIC COMPOSITION CONTAINING OMAGACARBOXYARYL-SUBSTITUTED DIPHENYL UREA FOR CANCER TREATMENT)
Peru	20060699	FORMA TERMODINAMICAMENTE ESTABLE DE UNA SAL TOSILATO
Poland	1868579
Brazil	PI0515946	sal de tosilato, sua preparação e uso, bem como composição farmacêutica compreendendo o mesmo
Malaysia	176929	THERMODYNAMICALLY STABLE FORM OF A TOSYLATE SALT
Portugal	1868579

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	PA2006008	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	35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT
1140840	PA 2006 008, C 1140840	Lithuania		PRODUCT NAME: SORAFENIBAS IR FARMACINIU PO?I?RIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719

Market Dynamics and Financial Trajectory for Sorafenib Tosylate

Last updated: August 21, 2025

Introduction
Sorafenib tosylate, commercially known as Nexavar, stands as a pivotal targeted therapy within the oncology pharmacopeia. Approved initially by the U.S. Food and Drug Administration (FDA) in 2007, it is primarily indicated for hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC), and certain thyroid carcinomas. Its unique mechanism as a multikinase inhibitor has fueled both commercial success and ongoing research, influencing market dynamics profoundly. Understanding the current landscape and future financial trajectory of sorafenib requires examining patent statuses, competitive shifts, regulatory trends, and emerging therapeutic strategies.

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Market Overview and Revenue Generation
Since its launch, sorafenib has achieved significant commercial traction, particularly across Asian, European, and North American markets. In 2022, the drug generated estimated global sales exceeding USD 1.3 billion, with stability driven by its essential role in treating several cancers. The drug’s revenue contribution was sustained by its broad-label approvals, despite the advent of next-generation therapies. Notably, in certain markets, generic versions have eroded pricing power, impacting profit margins.

Patent Landscape and Its Influence on Market Dynamics
The original composition patent for sorafenib lapsed in key jurisdictions around 2017–2019, paving the way for generic entrants. This patent cliff has constrained branded sales and intensified price competition. Companies such as Natco Pharma and others have launched generic formulations at significantly reduced prices, increasing overall access but reducing revenue for originator Bayer (the original developer). The expiration of secondary patents, covering manufacturing processes and formulations, further compounded generic penetration.

Emerging Biosimilars and Alternative Therapies
While biosimilars are less relevant for small-molecule kinase inhibitors like sorafenib, the broader landscape has seen increasing competition from alternative targeted therapies and immunotherapies—most notably, immune checkpoint inhibitors such as nivolumab and pembrolizumab, and tyrosine kinase inhibitors like lenvatinib. For HCC, the combination of atezolizumab with bevacizumab has recently gained prominence, shifting treatment paradigms and impacting sorafenib’s market share. These developments have exerted downward pressure on sorafenib’s revenue potential post-patent expiry.

Regulatory and Clinical Trends
Regulatory bodies continually evaluate sorafenib’s efficacy against emerging therapies. Efforts to expand indications, including adjuvant settings or as part of combination therapy, remain ongoing but face challenges due to mixed clinical trial results. For instance, the REFLECT trial demonstrated non-inferiority of lenvatinib over sorafenib in HCC, influencing prescribing patterns. The evolving clinical landscape emphasizes the importance of combination regimens, which may either complement or diminish sorafenib’s market position.

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Financial Trajectory Insights

Post-Patent Revenue Trends
Bayer’s sales of Nexavar peaked around USD 3.1 billion in 2012, with subsequent declines following patent expirations. In 2022, global revenues for the brand stood at approximately USD 600 million, significantly lower but stabilized through strategic licensing agreements and regional market adaptations. Notably, emerging markets in Asia continue to drive volume, compensating somewhat for lower per-unit prices.

Generic and Biosimilar Impact
The entry of generics in 2018–2020 in key markets like India, the European Union, and the United States resulted in a sharp price reduction—sometimes by over 80%. This shift has shifted the profit landscape from innovation-driven revenue to volume-based sales, threatening original patent holders’ profit margins. Bayer’s ongoing strategy involves patent litigation and licensing deals to mitigate revenue erosion.

