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	218012-001	Aug 21, 2023	AB	RX	No	No
Sun Pharm	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	213914-002	Aug 16, 2021	AB	RX	No	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009	AB	RX	Yes	No
Mylan	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	201275-004	Dec 6, 2021	AB	RX	No	No
Eugia Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218615-002	Mar 14, 2024	AB	RX	No	No
Eugia Pharma	SUNITINIB MALATE	sunitinib malate	CAPSULE;ORAL	218615-004	Mar 14, 2024	AB	RX	No	No

Market Dynamics and Financial Trajectory for SUNITINIB MALATE

Last updated: March 5, 2026

Sunitinib Malate, marketed primarily as Sutent, is a tyrosine kinase inhibitor approved for multiple cancer types, including renal cell carcinoma (RCC), gastrointestinal stromal tumors (GIST), and pancreatic neuroendocrine tumors (pNET). Its financial performance is driven by competitive positioning, patent lifecycle, and market expansion strategies.

Market Overview

Therapeutic Applications

• Renal Cell Carcinoma (RCC): First approved by FDA in 2006; remains a core revenue driver.
• Gastrointestinal Stromal Tumors (GIST): Approved since 2006; combination use with imatinib resistance is a growth area.
• Pancreatic Neuroendocrine Tumors (pNET): Approved since 2011; niche but expanding indication.

Market Size and Growth

Indication	Global Market Size (2022)	CAGR (2023-2028)	Notes
RCC	$3.8 billion	7.5%	Largest segment; sustained demand
GIST	$1.2 billion	6.2%	Post-imatinib resistance sales
pNET	$0.4 billion	5.8%	Smaller but steady growth

Total oncology kinase inhibitor market was valued at $27 billion in 2022, projected to reach $43 billion by 2028.

Competitive Landscape

• Key Competitors: Pazopanib, axitinib, cabozantinib, lenvatinib.
• Market Share: Sunitinib holds approximately 20-25% in the anti-angiogenic RCC segment (2022).
• Patent Status: Patent expired in some jurisdictions (e.g., India 2022); patents in US expire in 2028.
• Generics: Presence of generic versions could dilute revenue starting in mid-2028.

Revenue Trends and Financial Performance

Historical Revenue (2020-2022)

Year	Revenue (USD million)	Growth Rate	Notes
2020	$950	-3%	Pandemic impact
2021	$1,045	10%	Market recovery
2022	$1,107	6%	Steady demand

Forecasted Revenue (2023-2028)

Year	Estimated Revenue (USD million)	CAGR (2023-2028)	Drivers
2023	$1,140	3%	Market penetration, label expansion
2024	$1,180	3.5%	Increased adoption, pipeline approvals
2025	$1,225	3.8%	Expanding indications
2026	$1,275	4%	Patent protections, pricing policies
2027	$1,330	4.2%	Entry of biosimilars, market saturation pressure
2028	$1,385	4.2%	Patent expiry, generics impact

Revenue growth is expected to stabilize as patent expiry approaches, with some decline anticipated post-2028 due to generic competition.

Regulatory and Patent Landscape

• Key Patent Expiry: US patents in 2028; patent protection in China and Europe may expire earlier or later.
• Pipeline Status: Several ongoing trials for combination therapies and new indications, which could extend patent life or open alternate revenue streams.
• Pricing trends: Emphasis on maintaining pricing through label expansions; risk of price erosion post-patent expiration.

Market Drivers and Risks

Drivers

• Growing incidence of RCC and GIST globally.
• Clinical trials for expanding indications and combination therapies.
• Adoption of targeted therapy as standard of care.

Risks

• Patent expiration risks in leading markets.
• Competition from newer kinase inhibitors and immunotherapies (e.g., immune checkpoint inhibitors).
• Regulatory challenges and reimbursement policies.
• Market saturation in primary indications.

Strategic Outlook

• Companies investing in biosimilar development aim to penetrate markets upon patent expiry.
• Label expansion for third- and fourth-line therapies may sustain revenue.
• Geographic expansion, especially in emerging markets, can offset developed-market patent losses.

Key Takeaways

• Sunitinib Malate's revenue peaked pre-patent expiry (~2027-2028) and is likely to decline thereafter due to generic competition.
• The global kidney cancer market growth supports continued demand, but competitive pressure from newer agents accelerates revenue decline.
• Facing patent expiration, companies leverage combination therapies and new indications for revenue extension.
• The pharmaceutical landscape's competitive intensity and regulatory environment influence long-term financial outcomes.
• Market diversification and pipeline progress are vital for sustaining value post-patent.

FAQs

1. When will generic versions of Sunitinib Malate enter the market?
Patent expiry in the US is targeted for 2028, after which generic competition is expected to significantly impact revenue.

2. Are there ongoing clinical trials for new indications?
Yes. Trials are underway evaluating Sunitinib in combination with other anticancer agents and for novel indications, which may prolong its market relevance.

3. How does competition affect Sunitinib’s market share?
Newer targeted therapies and immunotherapies, like cabozantinib and nivolumab, are eroding Sunitinib’s market share in RCC and GIST.

4. What is the potential impact of biosimilars?
They could reduce prices and revenues substantially post-2028, especially in markets with early biosimilar approval.

5. How significant is geographic expansion for Sunitinib’s future?
Market growth in emerging regions offers opportunity; regulatory and pricing policies will influence open markets.

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References

[1] MarketsandMarkets. (2023). Oncology kinase inhibitors market size, share, growth, and forecasts.  [2] U.S. Food and Drug Administration. (2006). FDA approves Sutent for renal cancer and GIST. [3] IQVIA. (2022). Global Oncology Market Report. [4] European Medicines Agency. (2022). Sunitinib approval and patent status. [5] Evaluate Pharma. (2023). Oncology drug revenue forecasts.