XALKORI Drug Patent Profile

When do Xalkori patents expire, and what generic alternatives are available?

Xalkori is a drug marketed by Pf Prism Cv and is included in two NDAs. There are five patents protecting this drug.

This drug has one hundred and fifty-two patent family members in forty-eight countries.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Xalkori

Xalkori was eligible for patent challenges on August 26, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 6, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XALKORI

International Patents:	152
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	51
Patent Applications:	2,855
Drug Prices:	Drug price information for XALKORI
What excipients (inactive ingredients) are in XALKORI?	XALKORI excipients list
DailyMed Link:	XALKORI at DailyMed

See drug prices for XALKORI

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

NDA:

202570

Dosage:

CAPSULE;ORAL

NDA:

217581

Dosage:

CAPSULE, PELLETS;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 XALKORI

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

Sponsor	Phase
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Zai Lab (Shanghai) Co., Ltd.	Phase 3
Bristol-Myers Squibb	Phase 3

See all XALKORI clinical trials

Pharmacology for XALKORI

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2B6 Inhibitors Cytochrome P450 3A Inhibitors Organic Cation Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors Receptor Tyrosine Kinase Inhibitors

US Patents and Regulatory Information for XALKORI

XALKORI is protected by seven US patents and three FDA Regulatory Exclusivities.

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	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No

Expired US Patents for XALKORI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023

EU/EMA Drug Approvals for XALKORI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Xalkori	crizotinib	EMEA/H/C/002489 XALKORI as monotherapy is indicated for:The first‑line treatment of adults with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with ROS1‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of paediatric patients (age ≥6 to	Authorised	no	no	no	2012-10-23

International Patents for XALKORI

When does loss-of-exclusivity occur for XALKORI?

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

Hong Kong

Israel

Japan

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 XALKORI around the world.

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2373	Enantiomerically pure aminoheteroaryl compounds asprotein kinase inhibitors.
Eurasian Patent Organization	200501236	АМИНОГЕТЕРОАРИЛЬНЫЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗ
Japan	4695588
Argentina	056832

Supplementary Protection Certificates for XALKORI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	C300587	Netherlands		PRODUCT NAME: CRIZOTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023
1786785	C 2013 011	Romania		PRODUCT NAME: CRIZOTINIB, OPTIONAL IN FORMA DE SARE ACCEPTABILAFARMACEUTIC, HIDRAT SAU SOLVAT AL ACE EU/1/12/793/004; DATE OF NATIONAL AUTHORISATION: 20121023; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/793/001, EMEA EU/1/12/793/002, EMEA EU/1/12/793/003, EMEA EU/1/12/793/004; DATE OF FIRST AUTHORISATION IN EEA: 20121023 STUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/793/001, RO EU/1/12/793/002, RO EU/1/12/793/003, RO
1786785	92155	Luxembourg		PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
1786785	C01786785/01	Switzerland		FORMER OWNER: PFIZER INC., US

Market Dynamics and Financial Trajectory for XALKORI (Crizotinib)

Introduction to XALKORI

XALKORI, also known as crizotinib, is a targeted therapy used primarily for the treatment of non-small cell lung cancer (NSCLC) that is ALK-positive or ROS1-positive. Developed by Pfizer, this drug has been a significant player in the oncology market.

Market Size and Growth

The crizotinib market is projected to grow substantially over the forecast period of 2023-2031. According to Consegic Business Intelligence, the market size is expected to reach USD 1,505.14 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.6% from its 2023 value of USD 970.48 million[1].

Application Segments

The crizotinib market is segmented into two primary application categories: ALK-positive NSCLC and ROS1-positive NSCLC. The ALK-positive NSCLC segment dominates the market, accounting for 83.79% of the market share in 2022. This segment is expected to grow at the fastest CAGR during the forecast period due to the increasing prevalence of ALK gene rearrangements in lung cancer patients[1].

Regional Market Dynamics

Geographically, the crizotinib market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America held the highest market share in 2022, valued at USD 359.26 million, with the U.S. accounting for 64.10% of this share. The growth in North America is driven by increased exposure to hazardous working environments and a preference for precision medicine and targeted therapies[1].

The Asia-Pacific region is expected to be the fastest-growing market, with a CAGR of 6.1% during the forecast period. This growth is attributed to increasing household incomes and a rising preference for advanced diagnostic procedures, leading to more frequent diagnoses of lung cancers[1].

