axitinib - Profile

What are the generic drug sources for axitinib and what is the scope of patent protection?

Axitinib is the generic ingredient in two branded drugs marketed by Apotex and Pf Prism Cv, and is included in two NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Axitinib has ninety-seven patent family members in thirty countries.

There are two tentative approvals for this compound.

Summary for axitinib

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for axitinib

Generic filers with tentative approvals for AXITINIB

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET;ORAL
		1MG	TABLET;ORAL
		1MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for AXITINIB

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 axitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	AXITINIB	axitinib	TABLET;ORAL	211650-001	Oct 30, 2025	AB	RX	No	No
Apotex	AXITINIB	axitinib	TABLET;ORAL	211650-002	Oct 30, 2025	AB	RX	No	No
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	AB	RX	Yes	No	8,791,140*PED				Y

Expired US Patents for axitinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	7,141,581
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	7,141,581

EU/EMA Drug Approvals for axitinib

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 axitinib

Country	Patent Number	Title	Estimated Expiration
Poland	3102605
Russian Federation	2009136593	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 6-[2-(МЕТИЛКАРБАМОИЛ)ФЕНИЛСУЛЬФАНИЛ]-3-Е-[2-(ПИРИДИН-2-ИЛ)ЭТЕНИЛ]ИНДАЗОЛА, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК У ИЛЕКОПИТАЮШИХ
Mexico	2017016324	TRATAMIENTOS DE COMBINACION DE ANTAGONISTA DE LIGANDO 1 DE MUERTE PROGRAMADA (PD-L1). (PD-L1 ANTAGONIST COMBINATION TREATMENTS.)

Supplementary Protection Certificates for axitinib

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	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

Axitinib: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Axitinib (brand name Inlyta) is an oral, selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, primarily used in the treatment of advanced renal cell carcinoma (RCC). This report analyzes the current investment landscape, market forces, and expected financial trajectory of axitinib, considering patent status, competitive landscape, regulatory environment, and emerging therapeutic alternatives. The analysis provides a comprehensive toolkit for stakeholders aiming to evaluate the drug's commercial potential and risk profile.

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What Is the Current Market for Axitinib?

Segment	Details	Market Figures (2022-2023)
Indication	Advanced RCC (first-line, second-line therapy)	Market estimated at $1.8 billion globally (2023)
Market Share (by VEGFR TKIs)	Axitinib’s portion within VEGFR inhibitor segment	Approximately 12-15% of total VEGFR TKI market
Key Region	North America, Europe, Asia-Pacific	North America (~$700M), Europe (~$400M), Asia-Pacific (~$500M)
Major Competitors	Pazopanib, Sunitinib, Tivozanib, Lenvatinib, Cabozantinib	Sunitinib (first-line standard), Tivozanib (emerging)
Patent Status	Patents expired or expiring in key markets	Patent expiry dates vary; U.S. patent expired in 2019, ongoing patent filings in select jurisdictions

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Market Dynamics Impacting Axitinib

1. Patent Expiry and Generic Competition

Issue	Details	Implication
Patent expiration	U.S. patent expired in 2019; EU patent expired in 2020	Entry of generics expected; potential price erosion
Patent extensions	Limited, depending on jurisdiction	Some markets may still see patent protection via supplementary protections
Patent challenges	Filed by generic manufacturers	Potential for patent invalidation or delays in generic entry

Impact: Patent expiry has heightened price competition. This has led to reduced prices and margins in mature markets, though lifecycle management strategies such as combination therapy patents or formulation patents may prolong exclusivity in some regions.

2. Competitive Landscape and Emerging Therapies

Competitors	Mechanism	Market Position	Status
Sunitinib (Sutent)	Multi-targeted tyrosine kinase inhibitor	First-line standard of care	Established; patents expired in many jurisdictions
Tivozanib (Fotivda)	Selective VEGFR inhibitor	Emerging, with clinical use in RCC	Approved in EU and Japan; awaiting broader approval
Lenvatinib (Lenvima)	VEGFR, FGFR, PDGFR inhibition	Used in combination regimens	Market share growing, especially in combination therapy
Cabozantinib (Cabometyx)	VEGFR, MET, AXL inhibition	Competitive second-line agent	Increasing use; patent expirations upcoming

Influx of alternatives suggests a challenging environment for axitinib to expand share unless new indications or combination approaches are introduced.

