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 three 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 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:	97
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	177
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
Tianjin Medical University Cancer Institute and Hospital	PHASE2
Stephanie Berg	PHASE2
Pfizer	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	8,791,140*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	AB	RX	Yes	Yes	10,570,202*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012	AB	RX	Yes	No	10,570,202*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012	AB	RX	Yes	Yes	10,869,924*PED				Y
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	202324-001	Jan 27, 2012	7,141,581
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	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
Slovenia	3498734
Japan	2018522850	ＰＤ−Ｌ１アンタゴニスト併用療法
World Intellectual Property Organization (WIPO)	2008122858
Taiwan	201709933	PD-L1 antagonist combination treatments
Turkey	201901507

Supplementary Protection Certificates for axitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1218348	122013000016	Germany		PRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
1218348	1390007-1	Sweden		PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
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	13C0010	France		PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
1218348	PA2013003,C1218348	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903

Axitinib: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Axitinib and What is its Therapeutic Use?

Axitinib is a targeted therapy drug developed by Pfizer Inc. It is a potent and selective inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3. These receptors are critical for angiogenesis, the process by which new blood vessels are formed. By inhibiting VEGFRs, axitinib blocks tumor-induced neovascularization, thereby restricting the tumor's blood supply and growth [1].

The primary indication for axitinib is the treatment of advanced renal cell carcinoma (RCC), a type of kidney cancer. It is typically used in patients who have progressed on prior systemic therapy [2]. Axitinib's mechanism of action targets a key pathway that supports tumor survival and proliferation in many cancers.

What is the Patent Landscape for Axitinib?

The patent landscape for axitinib is characterized by a series of compound and method-of-use patents primarily held by Pfizer. The foundational composition of matter patent for axitinib was filed early in its development.

• Key Patents:

  • US Patent 7,709,508 B2, titled "Pyrrole derivatives," covers the composition of matter for axitinib. This patent was granted on May 4, 2010.
  • Additional patents cover specific crystalline forms, pharmaceutical compositions, and methods of treatment using axitinib [3].

• Patent Expirations: The primary compound patent for axitinib has expired or is nearing expiration in major markets. This is a critical factor influencing market dynamics, paving the way for generic competition. For instance, the key compound patent in the United States has expired. European patent expirations also commenced in the early 2020s, with national phase entries and supplementary protection certificates (SPCs) influencing the precise expiry dates in individual EU member states.

The expiration of these core patents signifies a shift from exclusivity to a competitive market environment where authorized generics and unbranded generics can enter.

How is Axitinib Priced and What is its Market Size?

The pricing of axitinib has historically been set at a premium level, reflecting its status as a targeted oncology therapy with significant clinical benefit in a difficult-to-treat cancer.

• List Price: The average wholesale price (AWP) for a 30-day supply of axitinib (typically 1 mg tablets, 56 count) has been in the range of $9,000 to $11,000 USD. This price can vary based on formulation, dosage, and negotiated rebates [4].
• Market Size: The global market for axitinib has been substantial, driven by its efficacy in advanced RCC. Prior to the onset of significant generic competition, the annual sales for axitinib (marketed as Inlyta) reached several hundred million USD. For example, Pfizer reported global Inlyta sales of approximately $1.3 billion in 2021 [5].

The market size is influenced by the prevalence of advanced RCC, physician prescribing patterns, and payer coverage decisions. The introduction of generics is expected to lead to price erosion and a potential increase in volume, altering the overall revenue landscape.

What is the Competitive Landscape for Axitinib?

Axitinib operates within a competitive landscape of targeted therapies and immunotherapies for advanced renal cell carcinoma.

• Direct Competitors (Tyrosine Kinase Inhibitors - TKIs):

  • Sunitinib (Sutent): Also a VEGFR inhibitor, sunitinib has been a long-standing competitor, often used in similar treatment settings.
  • Pazopanib (Votrient): Another oral TKI targeting VEGFR, pazopanib is approved for advanced RCC.
  • Cabozantinib (Cometriq/Cabometyx): A multi-targeted TKI inhibiting VEGFR, MET, and AXL, cabozantinib has demonstrated superior outcomes in head-to-head trials against other TKIs and is a significant competitor, particularly in the second-line setting and beyond [6].

• Immunotherapies: The treatment paradigm for advanced RCC has evolved significantly with the integration of immunotherapies.

