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Last Updated: December 22, 2024

SUNITINIB MALATE Drug Patent Profile


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When do Sunitinib Malate patents expire, and when can generic versions of Sunitinib Malate launch?

Sunitinib Malate is a drug marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Wanbang Biopharms. and is included in seven NDAs.

The generic ingredient in SUNITINIB MALATE 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 Sunitinib Malate

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

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Drug patent expirations by year for SUNITINIB MALATE
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Recent Clinical Trials for SUNITINIB MALATE

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

SponsorPhase
ExelixisPhase 3
VU University Medical CenterPhase 2/Phase 3
Graybug VisionPhase 2

See all SUNITINIB MALATE clinical trials

Pharmacology for SUNITINIB MALATE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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
Wanbang Biopharms SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 218012-004 Aug 21, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843-001 Apr 11, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213914-002 Aug 16, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213803-004 Nov 30, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Eugia Pharma SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 218615-003 Mar 14, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843-004 Apr 11, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 201275-004 Dec 6, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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]

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