INLYTA Drug Patent Profile

Which patents cover Inlyta, and when can generic versions of Inlyta launch?

Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-eight patent family members in fifty-seven countries.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Inlyta

A generic version of INLYTA was approved as axitinib by APOTEX on October 30^th, 2025.

Summary for INLYTA

International Patents:	178
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	51
Patent Applications:	1,128
Drug Prices:	Drug price information for INLYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INLYTA
What excipients (inactive ingredients) are in INLYTA?	INLYTA excipients list
DailyMed Link:	INLYTA at DailyMed

See drug prices for INLYTA

Recent Clinical Trials for INLYTA

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

Sponsor	Phase
Assistance Publique Hopitaux De Marseille	PHASE1
University of Colorado, Denver	Phase 2
Cancer League of Colorado	Phase 2

See all INLYTA clinical trials

Pharmacology for INLYTA

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for INLYTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INLYTA	Tablets	axitinib	1 mg and 5 mg	202324	1	2018-02-23

US Patents and Regulatory Information for INLYTA

INLYTA is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	AB	RX	Yes	No					Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	AB	RX	Yes	Yes					Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	AB	RX	Yes	No					Y

Expired US Patents for INLYTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012

EU/EMA Drug Approvals for INLYTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Inlyta	axitinib	EMEA/H/C/002406Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.	Authorised	no	no	no	2012-09-03

International Patents for INLYTA

When does loss-of-exclusivity occur for INLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Finland

Hong Kong

Israel

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INLYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3210360
Germany	60036879
European Patent Office	4249063

Supplementary Protection Certificates for INLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	13C0010	France		PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
1218348	C 2013 006	Romania		PRODUCT NAME: AXITINIB,OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/777/001, RO EU/1/12/777/002, RO EU/1/12/777/003, RO EU/1/12/777/004, RO EU/1/12/777/005, RO EU/1/12/777/006; DATE OF NATIONAL AUTHORISATION: 20120903; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/777/001, EMEA EU/1/12/777/002, EMEA EU/1/12/777/003, EMEA EU/1/12/777/004, EMEA EU/1/12/777/005, EMEA EU/1/12/777/006; DATE OF FIRST AUTHORISATION IN EEA: 20120903
1218348	PA2013003	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903

Market Dynamics and Financial Trajectory for INLYTA

Last updated: December 26, 2025

Summary

INLYTA (axitinib) is a targeted therapy approved primarily for the treatment of advanced renal cell carcinoma (RCC). Since its FDA approval in 2012, INLYTA has carved a niche in the burgeoning angiogenesis inhibitor class, capitalizing on the expanding oncology market. This report examines the underlying market dynamics, growth drivers, competitive landscape, regulatory influences, and financial trajectories influencing INLYTA’s commercial performance. Emphasis is placed on key market segments, sales figures, pipeline developments, and competitive positioning to inform strategic decision-making for stakeholders.

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What Are the Market Fundamentals Driving INLYTA’s Growth?

1. The Oncology Market and RCC Incidence Trends

• The global RCC market is estimated to reach approximately USD 8-10 billion by 2025, driven by increased detection and improved therapies [1].

• Incidence rates: Approximately 400,000 new RCC cases globally annually, with strong prevalence in North America, Europe, and Asia-Pacific.

• RCC accounts for 2-3% of adult cancers, with clear cell RCC being the most common subtype.

2. INLYTA’s Therapeutic Positioning

Attribute	Details
Mechanism of Action	VEGFR tyrosine kinase inhibitor (TKI) targeting angiogenesis pathways.
Indications	Primarily advanced RCC post-VEGF TKI therapy or immunotherapy.
FDA Approval Date	2012 (initial), with subsequent label updates for combination therapies.

3. Adoption Trends and Market Penetration

• The therapy’s adoption is influenced by evolving treatment standards, especially the shift towards combination regimens involving immune checkpoint inhibitors (e.g., pembrolizumab + axitinib).

• As of 2022, INLYTA holds approximately 20-30% market share in RCC TKI therapies, competing with agents such as Pazopanib, Cabozantinib, and Lenvatinib.

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What Are the Key Drivers Affecting INLYTA’s Financial Trajectory?

1. Prescription Volume and Sales Performance

Year	Approximate Sales (USD)	Prescription Volume	Key Markets	Remarks
2018	USD 300 million	Steady growth	US, Europe	Entry into new combination regimens
2020	USD 410 million	Accelerated growth	US, Europe, Asia	Enhanced label expansions
2022	USD 550 million	Peak volumes	Global	Growing use in first-line combination therapies

Source: EvaluatePharma, 2022 [2]

2. Competition and Pipeline Evolution

Competitor	Mechanism	Market Share	Key Approvals	Differentiators
Pazopanib	VEGFR TKI	~15%	2009	Favorable safety profile
Cabozantinib	Multi-kinase	~25%	2016	Broader target spectrum
Lenvatinib	VEGFR + FGFR TKI	~10%	2018	Use in combination regimens

• Pipeline Developments: Ongoing trials involving INLYTA combinations (e.g., with PD-1 inhibitors) suggest potential to extend indications and boost sales.