Pipeline and Combination Strategies
While sorafenib’s direct sales have plateaued, Bayer and other stakeholders explore combination therapies and new indications. Clinical trials assessing sorafenib alongside immune checkpoint inhibitors or anti-angiogenic agents hold promise for expanding its therapeutic utility. Success in these areas could stabilize or augment sales, albeit with commercial and regulatory complexities.

Future Market Growth Prospects
Market analysts project a modest compound annual growth rate (CAGR) of approximately 2–3% for sorafenib until 2030, driven by regional demand and incremental label extensions. However, this outlook remains contingent on the competitive landscape’s evolution, regulatory approvals, and clinical trial outcomes. The rising trend toward personalized medicine and combination therapy also suggests that sorafenib’s role may shift more toward niche indications or as part of combination regimens rather than as a monotherapy.

Pricing and Reimbursement Dynamics
Price competition due to generics and biosimilars, combined with payers’ focus on cost-effectiveness, is likely to further pressure revenue streams. Countries with strict pricing controls, such as in Europe and certain Asian markets, may experience expedited revenue decline for branded formulations. Conversely, emerging markets where affordability remains a challenge may sustain higher volumes.

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Key Drivers and Challenges

• Drivers:

  • Growing incidence of hepatitis-related HCC and RCC globally.
  • Established positioning as first-line therapy in specific cancers.
  • Regional demand in emerging markets.
  • Ongoing clinical research into novel combination therapies involving sorafenib.

• Challenges:

  • Patent expirations leading to generic competition.
  • Competition from newer, targeted agents and immunotherapies.
  • Evolving treatment guidelines favoring combination regimens with superior efficacy.
  • Pricing pressures and reimbursement hurdles.

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Conclusion
The market for sorafenib tosylate has entered a mature phase characterized by reduced branded revenues and intensified competition from generics and alternative therapies. While its clinical utility remains recognized, especially in regions with limited access to newer agents, long-term financial prospects depend on incremental indications, combination strategies, and regional market dynamics. Stakeholders must navigate patent expiration, pricing landscapes, and shifting treatment paradigms to optimize value realization amid evolving oncology treatment markets.

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Key Takeaways

• Patent expirations significantly diminished sorafenib’s exclusivity, leading to increased generic competition and lower revenues.
• Emerging therapies, especially immunotherapy combinations, are replacing sorafenib as first-line options in several indications, impacting future sales.
• Regional market nuances influence revenue trajectories; growing demand persists in emerging markets, offsetting declines elsewhere.
• Strategic collaborations and clinical trials exploring combination regimens could extend sorafenib’s relevance and stabilize revenues.
• Pricing and reimbursement pressures necessitate adaptive market strategies, especially as biosimilar and generic formulations proliferate globally.

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FAQs

1. What are the primary factors influencing sorafenib’s declining sales?
   Patent expirations enabling generics, competition from newer targeted therapies and immunotherapies, and changing clinical guidelines favoring combination treatments have all contributed to sales decline.

2. Can sorafenib be repositioned through new clinical indications?
   Ongoing research aims to expand its use into combination regimens and novel indications; success could prolong its market relevance, but regulatory and clinical validation are critical.

3. How does the entry of biosimilars or generics affect sorafenib’s profitability?
   Generics drastically reduce per-unit prices, eroding profit margins and compelling brand owners to adopt volume-based sales strategies or litigation to defend patent rights.

4. What is the future outlook for sorafenib in the oncology market?
   Market growth is modest, with a CAGR of 2–3%, driven largely by regional demand and potential use in niche combination regimens rather than as a first-line monotherapy.

5. How do regional market dynamics influence sorafenib’s revenue prospects?
   Emerging markets in Asia and Latin America continue to sustain higher volumes, whereas developed markets see declining revenues due to competition and pricing controls.

Sources

1. [1] Bayer AG Financial Reports, 2022.
2. [2] GlobalData, Oncology Market Insights, 2023.
3. [3] FDA Approval and Patent Histories, 2007–2022.
4. [4] MarketWatch, Oncology Drug Market Trends, 2022.
5. [5] ClinicalTrials.gov, Sorafenib Research Studies, 2023.