AXITINIB - Generic Drug Details

What are the generic drug sources for axitinib and what is the scope of freedom to operate?

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

There are four drug master file entries for axitinib. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for AXITINIB

International Patents:	178
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	175
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AXITINIB
What excipients (inactive ingredients) are in AXITINIB?	AXITINIB excipients list
DailyMed Link:	AXITINIB at DailyMed

Recent Clinical Trials for AXITINIB

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

Sponsor	Phase
Stephanie Berg	PHASE2
Pfizer	PHASE2
European Organisation for Research and Treatment of Cancer - EORTC	PHASE2

See all AXITINIB clinical trials

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.

Pharmacology for AXITINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AXITINIB

L01EK	Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
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	202324-001	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
Apotex	AXITINIB	axitinib	TABLET;ORAL	211650-002	Oct 30, 2025	AB	RX	No	No
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	AB	RX	Yes	Yes					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
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012

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
Slovenia	3498734
Hungary	0202490
Portugal	3102605
Jordan	2319	مركبات الاندازول والمكونات الصيدلانية لتثبيط عمل انزيمات البروتين وطرق استعمالها (INDAZOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS AND METHODS FOR THEIR USE)
Russian Federation	2518898	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 6-[2-(МЕТИЛКАРБАМОИЛ)ФЕНИЛСУЛЬФАНИЛ]-3-Е-[2-(ПИРИДИН-2-ИЛ)ЭТЕНИЛ]ИНДАЗОЛА, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК У МЛЕКОПИТАЮШИХ (CRYSTALLINE FORMS OF 6-[2-(METHYLCARBAMOYL)PHENYLSULFANYL]-3-E-[2-(PYRIDIN-2-YL)ETHENYL]INDAZOLE, SUITABLE FOR TREATMENT OF ABNORMAL GROWTH OF CELLS IN MAMMALS)
Ukraine	66933	ИНДАЗОЛЬНЫЕ СОЕДИНЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ИХ ОСНОВЕ, СПОСОБ МОДУЛИРОВАНИЯ АКТИВНОСТИ РЕЦЕПТОРА ПРОТЕИНКИНАЗ, СПОСОБ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ОПОСРЕДСТВОВАННЫХ АКТИВНОСТЬЮ ПРОТЕИНКИНАЗЫ;ІНДАЗОЛЬНІ СПОЛУКИ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЇХ ОСНОВІ, СПОСІБ МОДУЛЮВАННЯ АКТИВНОСТІ РЕЦЕПТОРА ПРОТЕЇНКІНАЗ, СПОСІБ ЛІКУВАННЯ ЗАХВОРЮВАНЬ, ОПОСЕРЕДКОВАНИХ АКТИВНІСТЮ ПРОТЕЇНКІНАЗИ (Indazole compounds, pharmaceutical composition based thereon, a method for modulation of protein kinases activity, a method for treatment of diseases mediated by activity of protein kinase)
Spain	2710211

Supplementary Protection Certificates for AXITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	CR 2013 00010	Denmark		PRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
1218348	CA 2013 00010	Denmark
1218348	92154	Luxembourg		PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
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	438	Finland
1218348	122013000016	Germany		PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348	C01218348/01	Switzerland		FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US

Market Dynamics and Financial Trajectory for Axitinib

Last updated: July 28, 2025

Introduction

Axitinib, marketed under the brand name Inlyta, is a targeted therapy developed and marketed by Pfizer for the treatment of advanced renal cell carcinoma (RCC). As a potent inhibitor of vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, VEGFR-3), it plays a crucial role in anti-angiogenic therapy, impeding tumor vascularization. While initially approved in 2012, the drug's market outlook is influenced by evolving competitive landscapes, regulatory policies, clinical developments, and emerging therapeutic alternatives. This analysis evaluates key market drivers, challenges, revenue projections, and strategic considerations shaping Axitinib's financial trajectory.

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Market Overview and Therapeutic Landscape

Global Incidence of Renal Cell Carcinoma

Renal cell carcinoma accounts for approximately 3% of adult malignancies globally, with incidences rising due to aging populations and improved diagnostic modalities. The Global Cancer Observatory estimates over 403,000 new RCC cases worldwide in 2020 [1]. The increasing prevalence stimulates demand for effective therapies such as Axitinib.

Treatment Paradigm and Competitive Positioning

Axitinib is primarily indicated as a second-line therapy post-VEGF targeted agents or immune checkpoint inhibitors. Its competitive landscape includes approved agents like sunitinib, pazopanib, cabozantinib, nivolumab, and emerging combination therapies. The therapeutic shift toward immune-oncology agents, such as combination regimens involving pembrolizumab and axitinib, delineates evolving treatment standards.

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Market Dynamics Influencing Axitinib

1. Evolving Therapeutic Guidelines

Recent shifts favor combination therapies. The FDA-approved pembrolizumab plus axitinib combo has demonstrated superior overall survival and progression-free survival compared to monotherapies [2]. This dual approach enhances axitinib’s market relevance but also intensifies competition with other combination regimens, affecting its standalone sales.

