INLYTA Drug Patent Profile

When do Inlyta patents expire, 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
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	AB	RX	Yes	Yes					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	202324-002	Jan 27, 2012
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	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
Norway	2013004
Costa Rica	10194	COMPUESTOS DE INDAZOLE Y COMPOSICIONES FAMACÉUTICAS PARA LA INHIBICIÓN DE LA PROTEÍNA CINASA Y MÉTODOS PARA SU USO (DIVISIONAL EXP. 6517)
Hong Kong	1085470
Poland	3498734

Supplementary Protection Certificates for INLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	92154	Luxembourg		PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348	122013000016	Germany		PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348	C300576	Netherlands		PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 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

Market Dynamics and Financial Trajectory for Inlyta (Axitinib)

Last updated: July 27, 2025

Introduction

Inlyta (axitinib) is an oral tyrosine kinase inhibitor (TKI) developed by Pfizer, primarily approved for the treatment of advanced renal cell carcinoma (RCC). Since its initial approval in 2012, Inlyta has solidified its position within the targeted oncology market, driven by evolving treatment paradigms, increasing global cancer prevalence, and strategic collaborations. The dynamics of its market and financial trajectory are shaped by multiple factors, including competitive landscape shifts, regulatory developments, reimbursement policies, and technological advancements.

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Market Overview

Global Renal Cell Carcinoma Treatment Market

The global RCC market is projected to grow at a compound annual growth rate (CAGR) of approximately 7-8% through 2028, driven by rising incidence, aging populations, and a significant shift toward targeted therapies over traditional chemotherapies [1]. The global burden of RCC is estimated at over 430,000 new cases annually, with higher prevalence in North America and Europe, and rising incidence in Asia-Pacific regions due to increased screening and lifestyle factors [2].

Inlyta’s Position

Inlyta competes in the subset of targeted therapies for RCC, which includes agents like sunitinib, cabozantinib, lenvatinib, and pazopanib. It is primarily indicated for patients with advanced or metastatic RCC following prior systemic therapy. Its strategic positioning benefits from Pfizer's established sales infrastructure and clinical evidence supporting its efficacy.

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Market Dynamics

Driving Factors

1. Clinical Evidence and Efficacy

Inlyta’s role in the treatment landscape is robustly supported by pivotal trials such as AXIS, which demonstrated its superior progression-free survival (PFS) compared to sorafenib, especially in second-line settings [3]. Continued research and real-world data reinforce its efficacy, enhancing physician confidence and adoption.

2. Regulatory Approvals and Expansions

Initial approval by the FDA in 2012 was followed by regulatory clearances across multiple regions, including the European Medicines Agency (EMA). Recently, efforts to expand indications—such as combination therapies with checkpoint inhibitors—have received regulatory attention, potentially broadening the drug’s market.

3. Competitive Landscape

The competitive landscape remains intense. While Inlyta maintains a solid market share, it faces substantial competition from other TKIs and immune-oncology (I/O) combination therapies. The emergence of drugs like pembrolizumab plus axitinib combination (Keytruda + Inlyta) has signaled a paradigm shift, offering improved efficacy and tolerability in first-line settings [4].

4. Technological and Treatment Paradigm Shifts

The adoption of combination regimens integrating immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) with TKIs is redefining treatment algorithms, potentially impacting Inlyta's monotherapy sales. However, Pfizer’s participation by developing and marketing combination strategies helps maintain its relevance.

5. Geographical Market Expansion

Emerging markets, particularly in Asia-Pacific, show promising growth potential due to increasing RCC awareness, improved healthcare infrastructure, and rising healthcare spending. Pfizer’s strategic expansion efforts are tailored toward these fast-growing regions.

Challenges

• Pricing and Reimbursement Policies: Stringent cost-effectiveness evaluations and payor restrictions in various markets can limit access and sales.
• Generic and Biosimilar Competition: Although no biosimilar exists for axitinib yet, patent expirations or regulatory challenges could threaten future exclusivity.
• Shift Toward Immunotherapies: The innovation trajectory favors immune-oncology combinations, possibly diminishing monotherapy sales of Inlyta.

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Financial Trajectory

Historical Revenue Performance

Since its launch, Inlyta has demonstrated steady but moderate revenue growth influenced mainly by its second-line indication. Pfizer’s oncology segment reported Inlyta's contribution as part of its broader portfolio, with global sales reaching approximately $500 million in 2022—a notable achievement given market competition and patent protections [5].

