NEXAVAR Drug Patent Profile

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

Nexavar is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in thirty-nine countries.

The generic ingredient in NEXAVAR is sorafenib tosylate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nexavar

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

Summary for NEXAVAR

International Patents:	89
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	301
Patent Applications:	1,753
Drug Prices:	Drug price information for NEXAVAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEXAVAR
What excipients (inactive ingredients) are in NEXAVAR?	NEXAVAR excipients list
DailyMed Link:	NEXAVAR at DailyMed

See drug prices for NEXAVAR

Recent Clinical Trials for NEXAVAR

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

Sponsor	Phase
CTC Clinical Trial Consultants AB	EARLY_PHASE1
Disruptive Pharma	EARLY_PHASE1
Southern Medical University, China	Phase 2/Phase 3

See all NEXAVAR clinical trials

Pharmacology for NEXAVAR

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for NEXAVAR

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 NEXAVAR

NEXAVAR is protected by four US patents.

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			Y	Y
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes			Y

Expired US Patents for NEXAVAR

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 NEXAVAR

When does loss-of-exclusivity occur for NEXAVAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NEXAVAR around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	337326
Canada	2549558	DIPHENYLUREES A SUBSTITUANTS OMEGA-CARBOXYARYLES, INHIBITRICES DE KINASE RAF (OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE INHIBITORS)
Spain	2387812
Japan	2007302687	ARYLUREA HAVING ANGIOGENESIS INHIBITING ACTIVITY
Croatia	P20010580	OMEGA-KARBOKSIARIL SUPSTITUIRANE DIFENILNE UREE KAO INHIBITORI RAF KINAZ (OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREAS AS RAF KINASE INHIBITORS)
Austria	520663

Supplementary Protection Certificates for NEXAVAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT
1140840	295	Finland
1140840	PA2006008,C1140840	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 031/2006	Ireland		SPC 031/2006: 20070528, EXPIRES: 20210718
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 NEXAVAR (Sorafenib): A Comprehensive Analysis

Last updated: December 27, 2025

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Executive Summary

NEXAVAR (sorafenib) is a targeted therapy developed by Bayer Pharmaceuticals, primarily used for treating advanced hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), and differentiated thyroid carcinoma (DTC). Since its FDA approval in 2005, NEXAVAR has experienced evolving market dynamics shaped by clinical advancements, competitive landscape shifts, regulatory policies, and emerging treatment paradigms. The drug's financial trajectory reflects steady revenue streams bolstered by expanding indications and regional market penetration, though faced with increasing competition from newer therapies and biosimilars. This report offers an in-depth assessment of the current market environment, forecasted growth, challenges, and strategic considerations relevant to NEXAVAR’s stakeholders.

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Summary of NEXAVAR (Sorafenib)

Attribute	Details
Active Ingredient	Sorafenib
Therapeutic Class	Multikinase inhibitor, Tyrosine kinase inhibitor
Approved Indications	- Hepatocellular carcinoma (2007, FDA) - Renal cell carcinoma (2005, FDA) - Differentiated thyroid carcinoma (2013, FDA)
Manufacturer	Bayer Pharmaceuticals
Global Sales (2022)	Estimated $250 million (varies regionally)
Patent Status	Patent expired or near expiry in multiple jurisdictions, facilitating biosimilar entry

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What Are the Key Market Drivers for NEXAVAR?

Clinical Efficacy and Expanded Indications

NEXAVAR's approvals for multiple cancers have supported sustained demand. Its ability to inhibit tumor proliferation and angiogenesis through VEGFR, PDGFR, and RAF kinases has cemented its role as a front-line therapy in oncology, especially for HCC and RCC.

Rising Incidence of Target Cancers

• Liver cancer (HCC): The global incidence was approximately 906,000 cases in 2020, projected to grow annually (globocan.iarc.fr) [1].
• Renal cell carcinoma: Accounted for 431,000 new cases worldwide in 2020, exhibiting increasing prevalence particularly in North America and Europe.
• Thyroid cancer: Incidence rising due to improved detection; about 43,800 new cases in the U.S. alone (2023 CDC data).

Regional Market Penetration

• Asia-Pacific: Highest usage, driven by HCC prevalence linked to hepatitis infections.
• North America & Europe: Mature markets with high adoption; approaching saturation in some segments.
• Emerging Markets: Growth potential due to increasing cancer screening and healthcare infrastructure expansion.

Regulatory and Reimbursement Policies

Global approval status (FDA, EMA, PMDA) and reimbursement schemes influence adoption rates. Countries with favorable policies for cancer therapies bolster sales.

Competition and Emerging Therapies

Newer targeted agents (lenvatinib, regorafenib) and immunotherapies (nivolumab, pembrolizumab) challenge NEXAVAR’s market share, particularly in RCC and HCC.

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What Are the Market Challenges Facing NEXAVAR?

