SUTENT Drug Patent Profile

Which patents cover Sutent, and what generic alternatives are available?

Sutent is a drug marketed by Cppi Cv and is included in one NDA.

The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sutent

A generic version of SUTENT was approved as sunitinib malate by SUN PHARM on August 16^th, 2021.

Summary for SUTENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	221
Drug Prices:	Drug price information for SUTENT
What excipients (inactive ingredients) are in SUTENT?	SUTENT excipients list
DailyMed Link:	SUTENT at DailyMed

See drug prices for SUTENT

Recent Clinical Trials for SUTENT

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
University of Miami	Phase 2
JLLC NatiVita	Phase 1

See all SUTENT clinical trials

Pharmacology for SUTENT

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for SUTENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUTENT	Capsules	sunitinib malate	12.5 mg, 25 mg, 37.5 mg and 50 mg	021938	1	2010-01-26

US Patents and Regulatory Information for SUTENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-001	Jan 26, 2006	AB	RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-003	Jan 26, 2006	AB	RX	Yes	Yes
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-002	Jan 26, 2006	AB	RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009	AB	RX	Yes	No

International Patents for SUTENT

See the table below for patents covering SUTENT around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	0108394
Norway	2010002
Iceland	6501
Taiwan	I306860
Colombia	5280092	INDOLINAS SUSUTITUIDAS CON PIRROLES INHIBIDORAS DE PROTEINQUINASAS
Germany	60129794

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	PA2008002,C1255752	Lithuania		PRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752	91657	Luxembourg		91657, EXPIRES: 20240923
1255752	312	Finland
1255752	2010C/009	Belgium		PRODUCT NAME: TOCERANIB; AUTHORISATION NUMBER AND DATE: EU/2/09/100/001 20090923
1255752	CA 2010 00004	Denmark		PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT
1255752	122008000002	Germany		PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALATSALZES; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060719

SUTENT Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SUTENT (Sunitinib)

Introduction to SUTENT

SUTENT, also known as sunitinib, is a targeted therapy primarily used for the treatment of certain types of cancer, including renal cell carcinoma and gastrointestinal stromal tumors. Developed by Pfizer, it has become a significant player in the oncology drug market.

Market Drivers

Increasing Incidence of Cancer

The rising incidence of cancer, particularly renal cell carcinoma and gastrointestinal stromal tumors, is a major driver of the SUTENT market. As the global population ages and lifestyle factors contribute to higher cancer rates, the demand for effective cancer treatments like SUTENT is increasing[1].

Advancements in Treatment Protocols

Advancements in drug formulations and delivery methods have enhanced patient compliance and treatment outcomes. This includes the development of more tolerable dosing regimens and improved patient management strategies, which have contributed to the market's growth[1].

Growing Demand for Targeted Therapies

There is a growing demand for targeted therapies that offer higher efficacy and reduced side effects compared to traditional chemotherapy. SUTENT's mechanism of action, which targets specific molecular pathways involved in tumor growth, aligns well with this demand[1].

Emerging Markets and Healthcare Infrastructure

Emerging markets, such as those in the Asia-Pacific region, are seeing heightened adoption of SUTENT due to improved healthcare infrastructure and increasing awareness about cancer treatments. Rising disposable incomes in these regions also foster greater treatment adoption[1].

Market Restraints

High Cost of Therapy

One of the significant challenges facing the SUTENT market is the high cost of therapy, which can limit patient accessibility and insurance coverage. This financial barrier affects the market's potential growth, especially in regions with limited healthcare resources[1].

Drug Resistance and Regulatory Challenges

The emergence of drug resistance necessitates the research and development of combination therapies, which can be costly and time-consuming. Additionally, stringent regulatory requirements can delay the approval processes for new formulations, posing another challenge to market growth[1].

Competition from Biosimilars

The introduction of generic versions and biosimilars of SUTENT is enhancing accessibility and affordability but also increases competition. This competition may pressure pricing strategies and impact the market dynamics[1].

Financial Trajectory

Historical Performance

In 2007, Pfizer reported significant revenue growth from SUTENT, with revenues increasing by 75% in the fourth quarter compared to the previous year, reaching $182 million. For the full year, SUTENT revenues were $581 million, a 166% increase from 2006[2].

Current Market Size and Forecast

The global sunitinib malate market, which includes SUTENT, was valued at USD 107.6 million in 2022 and is expected to reach USD 328.2 million by 2032, growing at a CAGR of 11.8% during the forecast period. North America currently dominates the market, driven by high customer incomes and comprehensive health insurance coverage[4].

Regional Performance

North America, particularly the United States, leads the SUTENT market in terms of size and growth. Europe, especially Germany and the U.K., also has a substantial market share due to advanced healthcare systems and robust regulatory frameworks. The Asia-Pacific region, including China and India, is emerging rapidly due to increasing cancer prevalence and improving healthcare access[1][4].

Future Outlook

Growth Projections

The SUTENT market is projected to exhibit steady long-term growth, driven by increasing cancer prevalence and the rising demand for targeted therapies. The market is expected to grow at a CAGR of 6.00% to 11.8% during the forecast period, depending on the source and specific market segment[1][4].

Emerging Opportunities

Emerging opportunities include expanding indications for SUTENT in other cancer types, the potential for personalized medicine approaches to improve treatment effectiveness, and collaborations between pharmaceutical companies and biotech firms to foster innovative drug development. These factors position the SUTENT market for sustained growth despite ongoing challenges[1].

Regulatory and Competitive Landscape

Stakeholders must focus on collaborative research and development initiatives to enhance drug efficacy and explore combination therapies. Addressing regulatory challenges and maintaining robust patient access programs will be crucial for sustained success in this evolving environment. The market will also need to navigate the impact of novel immunotherapies and personalized medicine, which could significantly reshape the treatment landscape[1].

Key Takeaways

• The SUTENT market is driven by the increasing incidence of cancer and the demand for targeted therapies.
• Advancements in treatment protocols and patient management are enhancing market growth.
• High costs, drug resistance, and regulatory challenges are significant restraints.
• The market is expected to grow steadily, with North America and Europe leading and the Asia-Pacific region emerging rapidly.
• Emerging opportunities include expanding indications, personalized medicine, and collaborative research initiatives.

FAQs

Q: What is SUTENT primarily used for? A: SUTENT, or sunitinib, is primarily used for treating certain types of cancer, including renal cell carcinoma and gastrointestinal stromal tumors.

Q: What are the main drivers of the SUTENT market? A: The main drivers include the increasing incidence of cancer, advancements in treatment protocols, and growing demand for targeted therapies.

Q: What are the significant challenges facing the SUTENT market? A: High costs, drug resistance, and stringent regulatory requirements are significant challenges.

Q: Which regions dominate the SUTENT market? A: North America, particularly the United States, and Europe are the dominant regions, with the Asia-Pacific region emerging rapidly.

Q: What is the projected growth rate of the SUTENT market? A: The market is projected to grow at a CAGR of 6.00% to 11.8% during the forecast period, depending on the source and specific market segment.

Sources

1. Detailed Analysis of Sunitinib Drug Market Growth - OpenPR
2. Pfizer Reports Fourth-Quarter and Full-Year 2007 Results and 2008 Financial Guidance - Pfizer
3. Sunitinib Malate Cas 341031 54 7 Market Size And Forecast - Market Research Intellect
4. Sunitinib Malate Market Size, 2032 Forecast Report - The Brainy Insights
5. PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES 2023 FINANCIAL GUIDANCE - Pfizer