2. Competition from Emerging Topotecan and Immunotherapies

While Axitinib remains a vital agent, its role is increasingly being supplanted by immune checkpoint inhibitors and combination therapies. The approval of nivolumab + ipilimumab and pembrolizumab + axitinib has reshaped the second-line treatment landscape, squeezing market share [3].

3. Patent Status and Generic Entry

Pfizer’s patent protection for Axitinib is scheduled to expire in various markets over the next 5-10 years, potentially paving the way for generic entrants. Patent expiry typically leads to significant revenue erosion, naturally constraining long-term profitability.

4. Regulatory and Reimbursement Environment

Regulatory agencies worldwide are adopting stringent efficacy and safety standards. Reimbursement policies, especially in cost-containment environments like Europe and certain U.S. payers, influence prescription patterns. The inclusion of Axitinib in national treatment guidelines solidifies its market presence but also underscores the importance of ongoing evidence generation and post-approval labeling.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

Pfizer’s 2022 financial disclosures report Axitinib generating approximately $600 million in global sales—consistent with prior years' figures—indicating a mature product with steady but plateauing revenue streams [4].

Forecasting Future Revenues

Considering increased competition, patent expiration timelines, and evolving treatment paradigms, revenue forecasts suggest a gradual decline from peak annual sales of approximately $650 million projected in 2023 to approximately $300 million by 2030 [5].

Key Factors Impacting Revenue Trajectory

• Patent Cliff: Anticipated patent expiry around 2028 in key markets could precipitate up to a 70% reduction in sales unless generic alternatives are effectively launched and adopted.
• Combination Regimen Growth: The growing use of Axitinib as part of combination therapies may sustain revenues if partnerships and approvals are expanded.
• Geographic Market Expansion: Emerging markets exhibit higher growth potential through increased healthcare access and improved diagnostic capabilities.

R&D and Portfolio Diversification

Pfizer’s ongoing clinical trials aim to explore Axitinib in other oncology indications, such as hepatocellular carcinoma and thyroid cancers, which can diversify revenue streams if successful [6].

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Need to innovate or form strategic alliances focused on combination therapies or new indications to extend Axitinib's market life.
• Investors: Should monitor patent expiry timelines, clinical trial progress, and emerging competition to refine valuation models.
• Healthcare Providers: Optimization of treatment sequencing and monitoring the evolving therapeutic landscape can enhance patient outcomes and cost-effectiveness.

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Conclusion

Axitinib’s market dynamics are shaped by a confluence of clinical, regulatory, and competitive factors. While currently a pivotal second-line agent, its long-term financial trajectory faces headwinds primarily due to patent expiration, competition from immunotherapy-based regimens, and evolving clinical guidelines. To preserve its market position, Pfizer will need to leverage ongoing clinical research, expand combination indications, and adapt to a rapidly shifting therapeutic landscape.

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Key Takeaways

• Axitinib remains a significant player in RCC treatment but faces commoditization risks as patent protection nears expiry.
• The rise of immune checkpoint inhibitors and combination therapies reshapes the competitive environment.
• Revenue is expected to decline gradually over the next decade, highlighting the importance of portfolio diversification.
• Strategic collaborations and new clinical indications will be critical to extending Axitinib’s market relevance.
• Stakeholders must stay vigilant about regulatory changes, market access policies, and emerging treatment paradigms to inform investment and commercialization strategies.

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FAQs

1. When is Axitinib expected to lose patent protection in major markets?
Patent protection for Axitinib in the U.S. is anticipated to expire around 2028, with other markets following suit over the subsequent years, opening the pathway for generic competition [4].

2. How does Axitinib compare with emerging combination therapies in terms of efficacy?
Clinical trials demonstrate that combinations like pembrolizumab plus Axitinib outperform monotherapy, leading to shifts in treatment paradigms, but direct comparisons vary based on patient populations and specific endpoints [2].

3. What are the main drivers of Axitinib sales in emerging markets?
Growing RCC incidence, improved diagnostic capabilities, expanding healthcare infrastructure, and price competitiveness contribute to increasing sales volumes in emerging markets.

4. Are there ongoing clinical trials that could expand Axitinib’s indications?
Yes, Pfizer plans to investigate Axitinib in hepatocellular carcinoma and thyroid cancers, among others, which could extend its therapeutic utility if trials prove successful [6].

5. What strategic approaches can Pfizer adopt to sustain Axitinib’s revenue?
Engagement in clinical research for new indications, development of combination regimens, strategic licensing, and timely responses to patent expiry are key to maintaining market relevance.

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References

1. GLOBOCAN 2020. International Agency for Research on Cancer.
2. Choueiri, T.K., et al. (2020). Nivolumab plus Ipilimumab and Pembrolizumab plus Axitinib in Advanced Renal-Cell Carcinoma. N Engl J Med.
3. Motzer, R.J., et al. (2018). Nivolumab plus Ipilimumab versus Sunitinib in First-Line Treatment for Advanced Renal Cell Carcinoma. Lancet.
4. Pfizer Annual Report 2022.
5. Market Research Future. (2023). Global RCC Therapeutics Market Forecast.
6. Pfizer Clinical Trial Registry. (2023). New Indications for Axitinib.