NEXAVAR Drug Patent Profile

Which patents cover Nexavar, and when can generic versions of Nexavar launch?

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:	152
Clinical Trials:	300
Patent Applications:	119
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
First Affiliated Hospital of Shantou University Medical College	Phase 2/Phase 3
Third Affiliated Hospital, Sun Yat-Sen University	Phase 2/Phase 3
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

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

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

European Patent Office

Germany

Guatemala

Honduras

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Czech Republic	299125	Difenylové mocoviny substituované omega-karboxyarylovou skupinou jako inhibitory rafkinázy, jejich použití a farmaceutické kompozice s jejich obsahem (Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors, their use and pharmaceutical compositions containing thereof)
Uruguay	29410	COMPOSICIONES FARMACÉUTICAS EN BASE A METILAMIDAS DEL ÁCIDO 4-(4-/-3(-4-CLORO-3-TRIFLUOROMETIFENIL)UREIDO)FENOXI)PIRIDIN-2-CARBOXÍLICO, PROCEDIMIENTO DE PREPARACIÓN Y APLICACIONES.
European Patent Office	1868579	COMPOSITION PHARMACEUTIQUE COMPRENANT UNE DIPHÉNYLURÉE SUBSTITUÉE PAR UN OMÉGA-CARBOXYARYLE POUR LE TRAITEMENT DU CANCER (PHARMACEUTICAL COMPOSITION COMPRISING AN OMEGA-CARBOXYARYL SUBSTITUTED DIPHENYL UREA FOR THE TREATMENT OF CANCER)

Supplementary Protection Certificates for NEXAVAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140840	C01140840/01	Switzerland		FORMER OWNER: BAYER HEALTHCARE LLC, US
1140840	CA 2007 00002	Denmark		PRODUCT NAME: SORAFENIB TOSYLAT
1140840	SZ 35/2006	Austria		PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON

Market Dynamics and Financial Trajectory for NEXAVAR (Sorafenib)

Overview of NEXAVAR (Sorafenib)

NEXAVAR, also known as sorafenib, is a multi-kinase inhibitor used primarily in the treatment of renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), and certain types of thyroid cancer. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Forecast

The sorafenib market, which includes NEXAVAR, was valued at USD 1.11 billion in 2024 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].

Key Indications and Market Impact

NEXAVAR is indicated for the treatment of renal cell carcinoma, hepatocellular carcinoma, and certain types of thyroid cancer. The increasing incidence of these cancers, particularly thyroid cancer, has been a significant driver for the market. Epidemiological research has shown an increase in thyroid cancer cases over the last few decades, which is expected to continue driving demand for sorafenib[1].

Market Competitors and Emerging Therapies

The market for sorafenib faces competition from other approved products for the same indications. Drugs like cabozantinib (CABOMETYX) and sunitinib (SUTENT) are also used in the treatment of renal cell carcinoma and hepatocellular carcinoma. The launch of late-stage emerging therapies is expected to significantly impact the market, as these new treatments may offer improved efficacy or safety profiles[4].

Regional Market Analysis

The market for NEXAVAR is analyzed across several major regions, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Each region has its own market dynamics, regulatory environment, and patient population, which influence the overall market size and growth. For instance, the US market and EU5 markets are expected to contribute significantly to the global sales of sorafenib due to high healthcare spending and a large patient base[4].

Regulatory Milestones and Development Activities

NEXAVAR has undergone extensive regulatory evaluations and has achieved several milestones. The drug's mechanism of action, dosage, and administration have been well-documented. Ongoing research and development activities, including clinical trials and pharmacological studies, continue to support its use and potential expansion into new indications[4].

Financial Performance of Key Players

Bayer, the manufacturer of NEXAVAR, has reported significant financial performance in recent years. In 2022, Bayer's Pharmaceuticals division, which includes NEXAVAR, saw sales increase by 1.1% on a currency- and portfolio-adjusted basis, contributing to the overall strong performance of the company. The division's EBITDA before special items rose by 1.6% to 5.873 billion euros, despite higher research and development expenses and procurement costs[2].

Sales and Revenue Trends

The sales of NEXAVAR have been steady, although the market is expected to see moderate growth due to the increasing incidence of the targeted cancers and incremental healthcare spending globally. In the coming years, the market scenario is set to change with extensive research in the treatment of these conditions, which could expand the market size and enable drug manufacturers to penetrate more deeply into the market[4].

SWOT Analysis

Strengths

• Established brand with a strong market presence.
• Approved for multiple indications, including renal cell carcinoma, hepatocellular carcinoma, and certain types of thyroid cancer.
• Comprehensive clinical data supporting its efficacy and safety.

Weaknesses

• Competition from other tyrosine kinase inhibitors.
• High development and marketing costs.
• Patent expiration could lead to generic competition.

Opportunities

• Increasing incidence of targeted cancers.
• Potential expansion into new indications through ongoing research.
• Growing healthcare spending in emerging markets.

Threats

• Emergence of new therapies with potentially better efficacy or safety profiles.
• Regulatory changes and pricing pressures.
• Generic competition post-patent expiration[4].

Clinical Trials and Emerging Data

Clinical trials continue to play a crucial role in the development and market positioning of NEXAVAR. For example, studies comparing sorafenib with other treatments, such as cabozantinib, provide valuable data on its efficacy and safety. Positive outcomes from these trials can enhance its market position and drive sales[3].

Key Takeaways

• Market Growth: The sorafenib market is expected to grow at a CAGR of 1.21% from 2024 to 2031.
• Competition: The market faces competition from other tyrosine kinase inhibitors, and emerging therapies could impact its market share.
• Regulatory Environment: Ongoing regulatory evaluations and clinical trials are crucial for maintaining and expanding its market presence.
• Financial Performance: Bayer’s Pharmaceuticals division, which includes NEXAVAR, has reported strong financial performance, driven by sales growth and efficient management of expenses.

FAQs

Q: What are the primary indications for NEXAVAR (sorafenib)?

A: NEXAVAR is primarily used in the treatment of renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), and certain types of thyroid cancer.

Q: What is the projected market size for sorafenib by 2031?

A: The sorafenib market is projected to reach USD 1.21 billion by 2031[1].

Q: Who is the manufacturer of NEXAVAR?

A: Bayer is the manufacturer of NEXAVAR.

Q: What are some of the key competitors to NEXAVAR in the market?

A: Key competitors include other tyrosine kinase inhibitors such as cabozantinib (CABOMETYX) and sunitinib (SUTENT)[4].

Q: How does the increasing incidence of thyroid cancer impact the market for NEXAVAR?

A: The increasing incidence of thyroid cancer is a significant driver for the market, as it increases the demand for sorafenib and other treatments for this condition[1].

Sources

1. Verified Market Research: Sorafenib Market Size, Share, Scope, Analysis & Forecast.
2. Bayer: Significant growth in sales and earnings.
3. Exelixis: Second Quarter 2020 Financial Results.
4. Research and Markets: Nexavar (Sorafenib) - Drug Insight and Market Forecast - 2030.