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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 one hundred and seventy-four patent family members in fifty-seven 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 three 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:	174
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	50
Patent Applications:	4,117
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
Cancer League of Colorado	Phase 2
University of Colorado, Denver	Phase 2
Lynkcell Europe	Phase 1

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	6,534,524*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

Expired US Patents for INLYTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324-002	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 INLYTA

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 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

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
Luxembourg	92154
World Intellectual Property Organization (WIPO)	2008122858
European Patent Office	3498734	COMBINAISON D'UN ANTAGONISTE PD-1 ET D'UN INHIBITEUR VEGFR POUR LE TRAITEMENT DU CANCER (COMBINATION OF A PD-1 ANTAGONIST AND A VEGFR INHIBITOR FOR TREATING CANCER)

Supplementary Protection Certificates for INLYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2013C/015	Belgium		PRODUCT NAME: AXITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/777/001 20120905
1218348	92154	Luxembourg		PRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE

INLYTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Inlyta

Introduction to Inlyta

Inlyta, with the active substance axitinib, is a tyrosine kinase inhibitor used to treat adults with advanced renal cell carcinoma (RCC), a type of kidney cancer. It works by blocking vascular endothelial growth factor (VEGF) receptors, thereby reducing the growth and spread of cancer cells and cutting off their blood supply[1].

Market Overview of Kidney Cancer Drugs

The global kidney cancer drugs market has been experiencing significant growth, driven by an increasing number of patients suffering from kidney cancer. This growth is attributed to factors such as unhealthy diets, pollution, and lifestyle changes. The market was valued at USD 2.6 billion in 2013 and was expected to reach USD 4.5 billion by 2020, growing at a CAGR of 6.6%[3].

Competitive Landscape

The kidney cancer drugs market is highly competitive and fragmented, with both established and emerging players. To stay competitive, companies are adopting strategies such as mergers, collaborations, and significant investments in research and development. The market dominance is shared among various drugs, including Inlyta, Votrient (pazopanib), Avastin (bevacizumab), Torisel (temsirolimus), and newer immunotherapies like Opdivo and Keytruda[3].

Efficacy and Clinical Performance of Inlyta

Inlyta has demonstrated efficacy in treating advanced RCC, particularly in patients who have failed previous treatments with other cancer medicines such as sunitinib or cytokines. In a key study involving 723 patients, Inlyta showed better outcomes compared to sorafenib, with patients on Inlyta living an average of 6.7 months without disease progression, compared to 4.7 months for those on sorafenib[1].

Side Effects and Safety Profile

While Inlyta is effective, it comes with a range of side effects, including diarrhea, hypertension, fatigue, dysphonia, nausea, vomiting, decreased appetite, weight loss, and palmar-plantar erythrodysaesthesia syndrome. The most common Grade 3/4 adverse reactions include hypertension, diarrhea, and fatigue. Despite these side effects, the European Medicines Agency (EMA) has concluded that the benefits of Inlyta outweigh its risks[1][5].

Financial Performance and Revenue

Inlyta is a part of Pfizer's oncology portfolio, which has seen significant financial activity. While Pfizer's overall revenues have been impacted by the decline in COVID-related products like Comirnaty and Paxlovid, the company's oncology segment has shown resilience. Excluding contributions from COVID-related products, Pfizer's revenues have grown operationally, driven in part by the performance of its oncology products, including Inlyta[2][4].

Revenue Projections and Market Impact

The global revenue for Inlyta, along with other kidney cancer drugs, has been steadily increasing. For instance, the global Inlyta market revenue was tracked from 2012 to 2020, showing a consistent growth trend. While specific recent revenue figures for Inlyta alone are not provided, the overall growth in the kidney cancer drugs market and Pfizer's operational revenue growth suggest a positive financial trajectory for Inlyta[3].

Regional Market Analysis

North America is expected to be a key region for the growth of the kidney cancer drugs market, including Inlyta, due to the increasing demand for effective treatments and the presence of well-developed healthcare infrastructure and favorable reimbursement policies[3].

Challenges and Opportunities

Despite the growth potential, the kidney cancer drugs market, including Inlyta, faces challenges such as the high cost of medications and treatment methodologies. However, the introduction of novel drugs like immunotherapies and the expansion of online sales platforms are expected to boost market growth. The market is also driven by the rising geriatric population and changes in lifestyle, which increase the incidence of kidney cancer[3].

Strategic Initiatives and Cost Savings

Pfizer, the manufacturer of Inlyta, has been implementing various strategic initiatives to optimize its operations and reduce costs. For example, the company launched a manufacturing optimization program aimed at achieving approximately $1.5 billion in cost savings by the end of 2027. These initiatives are expected to enhance the financial performance and competitiveness of Pfizer's oncology products, including Inlyta[4].

Key Takeaways

• Efficacy: Inlyta has shown superior efficacy in treating advanced RCC compared to other treatments like sorafenib.
• Market Growth: The global kidney cancer drugs market is growing, driven by increasing patient numbers and demand for effective treatments.
• Financial Performance: Despite overall revenue declines due to COVID-related products, Pfizer's oncology segment, including Inlyta, has shown operational growth.
• Challenges: High treatment costs and competitive market dynamics are key challenges.
• Strategic Initiatives: Pfizer's cost-saving programs and strategic acquisitions are expected to enhance the financial trajectory of Inlyta.

FAQs

Q: What is Inlyta used for? A: Inlyta is used to treat adults with advanced renal cell carcinoma (RCC), a type of kidney cancer.

Q: How does Inlyta work? A: Inlyta works by blocking VEGF receptors, reducing the growth and spread of cancer cells and cutting off their blood supply.

Q: What are the common side effects of Inlyta? A: Common side effects include diarrhea, hypertension, fatigue, dysphonia, nausea, vomiting, and decreased appetite.

Q: How does Inlyta compare to other treatments? A: Inlyta has shown better outcomes compared to sorafenib in treating advanced RCC, with patients on Inlyta living longer without disease progression.

Q: What are the financial projections for Pfizer's oncology segment, including Inlyta? A: Pfizer's oncology segment is expected to grow operationally, driven by new product launches and cost-saving initiatives, despite declines in COVID-related revenues.

Cited Sources

1. European Medicines Agency (EMA). Inlyta | European Medicines Agency (EMA).
2. Pfizer. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.
3. Transparency Market Research. Kidney Cancer Drugs Market- Global Industry Analysis 2020.
4. Pfizer. Pfizer Reports Strong Second-Quarter 2024 Results And Raises Full-Year Guidance.
5. Pfizer. INLYTA® (axitinib) Efficacy Measures | 2nd-Line | Safety Info.