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, Fosun Wanbang, MSN, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Cppi Cv, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for SUNITINIB MALATE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	175
Patent Applications:	6,493
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
Fosun Wanbang	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218012-004	Aug 21, 2023	AB	RX	No	No
Mylan	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	201275-001	Dec 6, 2021	AB	RX	No	No
Mylan	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	201275-002	Dec 6, 2021	AB	RX	No	No

Market Dynamics and Financial Trajectory for SUNITINIB MALATE

Last updated: November 14, 2025

---

Introduction

Sunitinib Malate, marketed as Sutent among other brand names, is an oral multi-targeted receptor tyrosine kinase inhibitor primarily used to treat various cancers such as renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and other malignancies. Since its FDA approval in 2006, Sunitinib Malate's market presence and financial performance have been influenced by an intricate web of scientific, commercial, regulatory, and competitive factors. This analysis provides a comprehensive overview of its current market dynamics and financial outlook, essential for stakeholders considering investment or strategic positioning.

---

Pharmacological Profile and Therapeutic Indications

Sunitinib inhibits multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs), and others involved in tumor growth and angiogenesis. Its mechanism underpins its efficacy across several oncological indications, notably:

• Renal Cell Carcinoma (RCC): First-line treatment for advanced RCC.
• Gastrointestinal Stromal Tumors (GIST): Second-line therapy post-imatinib failure.
• Other indications: Pancreatic neuroendocrine tumors, hepatocellular carcinoma, among others (though these are less prevalent).

The versatility of Sunitinib’s mechanism expands its potential market, yet also subjects it to competitive pressures within its indications.

---

Market Dynamics

1. Competitive Landscape

Sunitinib faces formidable competition from both targeted therapies and immunotherapies. Key competitors include:

• Axitinib and Pazopanib: Other VEGFR inhibitors approved for RCC.
• Immunotherapy agents: Nivolumab, pembrolizumab, and combination therapies are increasingly replacing tyrosine kinase inhibitors (TKIs) in various indications.
• Emerging targeted drugs: Tucatinib, cabozantinib, and others continue to erode market share.

The rise of immune checkpoint inhibitors has notably shifted treatment paradigms, reducing the dominance of TKIs like Sunitinib in some indications.

2. Regulatory and Clinical Developments

While Sunitinib remains approved and utilized, several factors influence its market dynamics:

• Off-label use: Expansion into lesser-approved indications may temporarily boost sales.
• Companion diagnostics: Increased testing for predictive biomarkers might improve patient stratification, optimizing treatment efficacy.
• Label updates and post-marketing studies: Data on long-term safety and efficacy can impact prescribing behaviors.

3. Patent and Market Exclusivity

Sunitinib’s first patent expiration is approaching or has occurred in key markets, potentially inviting generic competition. Generic versions can significantly reduce drug prices and impact profit margins, a common trend in oncology therapeutics.

4. Pricing and Reimbursement Climate

Pricing strategies heavily influence revenue. High-cost oncology drugs face pressure from:

• Health authorities seeking cost-effective treatment options.
• Negotiations with payers and insurance providers.
• Cost-containment pressures in healthcare systems worldwide.

In some regions, Sunitinib’s patent expiry has already precipitated generic entry, affecting its premium pricing potential.

---

Financial Trajectory

1. Revenue Trends

Historically, Sunitinib has generated peak annual revenues in excess of $1 billion globally [1]. However, revenues are subject to decline due to:

• Patent expirations leading to generic competition.
• Market share erosion from emerging therapies.
• Geographic variations in adoption and reimbursement policies.

Recent financial disclosures indicate a gradual decline in sales in matured markets, correlating with increased generic availability.

2. Impact of Patent Expirations

The imminent patent cliff constrains future revenue growth. For example, in the U.S., the primary patent protection has expired or is expiring, prompting strong generic entry. This trend typically results in significant price reductions and volume increases, partially offsetting revenue declines. Global markets, especially in emerging economies, present growth opportunities due to increasing cancer incidence and expanding healthcare access.

3. R&D Investment and Pipeline Development

Continued investment in clinical development—either for new indications, combination regimens, or next-generation formulations—can extend Sunitinib's lifecycle. However, the attrition rate in oncology R&D necessitates cautious optimism. Partnerships with biotech firms and licensing agreements could bolster pipeline prospects and sustain revenue streams.

4. Partner and Licensee Arrangements

Manufacturers often rely on licensing agreements with regional partners to maintain market presence post-patent. These arrangements can provide revenue through royalties, though margins diminish as generic competition escalates.

---

Market Opportunities and Challenges

Opportunities

• Expansion into emerging markets with rising cancer rates.
• Development of combination therapies with immunotherapies.
• Real-world evidence demonstrating cost-effectiveness could bolster reimbursement.

Challenges

• Growing competition from immuno-oncology agents.
• Patent expiry leading to generic erosion.
• Price sensitivity and healthcare policy shifts favoring biosimilars and generics.
• Limited pipeline for new indications compared to other targeted therapies.

---

Conclusion: Strategic Outlook

Sunitinib Malate's market trajectory reflects a transitioning phase from a pioneering targeted agent to a commoditized generic product in some regions. Its future viability hinges on strategic positioning, including:

• Diversification through combination regimens.
• Entry into less saturated markets.
• Ongoing clinical research to broaden indications.
• Cost management in face of pricing pressures.

Investors and stakeholders must weigh patent expiration timelines against emerging therapies and regional market dynamics to optimize longevity and profitability.

---

Key Takeaways

• Market erosion due to patent expiry critically influences Sunitinib’s future revenue potential.
• Emerging immunotherapies are challenging traditional TKI treatment dominance, requiring adaptation.
• Generic competition is inevitable post-patent and significantly impacts pricing strategies.
• Regional expansion in emerging economies offers growth avenues amid global competition.
• Pipeline development and combination strategies could sustain relevance in an evolving oncology landscape.

---

FAQs

Q1: How soon will generic versions of Sunitinib enter the market?
A: The primary patent in major jurisdictions has expired or will shortly, leading to imminent entry of generic competitors, with some markets experiencing generics already available.

Q2: Can Sunitinib be used beyond its approved indications?
A: Off-label use exists, but widespread adoption depends on emerging clinical evidence and regulatory approvals.

Q3: How does immunotherapy impact Sunitinib’s market position?
A: The rise of immune checkpoint inhibitors has shifted treatment algorithms, often replacing TKIs like Sunitinib as first-line therapy in certain indications.

Q4: What strategies can extend Sunitinib’s market life?
A: Developing combination therapies, exploring new indications, and entering underserved markets can provide revenue stability.

Q5: How does pricing influence Sunitinib’s competitiveness?
A: Generic entry leads to significant price reductions, influencing overall revenue, demanding adaptive pricing and reimbursement strategies.

---

References

[1] Market reports and company disclosures, 2022.