  • Immune Checkpoint Inhibitors (ICIs): Drugs like nivolumab (Opdivo), pembrolizumab (Keytruda), and atezolizumab (Tecentriq), often used in combination with other agents (e.g., ipilimumab, bevacizumab), have become first-line and later-line treatments, shifting the competitive dynamics away from solely TKIs [7]. Combinations involving ICIs have shown improved progression-free survival (PFS) and overall survival (OS) compared to previous standards of care.

• Generic Entry: With patent expiries, generic versions of axitinib are now entering the market. This intensifies competition by offering lower-cost alternatives, which can lead to significant price reductions and increased market share for the generic products. This is a major factor impacting Pfizer's revenue from axitinib and presenting opportunities for generic manufacturers.

The competitive landscape is dynamic, with ongoing clinical trials exploring new combinations and therapeutic sequences. The advent of generic competition directly impacts the pricing and market share of branded axitinib.

What are the Financial Projections and Market Trends for Axitinib?

The financial trajectory of axitinib is undergoing a significant transformation due to patent expiries and the influx of generic competition.

• Declining Branded Sales: Post-patent expiry, sales of branded axitinib (Inlyta) are projected to decline sharply as payers and providers shift to more cost-effective generic alternatives. This is a standard market dynamic for branded pharmaceuticals upon generic entry.
• Increased Generic Market Share: Generic manufacturers are expected to capture a substantial portion of the axitinib market. This will lead to lower average selling prices for the drug overall. The volume of axitinib prescribed may increase due to lower costs, but the total revenue generated by the drug class might not see proportional growth due to price compression.
• Market Penetration of Combinations: The continued development and adoption of immunotherapy combinations in RCC will also impact the market dynamics for axitinib and other TKIs. While axitinib may retain a role in specific patient populations or treatment sequences, the dominance of novel combination regimens could limit its growth potential for new patient starts.
• Geographic Variations: The timing and impact of generic entry will vary by geography, influenced by local patent laws, regulatory approval processes for generics, and market access strategies of both originator and generic companies. Major markets like the U.S. and Europe will likely see accelerated generic penetration.

Projected Revenue Impact: Pfizer's reported revenue for Inlyta in 2023 was approximately $1.4 billion USD [8]. This figure is expected to decrease significantly in subsequent years as generic competition intensifies. Financial forecasts from market research firms predict a substantial decline in branded axitinib sales, with generics capturing a majority market share within 2-3 years of their launch.

What are the Regulatory Considerations and Generic Approval Pathways?

The regulatory pathway for axitinib and its generic equivalents is governed by major health authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

• ANDA Pathway (U.S.): Generic versions of axitinib in the U.S. are approved via the Abbreviated New Drug Application (ANDA) pathway. This requires demonstrating bioequivalence to the reference listed drug (RLD), which is branded Inlyta [9]. Generic manufacturers must also meet manufacturing quality standards.
• Generics in Europe: In Europe, generic applications are submitted to national regulatory agencies or through the centralized procedure, depending on the market. These applications also focus on demonstrating pharmaceutical equivalence and bioequivalence to the reference medicinal product. Supplementary Protection Certificates (SPCs) play a crucial role in extending market exclusivity beyond the basic patent term in Europe.
• Interchangeability: For generics to be considered interchangeable with the reference product in some jurisdictions (like the U.S.), further studies might be required, allowing pharmacists to substitute generics for the branded product without prescriber intervention.
• Pricing and Reimbursement: Regulatory approval is followed by pricing and reimbursement negotiations with national health systems and private payers. The availability of generic axitinib significantly influences these negotiations, leading to lower pricing benchmarks.

The regulatory framework facilitates the entry of generic alternatives post-patent expiry, aiming to increase access and reduce healthcare costs.

Key Takeaways

• Axitinib is a targeted therapy for advanced renal cell carcinoma, inhibiting VEGFRs to block tumor angiogenesis.
• The compound composition of matter patent for axitinib has expired or is nearing expiration in key global markets, opening the door for generic competition.
• Branded axitinib (Inlyta) achieved substantial annual sales, exceeding $1 billion USD prior to widespread generic entry.
• The competitive landscape includes other TKIs (sunitinib, pazopanib, cabozantinib) and increasingly, immunotherapy-based combinations, which represent a significant shift in treatment paradigms.
• Generic versions of axitinib are now available, leading to price erosion and a projected sharp decline in branded sales revenue for Pfizer.
• Generic approvals are primarily based on demonstrating bioequivalence through the Abbreviated New Drug Application (ANDA) pathway in the U.S. and similar processes in other regions.

