SUNITINIB MALATE - Generic Drug Details

What are the generic drug sources for sunitinib malate and what is the scope of patent protection?

Sunitinib malate is the generic ingredient in two branded drugs marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, Wanbang Biopharms, and Cppi Cv, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for sunitinib malate. Ten suppliers are listed for this compound.

Summary for SUNITINIB MALATE

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	175
Patent Applications:	2,379
Drug Prices:	Drug price trends for SUNITINIB MALATE
What excipients (inactive ingredients) are in SUNITINIB MALATE?	SUNITINIB MALATE excipients list
DailyMed Link:	SUNITINIB MALATE at DailyMed

See drug prices for SUNITINIB MALATE

Recent Clinical Trials for SUNITINIB MALATE

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

Sponsor	Phase
Exelixis	Phase 3
VU University Medical Center	Phase 2/Phase 3
Graybug Vision	Phase 2

See all SUNITINIB MALATE clinical trials

Pharmacology for SUNITINIB MALATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SUNITINIB MALATE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for SUNITINIB MALATE

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 SUNITINIB MALATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218615-004	Mar 14, 2024	AB	RX	No	No
Teva Pharms Usa	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	213803-003	Nov 30, 2021	AB	RX	No	No
Natco Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218024-002	Oct 24, 2023	AB	RX	No	No
Wanbang Biopharms	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218012-004	Aug 21, 2023	AB	RX	No	No

SUNITINIB MALATE Market Analysis and Financial Projection Experimental

Sunitinib Malate Market Dynamics and Financial Trajectory

Market Overview

The global Sunitinib Malate market is poised for significant growth, driven by its efficacy in treating various types of cancer. Here are the key dynamics and financial projections for this market.

Market Size and Growth

The Sunitinib Malate market is expected to expand substantially, with a projected market size of around USD 378.0 Million by 2033, up from USD 120.6 Million in 2023. This growth is anticipated at a Compound Annual Growth Rate (CAGR) of 12.1% during the forecast period from 2024 to 2033[1][3].

Application Analysis

Sunitinib malate is primarily used in the treatment of several types of cancer, including:

Pancreatic Neuroendocrine Tumors

This segment occupies a significant 41.3% of the market share as of 2023. The drug's effectiveness in inhibiting cell proliferation and angiogenesis makes it a crucial treatment option for these tumors[1].

Kidney Cancer

Sunitinib malate is also approved for the treatment of kidney cancer, contributing to its market growth.

Gastrointestinal Stromal Tumors

Another key application area, this segment further diversifies the drug's therapeutic uses[4].

Regional Analysis

North America

This region dominates the market, accounting for a substantial 40% share and generating USD 48.2 Million in market revenue as of 2023. The high incidence of pancreatic cancer and extensive health insurance coverage in the United States are significant drivers of this growth[1].

Emerging Markets

There is a notable opportunity for expansion into emerging markets, where the cancer burden is increasing and healthcare infrastructure is improving. These regions present untapped potential for market players to introduce Sunitinib Malate and meet unmet medical needs[1].

Drivers of Growth

Increasing Prevalence of Cancer

The rising cases of gastrointestinal disorders, particularly pancreatic cancer, are driving the demand for Sunitinib Malate. The expanding geriatric population also contributes to this trend[4].

Precision Medicine

Sunitinib Malate aligns with the trend towards personalized and targeted therapies, enhancing its significance in the era of precision medicine. This targeted approach improves treatment outcomes and patient compliance[1].

R&D and Clinical Trials

Ongoing clinical trials and the identification of new indications are expected to expand the therapeutic areas for Sunitinib Malate. Novel formulations and combination therapies are also being developed, further increasing the drug's appeal across clinical settings[1][4].

Challenges and Restraints

Supply Chain Disruptions

The COVID-19 pandemic posed significant challenges, including supply chain disruptions that affected product availability and market growth. However, these challenges are being mitigated as the global healthcare system recovers[4].

Regulatory and Economic Factors

Changes in regulatory environments and economic conditions can impact market dynamics. For instance, fluctuations in healthcare policies and insurance coverage can affect the affordability and accessibility of cancer treatments[5].

Financial Trajectory

Revenue Projections

The market is expected to grow from USD 120.6 Million in 2023 to USD 378.0 Million by 2033, with a CAGR of 12.1%. This significant growth is driven by increasing demand, expanding applications, and strategic collaborations[1][3].

Strategic Collaborations and Partnerships

The market has seen an increasing trend of strategic collaborations and partnerships, which foster innovation by helping to develop novel formulations and combination therapies. These collaborations are crucial for driving market growth and expanding the drug's therapeutic potential[1].

Market Opportunities

Expansion into Emerging Markets

There is a substantial opportunity for market expansion into emerging markets where the cancer burden is growing rapidly. Increasing healthcare infrastructure and awareness in these regions present untapped potential for market players[1].

Pipeline Development

The ongoing identification of new indications and the development of novel formulations or combination therapies offer immense opportunities for market growth. Clinical trials and regulatory approvals for new therapeutic areas will further expand the market potential of Sunitinib Malate[1][4].

Key Takeaways

• Market Size: Expected to reach USD 378.0 Million by 2033 from USD 120.6 Million in 2023.
• Market Growth: Growing at a CAGR of 12.1% during the forecast period from 2024 to 2033.
• Application Analysis: Pancreatic Neuroendocrine Tumors occupy 41.3% of the market share.
• Regional Analysis: North America dominates with a 40% market share.
• Precision Medicine: Aligns with the trend towards personalized and targeted therapies.
• Strategic Collaborations: Increasing trend of collaborations to develop novel formulations and combination therapies.

FAQs

What is the expected market size of Sunitinib Malate by 2033?

The global Sunitinib Malate market is expected to be worth around USD 378.0 Million by 2033[1][3].

What is the CAGR of the Sunitinib Malate market from 2024 to 2033?

The market is growing at a CAGR of 12.1% during the forecast period from 2024 to 2033[1][3].

Which region dominates the Sunitinib Malate market?

North America dominates the market, accounting for a substantial 40% share and generating USD 48.2 Million in market revenue as of 2023[1].

What are the primary applications of Sunitinib Malate?

The primary applications include the treatment of pancreatic neuroendocrine tumors, kidney cancer, and gastrointestinal stromal tumors[1][4].

What are the key drivers of growth for the Sunitinib Malate market?

The increasing prevalence of cancer, particularly pancreatic cancer, and the trend towards precision medicine are significant drivers. Additionally, ongoing R&D and clinical trials are expanding the drug's therapeutic potential[1][4].

Sources

1. Market.us: Sunitinib Malate Market Size, Share, Outlook | CAGR of 12.1% [https://market.us/report/sunitinib-malate-market/]
2. Market Research Intellect: Sunitinib Malate Cas 341031 54 7 Market Size And Forecast [https://www.marketresearchintellect.com/product/sunitinib-malate-cas-341031-54-7-market-size-and-forecast/]
3. PharmiWeb: Sunitinib Malate Market Forecasted to Reach USD 378.0 Million by 2033, Driven by 12.1% CAGR [https://www.pharmiweb.com/press-release/2024-04-29/sunitinib-malate-market-forecasted-to-reach-usd-3780-million-by-2033-driven-by-121-cagr]
4. Stratview Research: Sunitinib Malate Market | Market Size, Share & Forecast Analysis [https://www.stratviewresearch.com/2478/Sunitinib-Malate-Market.html]
5. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Financial Guidance [https://s28.q4cdn.com/781576035/files/doc_financials/2023/q4/Q4-2023-PFE-Earnings-Release.pdf]