Revenue Drivers

• Efficacy in second-line RCC: Providing durable responses with manageable safety profiles solidifies repeat and off-label prescribing.
• Combination Therapy Potential: Pfizer’s ongoing trials combining Inlyta with immune checkpoint inhibitors aim to extend revenue streams into first-line indications and broader oncology markets.
• Regional Growth: Increased adoption in Asia-Pacific and emerging markets is expected to accelerate sales. For instance, China’s expanding cancer treatment access offers high growth potential, driven by localized regulatory approval and partnerships.

Forecasting Future Revenue Trends

Based on market analyses, Inlyta’s global sales could reach $1 billion annually by 2028 if current growth rates persist and expansion strategies are successful. This projection assumes:

• Continued efficacy and safety profile support
• Expansion into first-line RCC indications through combination therapy approvals
• Sustained market penetration in emerging economies
• Competitive positioning against newer therapies

Key Risks and Opportunities

• Patent Expirations: Risk of generic entry post-patent expiry could significantly erode revenues unless new formulations, combinations, or indications expand the product lifecycle.
• Pipeline Developments: Pfizer’s ongoing trials involving Inlyta in combination regimes and other tumor types (e.g., hepatocellular carcinoma) could unlock new revenue streams.
• Pricing Pressures: Healthcare payors’ resistance to high-cost targeted therapies may suppress revenue growth if affordability concerns increase globally.

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Market Outlook and Strategic Implications

The future of Inlyta hinges on its ability to adapt within an evolving therapeutic landscape. The drug’s key strengths—clinical efficacy, brand recognition, and strategic collaborations—offer a solid foundation. However, its trajectory will be heavily influenced by the successful approval and adoption of combination regimens with immune checkpoint inhibitors, which are rapidly becoming standard of care.

Pfizer’s strategy to position Inlyta as a component of multi-modality treatment options, especially in first-line settings, will be critical. This could involve leveraging real-world evidence to showcase improved outcomes, expanding into unserved markets, and investing in clinical trials for additional indications.

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Key Takeaways

• Market Growth: The global RCC market, propelled by rising cancer incidence and innovative therapies, offers a robust growth environment for Inlyta.
• Competitive Dynamics: Shifts toward immune-oncology combinations challenge monotherapy sales; Pfizer’s adaptation initiatives are essential.
• Revenue Potential: With strategic expansion and pipeline development, Inlyta’s peak global sales could approach $1 billion annually within five years.
• Strategic Risks: Patent expiry, regulatory hurdles, and pricing policies pose substantive challenges; proactive pipeline and partnership strategies mitigate these risks.
• Emerging Markets: Significant growth potential exists in Asia-Pacific and other developing regions, emphasizing the importance of regional market access strategies.

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FAQs

1. What are the main competitors of Inlyta in the RCC market?
Primary competitors include sunitinib, cabozantinib, lenvatinib, pazopanib, and immune checkpoint inhibitors like pembrolizumab and nivolumab, especially in combination regimens.

2. How does Inlyta’s efficacy compare to other targeted therapies?
Clinical trials like AXIS indicate superior PFS over sorafenib in second-line settings. Combination therapies pairing Inlyta with immunotherapies show promising superior outcomes compared to monotherapies.

3. What regulatory developments could impact Inlyta’s market?
Approval of Inlyta in new indications, especially in combination with immune checkpoint inhibitors, can expand its market. Conversely, patent expiry or biosimilar entries could diminish its exclusivity.

4. Which regions offer the highest growth opportunities for Inlyta?
Emerging markets in Asia-Pacific and Latin America present high growth potential due to increasing RCC diagnoses, healthcare infrastructure improvements, and expanding insurance coverage.

5. How is Pfizer positioning Inlyta for future growth?
Pfizer invests in clinical trials for combination therapies, markets in emerging regions, and collaborates with healthcare providers to enhance awareness and access, aiming to maintain and broaden Inlyta’s market share.

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References

1. Market Research Future. "Renal Cell Carcinoma Market Analysis." 2022.
2. Globocan 2020. "Cancer Incidence and Mortality Worldwide." International Agency for Research on Cancer.
3. Rini, B. I., et al. "Axitinib versus sorafenib in advanced renal-cell carcinoma." The New England Journal of Medicine, 2014.
4. Motzer, R. J., et al. "Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma." The New England Journal of Medicine, 2018.
5. Pfizer Inc. Annual Report 2022.