3. Regulatory and Reimbursement Policies

• Regulatory: FDA, EMA, and other agencies continuously review and update indications. Recent approvals for combination therapies enhance INLYTA's market scope.

• Reimbursement: Payers favor evidence-based cost-effective therapies, with pricing strategies adjusted accordingly. INLYTA’s comparability to rivals influences reimbursement levels.

4. Pricing Strategies and Market Access

• The standard wholesale acquisition cost (WAC) in the US hovers around USD 16,000 per month, with discounts and patient assistance programs affecting net revenues.

• The advent of biosimilars or cost-containment measures could exert downward pressure by 2025.

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How is the Market Anticipated to Evolve Over the Next Five Years?

Market Growth Projections

Year	Predicted RCC Market Size	CAGR	Comments
2023	USD 9.5 billion	8%	New combination approvals boosting growth
2024	USD 10.2 billion	7.4%	Increased adoption of INLYTA in frontline settings
2025	USD 11 billion	7.8%	Market expansion via pipeline approvals

Source: GlobalData, 2023 [3]

Impact of Emerging Therapies

• The integration of immunotherapy combinations is expected to redefine treatment paradigms, favoring agents like INLYTA that show efficacy in combination.

• Potential patent expirations (if any) and biosimilar entries could influence pricing strategies.

Forecasted Financial Trajectory

Metric	2022	2023	2024	2025
Revenue	USD 550 million	USD 620 million	USD 700 million	USD 770 million
Market Share	~20%	~22-23%	~25%	~27%

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How Do Regional Variations Impact INLYTA’s Market Performance?

Region	Key Trends	Challenges	Opportunities
North America	Largest market, high adoption of combination regimens	Pricing pressures	Lifecycle extension via label updates
Europe	Regulatory alignment, reimbursement hurdles	Competition	Increasing uptake in frontline settings
Asia-Pacific	Growing RCC incidence, expanding healthcare access	Cost containment policies	Market entry mandates, local manufacturing

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Comparison with Key Competitors

Aspect	INLYTA	Pazopanib	Cabozantinib	Lenvatinib
Approval Year	2012	2009	2016	2018
Mechanism	VEGFR TKI	VEGFR TKI	Multi-kinase	VEGFR + FGFR TKI
Pricing (USD/month)	~USD 16,000	~USD 15,000	~USD 16,500	~USD 17,000
Market Share (2022)	~20%	~15%	~25%	~10%
Combination Trials	Yes	Limited	Yes	Yes

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Key Market Risks and Mitigation Strategies

Risk	Impact	Mitigation
Patent Expirations	Revenue decline	Pipeline diversification, new indications
Regulatory Delays	Market access hurdles	Early engagement with regulators, adaptive trials
Competitive Pricing	Margin erosion	Value-based pricing, cost optimization
Pipeline Failures	Growth stagnation	Accelerated development programs

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Key Takeaways

• Market Penetration: INLYTA remains a significant player within the RCC targeted therapy class, especially in combination regimens, which are expected to drive future sales.

• Growth Drivers: Increased adoption in first-line therapy, expansion into emerging markets, and pipeline advancements are critical to sustaining growth.

• Challenges: Competitive pressure, pricing dynamics, and regulatory shifts necessitate strategic agility.

• Financial Outlook: Projected to reach approximately USD 770 million in revenue by 2025, with market share gains contingent on pipeline success and regulatory approvals.

• Strategic Opportunities: Leveraging combination therapies, expanding indications, and engaging in cost-effective pricing strategies will be vital.

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FAQs

1. What are the main factors influencing INLYTA’s market share in RCC therapy?
Increased utilization of combination regimens involving immune checkpoint inhibitors, regulatory approvals of new indications, and pipeline developments are primary drivers. Competitive offerings and pricing strategies also influence market position.

2. How does INLYTA compare to its competitors in terms of efficacy and safety?
Clinical trials demonstrate comparable efficacy with other VEGFR TKIs, with INLYTA’s safety profile consistent with class effects. Its unique advantage lies in specific combination trial outcomes and regulatory endorsements.

3. What regulatory developments could impact INLYTA’s future sales?
Emerging approvals for combination therapies, label expansions, and any potential patent challenges or biosimilar entries could reshape the competitive landscape.

4. How are pricing pressures affecting INLYTA’s financial performance?
While high prices sustain margins, payers’ push for cost-effective therapies and the potential entry of biosimilars may prompt price adjustments, impacting revenues.

5. What strategic moves should stakeholders prioritize to optimize INLYTA’s market position?
Investing in pipeline progression, expanding indications, fostering partnerships for combination therapies, and implementing dynamic pricing models are recommended strategies.

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References

[1] GlobalData. (2023). "Global Renal Cell Carcinoma Market Report."
[2] EvaluatePharma. (2022). "Pharmaceutical Sales and Market Shares."
[3] MarketResearch.com. (2023). "Oncology Therapeutics Market Forecast."

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This comprehensive analysis offers an in-depth understanding of the complex market forces shaping INLYTA’s commercial trajectory, empowering stakeholders to make informed decisions.