Challenge	Implication
Patent expiry and biosimilar entry	Price erosion, reduced margins
Competition from immune checkpoint inhibitors	Potential decline in usage in certain indications
Limited efficacy in combination regimens	Growing preference for combination therapies
Side effect profile and tolerability issues	Impact on patient adherence
Regulatory constraints and evolving guidelines	May limit indications or restrict prescribing practices

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Financial Trajectory and Revenue Forecasts

Historical Revenue Trends (2018–2022)

Year	Global Revenue (USD million)	Growth Rate (%)	Notes
2018	310	-	High sales driven by HCC and RCC indications
2019	280	-9.7%	Impacted by increased competition
2020	265	-5.3%	COVID-19 pandemic affected healthcare delivery
2021	255	-3.8%	Slight recovery in select regions
2022	250	-1.6%	Stabilization; emerging biosimilar threats

Forecasted Revenue Trajectory (2023–2027)

Year	Projected Revenue (USD million)	CAGR (%)	Assumptions
2023	245	-2.0%	Slight decline expected due to biosimilar competition and label scope constraints
2024	235	-4.1%	Market saturation in mature regions, new competitors emerging
2025	220	-6.4%	Entry of biosimilars, shifts toward combination and immunotherapy protocols
2026	205	-6.8%	Continued erosion of market share, especially in RCC and HCC indications
2027	190	-7.3%	Evolving landscape with enhanced focus on immunotherapies and combination regimens

Note: Slight revenue declines projected reflecting patent expiration effects, competitive pressures, and shifting treatment paradigms.

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How Does NEXAVAR Compare With Key Competitors?

Parameter	NEXAVAR (Sorafenib)	Lenvatinib (Kisqali)	Regorafenib (Stivarga)	Nivolumab (Opdivo)	Cabozantinib (Cabometyx)
Approval Year	2007 (FDA)	2015	2012	2015	2016
Mechanism	Multikinase inhibitor	Tyrosine kinase inhibitor	Multikinase inhibitor	PD-1 checkpoint inhibitor	Multikinase inhibitor
Primary Indications	HCC, RCC, DTC	HCC, RCC	RCC, HCC	Multiple cancers	RCC, HCC
Annual Sales (2022)	~$250 million	Not publicly available; rapidly growing	Not available	N/A (immunotherapy)	N/A
Patent Status	Near expiry in major markets	Patent active till 2024	Active in some markets	U.S. patent expired	Active until 2027

Note: Competitors like immunotherapies are gaining ground, leading to shifts in market share.

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What Are Future Opportunities for NEXAVAR?

• Combination Therapy Development: Data suggests synergistic benefits when combining sorafenib with immunotherapies; clinical trials are ongoing.
• Biomarker-Driven Approaches: Identifying patient subpopulations more likely to benefit can improve response rates.
• Geographical Expansion: Targeting emerging markets with rising cancer incidences.
• Line Extension and Dosing Optimization: Improved formulations or dosing regimens to enhance tolerability and adherence.
• Strategic Partnerships: Collaborations with biotech firms for novel delivery systems.

How Does Regulatory Policy Shape NEXAVAR’s Market?

• Patent Expiry and Biosimilar Policies: Renewed focus on patent protection and regulatory pathways for biosimilars could accelerate generic entry [2].
• Pricing and Reimbursement Regulations: Stricter cost-effectiveness assessments may limit reimbursement, impacting market access.
• Orphan Drug and Fast-track Designations: Opportunities to extend lifecycle or fast-track approvals in certain indications.

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Conclusion

NEXAVAR remains a key player within the targeted oncology therapy space, with a solid clinical track record and established regional market penetration. However, facing patent expirations, biosimilar competition, and an evolving therapeutic landscape marked by immunotherapies, its financial trajectory is forecasted to experience gradual decline unless strategic adaptations are employed. Market expansion through combination regimens, biomarkers, and emerging regions, coupled with lifecycle management, are critical to sustaining revenue streams.

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Key Takeaways

• Market Size & Growth: The global market for NEXAVAR-related indications was approximately $250 million in 2022, with modest declines forecasted due to patent expiration and competitive pressures.
• Competitive Landscape: Irreversible trends favor immunotherapies, yet NEXAVAR retains niche positioning with potential for combination strategies.
• Strategic Focus: Enhancing combination therapies, expanding to emerging markets, and leveraging regulatory pathways for lifecycle extension are vital growth strategies.
• Implications for Stakeholders: Investors should monitor biosimilar developments and clinical pipeline advancements; manufacturers must innovate to retain market relevance.
• Regulatory Environment: Policy shifts towards biosimilars and cost-containment may accelerate generic entry, pressuring pricing and margins.

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FAQs

1. When is the patent expiration for NEXAVAR in key markets?
Most patents for sorafenib have expired or are nearing expiry, with significant markets facing biosimilar competition by 2024–2025 [2].

2. What are the primary competing drugs for NEXAVAR in HCC and RCC?
Lenvatinib, regorafenib, cabozantinib, and immunotherapies like nivolumab and pembrolizumab are leading competitors, often used in combination or sequential therapies.

3. How effective is combining NEXAVAR with immunotherapies?
Preclinical and early clinical data suggest potential synergy; ongoing trials aim to validate efficacy improvements and safety profiles.

4. Which regions offer the most growth opportunities for NEXAVAR?
Emerging markets in Asia, Latin America, and parts of Africa are promising due to rising cancer incidences and improving healthcare infrastructure.

5. What strategic moves can Bayer pursue to extend NEXAVAR’s market life?
Developing novel formulations, exploring combination regimens, securing new indications, and engaging in strategic partnerships can prolong its relevance.

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References

[1] Globocan 2020: GLOBOCAN estimates of incidence, mortality, and prevalence of primary liver cancer.
[2] FDA and EMA patent status databases; biosimilar entry guidelines (2021–2023).