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 one branded drug marketed by Pf Prism Cv and is included in one NDA. 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-five 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:	175
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	158
Patent Applications:	6,907
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for axitinib

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for axitinib

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

Sponsor	Phase
Incyte Corporation	Phase 1/Phase 2
Cancer League of Colorado	Phase 2
University of Colorado, Denver	Phase 2

See all axitinib clinical trials

Generic filers with tentative approvals for AXITINIB

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

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		RX	Yes	Yes					Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No					Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes					Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No					Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No					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
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	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/002406 Inlyta 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
Singapore	11201605824X
Japan	3969669
Mexico	2009010761	FORMAS CRISTALINAS DE 6-[2-(METILCARBAMOIL)FENILSULFANIL]-3-E-[2-( PIRIDIN-2-IL)ETENIL]INDZOL ADECUADAS PARA EL TRATAMIENTO DEL CRECIMIENTO CELULAR ANORMAL EN MAMIFEROS. (CRYSTALLINE FORMS OF 6- [2- (METHYLCARBAMOYL) PHENYLSULFANYL] -3-E- [2- (PYRIDIN-2-YL) ETHENYL] INDAZOLE SUITABLE FOR THE TREATMENT OF ABNORMAL CELL GROWTH IN MAMMALS.)
Serbia	50339	JEDINJENJA INDAZOLA I FARMACEUTSKE KOMPOZICIJE ZA INHIBIRANJE PROTEIN KINAZA I POSTUPCI ZA NJIHOVU UPOTREBU (INDAZOLE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS FOR INHIBITING PROTEIN KINASES, AND METHODS FOR THEIR USE)
European Patent Office	1614683	Dérivés de l'indazole et leur utilisation dans des compositions pharmaceutiques pour l'inhibition de protéines kinases (Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use)

Supplementary Protection Certificates for axitinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2013003	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 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	PA2013003,C1218348	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	5/2013	Austria		PRODUCT NAME: AXITINIB; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903

Market Dynamics and Financial Trajectory for Axitinib

Introduction

Axitinib, a potent inhibitor of vascular endothelial growth factor receptors (VEGFRs), has been a significant player in the treatment of advanced renal cell carcinoma (RCC). Here, we delve into the market dynamics and financial trajectory of axitinib, highlighting its current status, future projections, and the factors influencing its market position.

Current Market Status

Market Size and Growth

The global axitinib market was valued at USD 5.42 billion in 2023 and is projected to reach USD 10.4 billion by 2031, growing at a compound annual growth rate (CAGR) of 9.2% from 2024 to 2031[4].

Clinical Use and Efficacy

Axitinib is primarily used as a second-line treatment for patients with advanced RCC who have failed initial systemic therapies such as sunitinib or cytokines. Clinical trials and observational studies have demonstrated its efficacy in improving progression-free survival (PFS) and overall survival (OS) compared to other treatments[1].

Market Drivers

Increasing Prevalence of Cancer

The global oncology drugs market, which includes axitinib, is driven by the rising prevalence of various cancers. The market is anticipated to grow significantly due to the increasing demand for innovative and effective treatment options[3].

Advancements in Targeted Therapies

The development of targeted therapies, such as axitinib, has revolutionized cancer treatment. These drugs offer higher efficacy and reduced side effects, contributing to their growing adoption and market growth[3].

Economic Evaluations and Cost-Effectiveness

While axitinib, particularly in combination with pembrolizumab, has shown to provide incremental benefits in terms of quality-adjusted life-years (QALYs), its cost-effectiveness remains a critical factor. Studies suggest that price reductions could make axitinib-based treatments more financially viable and less burdensome on healthcare systems[2].

Market Challenges

High Development and Treatment Costs

The high costs associated with the development and administration of axitinib pose a significant challenge. The treatment with pembrolizumab-axitinib, for instance, has a mean cost of $562,927, which can be prohibitive for many patients and healthcare systems[2].

Stringent Regulatory Environment

The oncology drugs market, including axitinib, is subject to stringent government regulations. These regulatory hurdles can slow down the approval and market entry of new treatments, affecting the financial trajectory of drugs like axitinib[3].

Competitive Landscape

Key Players

The market for axitinib is influenced by major pharmaceutical companies such as Pfizer, which is the primary developer and marketer of axitinib. Other key players in the oncology drugs market include Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, and AstraZeneca[3].

Financial Projections

Revenue Forecast

The revenue from axitinib is expected to increase substantially over the next few years, driven by its growing adoption as a second-line treatment for RCC. The projected growth rate of 9.2% CAGR from 2024 to 2031 indicates a robust financial trajectory for the drug[4].

Cost-Effectiveness Analysis

While the cost-effectiveness of axitinib, especially in combination with pembrolizumab, is a concern, sensitivity analyses suggest that adjustments in drug prices and overall survival rates can significantly impact the incremental cost-effectiveness ratio (ICER). For instance, the ICER could be reduced to around $89,983 per QALY with favorable pricing adjustments[2].

Regional Market Dynamics

Global Distribution

The market for axitinib is distributed across various regions, with North America currently contributing the largest share due to advanced healthcare infrastructure and high adoption rates. However, the Asia Pacific region is expected to witness the highest growth, driven by developing healthcare systems and increasing patient populations in countries like China and India[3].

Conclusion

Axitinib's market dynamics are characterized by strong growth potential, driven by its efficacy in treating advanced RCC and the increasing demand for targeted therapies. However, the high costs and stringent regulatory environment pose significant challenges. As the market continues to evolve, adjustments in pricing and further clinical evidence will be crucial in determining the long-term financial trajectory of axitinib.

Key Takeaways

• Axitinib's market size is projected to grow from USD 5.42 billion in 2023 to USD 10.4 billion by 2031.
• The drug is primarily used as a second-line treatment for advanced RCC.
• High development and treatment costs are significant challenges.
• Cost-effectiveness analyses suggest potential for improved financial viability with price adjustments.
• The Asia Pacific region is expected to drive future growth.

FAQs

What is the current market size of axitinib?

The global axitinib market was valued at USD 5.42 billion in 2023[4].

What is the projected growth rate of the axitinib market?

The axitinib market is expected to grow at a CAGR of 9.2% from 2024 to 2031[4].

What are the primary challenges facing the axitinib market?

High development and treatment costs, along with a stringent regulatory environment, are the main challenges[2][3].

Which regions are expected to drive the growth of the axitinib market?

North America currently leads, but the Asia Pacific region is expected to witness the highest growth due to developing healthcare infrastructure and increasing patient populations[3].

How does the cost-effectiveness of axitinib compare to other treatments?

Axitinib, particularly in combination with pembrolizumab, provides incremental benefits but may not be cost-effective at current prices. Price reductions could improve its cost-effectiveness[2].

Sources

1. MDPI: Axitinib after Treatment Failure with Sunitinib or Cytokines in ...
2. JAMA Network: Cost-effectiveness of Pembrolizumab Plus Axitinib vs Nivolumab ...
3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031
4. Market Research Intellect: Axitinib Market Size and Projections - Market Research Intellect