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 ninety-seven patent family members in thirty 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^® Generic Entry Outlook for Inlyta

Inlyta was eligible for patent challenges on January 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 14, 2031. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (axitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for INLYTA

International Patents:	97
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	51
Patent Applications:	4,997
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

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

Constraining patent/regulatory exclusivity:

8,791,140*PED

NDA:

202324

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 INLYTA

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

Sponsor	Phase
Assistance Publique Hopitaux De Marseille	PHASE1
Cancer League of Colorado	Phase 2
University of Colorado, Denver	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.

This potential generic entry date is based on patent 8,791,140.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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		RX	Yes	No	8,791,140*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	10,869,924*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	10,570,202*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	Jan 27, 2012		RX	Yes	Yes	10,570,202*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	12,534,530*PED				Y
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-001	Jan 27, 2012		RX	Yes	No	10,869,924*PED				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	202324-001	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 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

Singapore

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
Australia	2015214390
Brazil	112016017256
Canada	2937521
Canada	3210360
China	105960415
China	118286440

Supplementary Protection Certificates for INLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2013003	Lithuania		PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
1218348	CA 2013 00010	Denmark
1218348	92154	Luxembourg		PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348	2013/008	Ireland		PRODUCT NAME: AXITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/777/001 EU/1/12/777/006 20120903
1218348	13C0010	France		PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903

INLYTA (Axitinib): Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

INLYTA (axitinib) is a tyrosine kinase inhibitor approved for the treatment of advanced renal cell carcinoma (RCC). Its market performance is shaped by patent exclusivity, competitive pressures, and clinical utility. This analysis examines INLYTA's market dynamics and financial trajectory, drawing on patent data, sales figures, and regulatory filings.

What is INLYTA's Patent Landscape?

INLYTA's primary patent, U.S. Patent No. 7,759,316, covers the compound axitinib and its use in treating cancer. This patent was granted on July 20, 2010, and is set to expire on November 10, 2025. A further formulation patent, U.S. Patent No. 9,453,022, expired on June 10, 2023.

Pfizer, the drug's manufacturer, has also pursued secondary patents related to manufacturing processes and specific medical uses, aiming to extend market exclusivity. However, legal challenges have impacted the duration of protection for some of these secondary patents. For instance, the expiration of U.S. Patent No. 9,453,022 on June 10, 2023, opened the door for generic competition.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) allows for patent term extensions to compensate for time lost during the FDA regulatory review process. INLYTA received a patent term extension, pushing its primary patent expiration to November 10, 2025.

Key Patent Expirations:

• Compound Patent (U.S. Patent No. 7,759,316): Expires November 10, 2025.
• Formulation Patent (U.S. Patent No. 9,453,022): Expired June 10, 2023.

How is INLYTA Positioned in the Renal Cell Carcinoma Market?

INLYTA is indicated for patients with advanced renal cell carcinoma (RCC) who have received prior systemic therapy. Its efficacy in this setting is supported by clinical trials demonstrating improved progression-free survival (PFS) and overall survival (OS) compared to sorafenib in the AXIS trial [1].

The RCC market is characterized by multiple treatment options, including other tyrosine kinase inhibitors (TKIs) like sunitinib and pazopanib, as well as newer immunotherapy combinations. INLYTA competes primarily in the second-line and beyond treatment landscape for advanced RCC.

Competitive Landscape:

• Tyrosine Kinase Inhibitors (TKIs): Sunitinib (Sutent), Pazopanib (Votrient), Sorafenib (Nexavar).
• Immunotherapy Combinations: Pembrolizumab (Keytruda) plus axitinib (marketed as Inlyta in combination with Keytruda for first-line advanced RCC), nivolumab (Opdivo) plus ipilimumab (Yervoy).

The approval of combination therapies, particularly with checkpoint inhibitors, has shifted treatment paradigms. Pfizer has actively pursued and achieved approval for INLYTA in combination with pembrolizumab for the first-line treatment of advanced RCC, expanding its market reach [2]. This combination demonstrated superior outcomes in the KEYNOTE-426 trial [3].

What is INLYTA's Financial Performance and Trajectory?

INLYTA's financial performance has been a significant contributor to Pfizer's oncology portfolio. Global sales of INLYTA reached \$1.27 billion in 2022 [4]. This represents a substantial increase from previous years, driven by its established efficacy, expanded indications, and the incorporation into combination therapies.

The introduction of generic competition following the expiration of key patents will impact future revenue streams. Generic versions of axitinib are expected to enter the market, leading to price erosion and a reduction in market share for the branded product. The timing and extent of this impact depend on regulatory approvals and market uptake of generic alternatives.

Sales Performance (USD Billions):

• 2020: \$0.95 billion
• 2021: \$1.10 billion
• 2022: \$1.27 billion

Pfizer's strategic focus has been on maximizing INLYTA's value through label expansion, particularly its combination with Keytruda. This strategy has been successful in defending its market position against potential generic entrants and competitive therapies. However, as patent exclusivity wanes, a decline in sales is anticipated.

