NEXAVAR Drug Patent Profile

Which patents cover Nexavar, 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
Disruptive Pharma	EARLY_PHASE1
CTC Clinical Trial Consultants AB	EARLY_PHASE1
Guangzhou First People's Hospital	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

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
Croatia	P20100674
Argentina	054234	COMPOSICION FARMACEUTICA PARA EL TRATAMIENTO DEL CANCER
South Korea	20070020158
Slovenia	1140840

Supplementary Protection Certificates for NEXAVAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	06C0034	France		PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719
1140840	122006000059	Germany		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
1140840	91280	Luxembourg		91280, EXPIRES: 20210720
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

Last updated: August 21, 2025

Introduction

NEXAVAR (sorafenib) represents a pivotal oral multikinase inhibitor, chiefly utilized in the treatment of advanced hepatocellular carcinoma (HCC), renal cell carcinoma (RCC), and differentiated thyroid carcinoma (DTC). Since its FDA approval in 2005, NEXAVAR has established itself within the targeted oncology drug landscape, navigating complex market dynamics shaped by clinical efficacy, competitive pressures, regulatory landscapes, and evolving treatment paradigms. Analyzing its current market position and projected financial trajectory offers vital insights for stakeholders in pharmaceutical development, investment, and healthcare management.

Market Dynamics of NEXAVAR

1. Therapeutic Market Landscape

NEXAVAR primarily competes in niche but rapidly expanding oncology segments:

• Hepatocellular carcinoma: Globally, HCC remains the sixth most common cancer and the third leading cause of cancer-related mortality, with an estimated 906,000 new cases in 2020 [1]. The limited efficacy of traditional chemotherapies has propelled the preference for targeted therapies like sorafenib, positioning NEXAVAR as a front-line treatment since its approval.

• Renal cell carcinoma: RCC accounts for approximately 3% of adult malignancies, with clear cell subtype constituting the majority. The advent of targeted therapies has shifted treatment protocols from cytokine-based therapies to kinase inhibitors like NEXAVAR.

• Differentiated thyroid carcinoma: Though less prevalent, radioactive iodine-refractory DTC has seen NEXAVAR as a sanctioned option, further diversifying its market scope.

2. Competitive Landscape

Key competitors include:

• Lenvatinib (Lenvima): Approved for HCC and thyroid cancers, often positioned as a superior alternative to sorafenib due to differing efficacy profiles.

• Regorafenib (Stivarga): Used in second-line treatment for HCC and RCC, offering competition in treatment sequencing.

• Cabozantinib (Cabometyx): Notable for expanded indications, such as medullary thyroid carcinoma, and rivaling sorafenib’s efficacy.

• Emerging therapies: Immunotherapies like nivolumab and pembrolizumab are increasingly incorporated into treatment regimens, challenging the market share of kinase inhibitors.

3. Regulatory and Pricing Dynamics

• Regulatory approvals: NEXAVAR holds approvals across numerous countries, but regulatory environments vary, affecting market access. Notably, the introduction of biosimilars or generics can erode market share.

• Pricing and reimbursement: Cost-effectiveness remains crucial. In payor-driven markets such as the US and Europe, reimbursement policies influence utilization rates. Patent expiry and resultant generics could significantly reduce prices, impacting revenue streams.

4. Geographic Market Penetration

• North America and Europe: Mature markets with high penetration; however, growth is constrained by emerging competition and biosimilar entry.

• Asia-Pacific: A significant growth opportunity driven by high HCC prevalence, expanding healthcare infrastructure, and increasing adoption of targeted therapies.

• Emerging markets: Growth is facilitated by increasing disease burden and expanding healthcare budgets but faces challenges such as affordability and infrastructure limitations.

5. Clinical and Scientific Developments

Recent trials explore NEXAVAR's combination with immunotherapies (e.g., atezolizumab), aiming to improve efficacy in HCC and other cancers, potentially redefining its market position. The evolving evidence base influences both clinical guidelines and treatment algorithms, impacting demand.

Financial Trajectory of NEXAVAR

1. Revenue Trends

• Historical revenue: NEXAVAR generated approximately $700 million globally in 2018, with strong markets in the US and Europe before plateauing due to patent protections and emerging generics.

• Recent performance: Sales have faced downward pressure with patent expirations, biosimilar competition, and the advent of alternative therapies. A decline of roughly 10-15% annually observed in the last few years is anticipated if no new indications or formulations emerge.