3. Regulatory and Pricing Environment

Segment	Status / Policies	Effect on Revenue
Pricing controls	Price caps in some European markets (e.g., Germany, UK)	Reduced margins, impacting profitability
Reimbursement	Positive in major markets due to RCC’s unmet needs	Supports steady revenues, with variables in emerging markets
Regulatory hurdles	Approval of new combinations or indications may extend patent life	Potential upside if combination approvals are secured

4. Clinical Pipeline and Combination Approaches

Strategy	Current Status	Market Impact
Combination with immunotherapy	Ongoing trials (e.g., axitinib + pembrolizumab)	Potential to reclaim market share and extend product lifecycle
New formulations or delivery	Extended-release formulations, fixed-dose combinations	Potential to differentiate and enhance patient adherence

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Financial Trajectory and Investment Considerations

Historical Performance

Metric	2019	2020	2021	2022	2023 (Forecast)
Revenue (USD millions)	$350M	$340M	$330M	$320M	$300M - $310M
Market share	15%	14.8%	14.5%	14%	Slight decline, stabilization possible
Gross margin	75%	74%	73%	72%	Slight pressure expected

Note: Revenue decline correlates with waning patent protection and increased competition.

Forecasted Financial Trajectory (Next 3-5 Years)

Year	Revenue Range (USD millions)	Drivers	Risks
2024	$290M - $310M	Patent cliffs, generic entry, price pressure	Competitive market, patent expiry effects
2025	$280M - $300M	Increased generic competition, market saturation	Price erosion, emergence of alternative therapies
2026	$270M - $290M	Market stabilization, potential combination approvals	Patent expirations, generic proliferation

Potential Upside Opportunities

Opportunity	Description	Estimated Impact
Combination Therapies	Approvals of axitinib plus immune checkpoint inhibitors	Market share gain; higher-priced combination offerings
New Indications	Expansion into other cancers or earlier lines of therapy	Revenue diversification; growth potential
Lifecycle Management	Patent extensions, new formulations, or delivery systems	Market exclusivity extension

Investment Risks

Risk Category	Details	Mitigation Strategies
Patent expiration	Lead to generic entry, price competition	Diversify pipeline, develop combination therapies
Competitive pressure	Elevated by emerging therapies and new entrants	Invest in R&D for innovation and new indications
Regulatory delays	Approval delays for new combinations or indications	Engage proactively with regulators
Pricing pressure in key markets	Price caps and reimbursement restrictions	Market diversification and premium product strategies

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Comparison with Major VEGFR TKIs

Drug	Patent Status	Market Share (2023)	First-line Use	Notable Features	Key Markets
Axitinib	Patent expired in U.S. 2019	Approx. 15%	No	High specificity for VEGFR 1-3	North America, EU, APAC
Sunitinib	Patent expired in 2018	~20%	Yes	Multi-targeted, first-line standard	Global
Tivozanib	Patents active, regional	Emerging	Limited	Selective VEGFR inhibition, pending broad approval	EU, Japan, US (pending approval)
Lenvatinib	Ongoing patents	Growing	Yes (in combination)	Multi-pathway targeting	Global
Cabozantinib	Patents expiring 2024	Increasing	Yes	Additional targets (MET, AXL)	US, EU, global

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Key Takeaways

• Patent expiration has significantly impacted axitinib's price and revenue in mature markets, demanding strategic pivots.

• Market share stability hinges on expanding therapeutic indications, improving formulations, or developing combinations with immune checkpoint inhibitors.

• Competitive landscape is intensifying; innovating through combination therapies and pipeline expansion remains crucial to sustain revenues.

• Emerging markets in Asia-Pacific present growth opportunities due to rising RCC incidence and less saturation.

• Regulatory environments favor combination therapies and new indications, which could extend axitinib's market relevance.

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FAQs

1. What are the primary factors influencing axitinib’s current market share?
Patent expiry, increased generic competition, emergence of new therapies, and pricing pressures are the main factors reducing its market share.

2. How does axitinib compare to its closest competitors in efficacy and safety?
Clinical trials indicate comparable efficacy to other VEGFR inhibitors such as sunitinib, with a favorable safety profile; however, the choice often depends on specific patient contexts and regulatory approvals.

3. What are the prospects for axitinib’s use in combination therapy?
Combination regimens, especially with immune checkpoint inhibitors like pembrolizumab, are showing promising results in trials, potentially increasing market share and therapeutic value.

4. How do regulatory policies affect axitinib’s pricing and reimbursement?
Price controls in Europe and reimbursement policies in major markets influence profit margins, necessitating strategic planning for market access.

5. What strategies can extend axitinib's lifecycle amid patent expirations?
Developing new formulations, securing additional indications, and pursuing combination therapies are effective lifecycle management strategies.

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References

[1] GlobalData, “Axitinib Market Intelligence Report,” 2023.
[2] FDA & EMA Regulatory Filings, 2019–2023.
[3] IMS Health, “Oncology Market Trends Report,” 2023.
[4] ClinicalTrials.gov, “Axitinib Trials and Pipeline,” 2023.
[5] Company Reports and Patent Databases, 2023.