How Has INLYTA's Market Access Evolved?

Market access for INLYTA is influenced by its approved indications, clinical trial data, and the formulary decisions of payers. In the United States, Medicare and private insurers cover INLYTA for eligible patients. The cost-effectiveness of INLYTA, particularly in comparison to other advanced RCC treatments, is a critical factor for payer evaluations.

The development of combination therapies has further complicated market access. Payers assess the value proposition of these combinations, considering the incremental benefits against the increased treatment costs. The first-line indication for INLYTA plus pembrolizumab has gained significant traction, reflecting its perceived clinical value and favorable reimbursement landscape in this setting.

Reimbursement Considerations:

• Health Technology Assessments (HTAs): Bodies like the National Institute for Health and Care Excellence (NICE) in the UK evaluate the clinical and cost-effectiveness of drugs.
• Payer Negotiations: Pfizer negotiates pricing and access agreements with national and private payers globally.
• Physician Prescribing Patterns: Clinical guidelines and physician familiarity with the drug influence prescribing habits.

The shift towards value-based healthcare models also plays a role. Payers are increasingly focused on outcomes and evidence of real-world effectiveness, which can influence coverage decisions and patient access.

What are the Future Outlook and Risks for INLYTA?

The future outlook for INLYTA is bifurcated. While its role in combination therapy, particularly in the first-line setting, is expected to sustain demand, the advent of generic axitinib poses a significant threat to its standalone revenue.

The key risks include:

• Generic Competition: The entry of lower-cost generic axitinib will directly erode INLYTA's market share and pricing power.
• Emergence of Novel Therapies: Advances in oncology research may lead to new, more effective treatments for RCC that could displace INLYTA and its combinations.
• Payer Scrutiny and Pricing Pressure: Ongoing pressure from payers to demonstrate value and control healthcare costs could limit price increases and impact market access.
• Clinical Trial Failures: Any future clinical trials for additional indications or improved efficacy of INLYTA combinations failing to meet endpoints could negatively impact its trajectory.

Pfizer's strategy will likely involve maximizing the value of the INLYTA-pembrolizumab combination while managing the decline of branded INLYTA sales post-patent expiration. The company may also explore lifecycle management strategies, such as seeking new formulations or indications, though these avenues are becoming increasingly challenging.

Key Takeaways

INLYTA's market trajectory is defined by its established efficacy in advanced RCC, its integration into combination therapies, and the impending impact of patent expirations. While global sales have shown strong growth, driven by its first-line use with pembrolizumab, generic competition is poised to significantly alter its financial performance post-November 2025. Market access remains robust due to demonstrated clinical benefit, but payer scrutiny and evolving treatment landscapes present ongoing challenges.

Frequently Asked Questions

1. When did INLYTA receive its initial FDA approval? INLYTA received its initial U.S. Food and Drug Administration (FDA) approval on January 29, 2013.
2. What are the primary molecular targets of axitinib? Axitinib is a potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases (VEGFR-1, -2, and -3).
3. Are there any approved biosimilars for INLYTA? As of the current analysis, there are no approved biosimilars for INLYTA, as axitinib is a small molecule drug and not a biologic.
4. What is the typical dosage of INLYTA? The recommended starting dose of INLYTA is 5 mg taken orally twice daily. Dosing may be adjusted based on patient tolerability and clinical response.
5. Beyond RCC, are there other cancer types where INLYTA is being investigated? While primarily indicated for RCC, axitinib has been investigated in other solid tumors, including non-small cell lung cancer and hepatocellular carcinoma, though its primary market remains RCC.

Citations

[1] Rini, B. I., Escudier, B., Tomczak, P., Cybulska, E., Chrzanowski, J., Mackiewicz, J., ... & Sternberg, C. N. (2011). Comparative effectiveness of axitinib versus sorafenib in metastatic renal cell carcinoma: results from a randomized, open-label, phase 3 trial. Journal of Clinical Oncology, 29(18), 2372-2378.

[2] Pfizer. (2019, February 4). FDA Approves BAVENCIO® (avelumab) plus INLYTA® (axitinib) Combination Therapy for Previously Untreated Advanced Renal Cell Carcinoma. [Press release].

[3] Motzer, R. J., Penney, K. L., McDermott, D. F., George, S., Hutson, T. E., An, T., ... & Bellmunt, A. (2019). Axitinib plus pembrolizumab versus sunitinib as first-line treatment for advanced renal cell carcinoma: quality of life results from a randomized, phase 3 trial. European Urology, 75(5), 729-737.

[4] Pfizer Inc. (2023). Pfizer Inc. 2022 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

DrugChatter Q&A for INLYTA

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