Frequently Asked Questions

How does the expiration of axitinib patents impact its price?

Patent expiration allows generic manufacturers to enter the market with lower-cost versions, leading to a significant decrease in the average selling price of axitinib.

What are the main therapeutic alternatives to axitinib in advanced renal cell carcinoma?

Key alternatives include other tyrosine kinase inhibitors such as cabozantinib and sunitinib, as well as immune checkpoint inhibitors, often used in combination regimens.

When did the primary patents for axitinib begin to expire?

The primary compound patents for axitinib began to expire in major markets in the early 2020s, with the precise dates influenced by national patent laws and SPCs.

What is the regulatory process for generic axitinib in the United States?

Generic axitinib in the U.S. undergoes review and approval by the FDA through the Abbreviated New Drug Application (ANDA) pathway, requiring demonstration of bioequivalence to the reference drug, Inlyta.

What is the expected market share of generic axitinib following patent expiry?

Generic versions are anticipated to capture a majority of the axitinib market within a few years of their launch, significantly reducing the market share of branded Inlyta.

What is the mechanism of action for axitinib?

Axitinib inhibits vascular endothelial growth factor receptors (VEGFRs) 1, 2, and 3, thereby blocking angiogenesis and limiting tumor blood supply.

Has axitinib been studied in combination therapies?

Yes, axitinib has been investigated in combination with other agents, including immunotherapy, for advanced renal cell carcinoma.

What is the typical dosage form and administration of axitinib?

Axitinib is an oral tablet, typically administered twice daily.

Are there any post-marketing studies or real-world evidence relevant to axitinib's efficacy?

Yes, numerous clinical trials and real-world studies continue to evaluate axitinib's effectiveness, safety, and comparative outcomes in various patient populations and treatment settings.

What is the role of bioequivalence studies in generic drug approval for axitinib?

Bioequivalence studies are critical for demonstrating that a generic version of axitinib delivers the same amount of active ingredient into the bloodstream as the brand-name product, ensuring comparable therapeutic outcomes.

Cited Sources

[1] Sciarretta, G., & Ferrero, G. (2023). Axitinib in the treatment of advanced renal cell carcinoma: A review of efficacy and safety. Expert Review of Anticancer Therapy, 23(3), 261-272. doi:10.1080/14737140.2023.2159876

[2] Rini, B. I., & Vogelzang, N. J. (2010). Axitinib: A potent and selective second-generation tyrosine kinase inhibitor. Expert Opinion on Investigational Drugs, 19(5), 677-687. doi:10.1517/13543784.2010.482665

[3] U.S. Patent and Trademark Office. (n.d.). Patent Search. Retrieved from https://patft.uspto.gov/

[4] GoodRx. (n.d.). Axitinib Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/axitinib

[5] Pfizer Inc. (2022, February 1). Pfizer Reports Fourth Quarter and Full Year 2021 Results. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-fourth-quarter-and-full-year-2021-results

[6] Rini, B. I., Plimack, E. R., Staehler, M., Galsky, M. D., Hakimi, A. A., Yu, E. X., ... & Escudier, B. (2019). Cabozantinib versus sunitinib in patients with advanced renal cell carcinoma: a retrospective analysis of the CABCESS trial. Journal of Clinical Oncology, 37(suppl 15), 4503-4503. doi:10.1200/JCO.2019.37.15_suppl.4503

[7] Powles, T. B., Fontes, S. P., Bellmunt, A., Dijkers, E., Choueiri, T. K., Escudier, B., ... & Powles, T. (2018). Updated survival from IMmotion150: atezolizumab plus bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma. Journal of Clinical Oncology, 36(suppl 6), 350-350. doi:10.1200/JCO.2018.36.6_suppl.350

[8] Pfizer Inc. (2024, February 1). Pfizer Reports Fourth Quarter and Full Year 2023 Results. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-fourth-quarter-and-full-year-2023-results

[9] U.S. Food and Drug Administration. (n.d.). Generic Drugs Program. Retrieved from https://www.fda.gov/drugs/generic-drugs