Competitive Landscape

The crizotinib market is highly competitive, with several key players including Pfizer, Bulat Pharmaceutical, Beacon Pharmaceuticals PLC, Selleck Chemicals, and others. These companies have strong research and development capabilities and extensive product portfolios and distribution networks. The market is characterized by intense competition, with companies focusing on expanding their product offerings and market share through mergers, acquisitions, and partnerships[1].

Financial Performance of Pfizer

Pfizer, the developer of XALKORI, has seen significant financial fluctuations in recent years, largely due to the impact of COVID-19 products like Comirnaty and Paxlovid.

In 2022, Pfizer reported record full-year revenues of $100.3 billion, with a 23% increase from 2021. However, the revenues for 2023 declined to $58.5 billion, primarily due to a significant decrease in Comirnaty and Paxlovid revenues. Excluding these contributions, Pfizer's revenues grew 7% operationally in 2023[2][5].

Specific Revenue Contributions

While the detailed financial reports do not break down the revenue specifically for XALKORI, it is part of Pfizer's broader oncology portfolio. The growth in the oncology segment, excluding COVID-19 products, indicates a positive trajectory for targeted therapies like XALKORI.

Market Drivers

Several factors drive the growth of the crizotinib market:

• Increasing Prevalence of ALK-positive NSCLC: The rising incidence of ALK-positive NSCLC, particularly among younger patients who have never smoked, is a significant driver. According to the Lung Cancer Foundation of America, ALK-positive NSCLC occurs in 1 out of 25 NSCLC patients[1].
• Advances in Diagnostic Technologies: Improvements in diagnostic technologies enable more precise and rapid detection of ALK mutations, facilitating timely and appropriate treatment[4].
• Preference for Precision Medicine: The increasing preference for precision medicine and targeted therapies in regions like North America further boosts the market[1].

Market Restraints

Despite the growth, there are factors that restrain the market:

• Side Effects: Side effects associated with the consumption of crizotinib are a major factor restricting market growth. Managing these side effects is crucial for patient compliance and overall market expansion[1].

Future Projections

The crizotinib market is expected to continue growing, driven by the increasing incidence of ALK-positive cancers and advancements in cancer treatment. The Asia-Pacific region is anticipated to be a key growth area due to its rising income levels and increasing preference for advanced diagnostic procedures[1].

Key Takeaways

• The crizotinib market is projected to reach USD 1,505.14 million by 2031, growing at a CAGR of 5.6%.
• The ALK-positive NSCLC segment dominates the market and is expected to grow at the fastest CAGR.
• North America holds the highest market share, but the Asia-Pacific region is expected to be the fastest-growing.
• The market is highly competitive, with key players focusing on research and development and market expansion strategies.
• Advances in diagnostic technologies and a preference for precision medicine are significant market drivers.

FAQs

What is the primary application of XALKORI (crizotinib)?

XALKORI is primarily used for the treatment of ALK-positive and ROS1-positive non-small cell lung cancer (NSCLC).

Which region is expected to be the fastest-growing market for crizotinib?

The Asia-Pacific region is expected to be the fastest-growing market for crizotinib, driven by increasing household incomes and a rising preference for advanced diagnostic procedures.

What are the major drivers of the crizotinib market?

The major drivers include the increasing prevalence of ALK-positive NSCLC, advances in diagnostic technologies, and a preference for precision medicine and targeted therapies.

Who are the key players in the crizotinib market?

Key players include Pfizer, Bulat Pharmaceutical, Beacon Pharmaceuticals PLC, Selleck Chemicals, and several other pharmaceutical companies.

What are the potential restraints to the growth of the crizotinib market?

Side effects associated with the consumption of crizotinib are a significant restraint to market growth.

Sources

1. Consegic Business Intelligence - Crizotinib Market Size, Share, Manufacturers | Technology 2031
2. Pfizer - Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance
3. Reuters - Insight: Cancer drugs proving worth in earlier testing
4. DelveInsight - ALK Inhibitors Market: A Comprehensive Overview of Current Trends and Future Projections
5. Pfizer - Pfizer Reports Record Full-Year 2022 Results and Provides Full-Year 2023 Revenue Guidance