2. Impact of Patent Expiry and Generics

• The patent for sorafenib expired in key markets like the EU in 2016 and in the US in 2017, leading to the entry of generics which significantly reduced pricing and revenue.

• This erosion is projected to continue, with forecasts indicating a decline in branded revenue to below $200 million globally by 2025 unless new indications or improved formulations are introduced.

3. Pipeline and Indication Expansion

• Combination therapies: Trials combining sorafenib with immune checkpoint inhibitors could repurpose the drug and extend its lifecycle. Positive outcomes may revive sales and attract new procurement.

• New formulations: Development of sustained-release formulations or enhanced delivery mechanisms could command premium pricing and expand indications.

4. Licensing and Market Access Strategies

• Licensing agreements in emerging markets bolster revenues.

• Strategic collaborations for combination therapies and companion diagnostics can facilitate wider adoption and secure market share.

5. Cost and Investment Considerations

• R&D investments for new indications or formulations require significant capital but are crucial for reversing sales declines.

• Regulatory costs and market access strategies significantly influence the financial trajectory, particularly in markets with stringent approval processes.

Key Factors Shaping Future Market and Financial Performance

Factor	Impact on NEXAVAR	Trend Outlook
Patent expirations	Market share erosion	Negative, unless mitigated
Emergence of immunotherapies	Increased competition	Competitive pressure intensifies
Clinical trials for new combos	Opportunity for repositioning	Potential positive
Regional market growth	Expanding adoption	Positive, especially APAC
Pricing pressure	Revenue decline	Likely to persist

Strategic Outlook for 2023-2028

• Short-term: Revenue declines due to patent expiries; companies focus on biosimilar market strategies.

• Mid-term: Successful demonstration of combination therapies or new indications could stabilize or grow revenues.

• Long-term: Diversification into novel formulations and integration into combination regimens may extend the product’s lifecycle.

Conclusion

NEXAVAR's market dynamics are shaped by patent expiries, intense competition, and evolving therapeutic landscapes. Its financial future hinges on successful pipeline innovations, strategic collaborations, and adaptation to emerging treatment paradigms. While combining traditional kinase inhibition with immunotherapy offers promising avenues, the landscape remains highly competitive, necessitating vigilant market analysis and agile strategic planning.

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Key Takeaways

• Market saturation and patent expirations have led to revenue declines, emphasizing the importance of innovation and pipeline development for NEXAVAR.

• Emerging immunotherapy combinations could rejuvenate sales, positioning NEXAVAR as part of synergistic treatment regimens.

• Geographic expansion, particularly in Asia-Pacific, offers growth potential driven by increasing HCC prevalence and healthcare infrastructure development.

• Prices and reimbursement policies remain key determinants; biosimilar entry pressures margins and future profitability.

• Strategic focus on combination therapies and new formulations is vital for extending product lifecycle and financial viability.

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FAQs

1. How has patent expiration affected NEXAVAR's market share and revenue?
Patent expiration in key markets has facilitated biosimilar entry, leading to significant reductions in pricing and volume, causing an estimated revenue decline of 10-15% annually since 2016 in established markets.

2. What are the main competitive threats to NEXAVAR in the oncology market?
Rival kinase inhibitors like lenvatinib, regorafenib, and cabozantinib, alongside emerging immunotherapies such as nivolumab, threaten NEXAVAR’s market share, especially given their comparable or superior efficacy profiles and expanding indications.

3. Can combination therapies involving NEXAVAR extend its market presence?
Yes. Clinical trials exploring NEXAVAR combined with immune checkpoint inhibitors have shown promise, potentially leading to new approvals and restoring growth avenues.

4. What regions offer the highest growth potential for NEXAVAR?
The Asia-Pacific region, due to high HCC burden and expanding healthcare systems, provides significant growth opportunities, complemented by emerging markets with increasing treatment adoption.

5. What strategic moves should manufacturers consider to enhance NEXAVAR’s financial trajectory?
Focusing on pipeline diversification, developing new formulations, exploring combination regimens, and forging strategic regional partnerships are essential for mitigating revenue decline and capturing new market segments.

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Sources:

[1] Global Cancer Observatory (GLOBOCAN) 2020. International Agency for Research on Cancer.