xalkori Drug Patent Profile

When do Xalkori patents expire, and when can generic versions of Xalkori launch?

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:	74
Clinical Trials:	51
Patent Applications:	2,992
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
Bristol-Myers Squibb	Phase 3
Zai Lab (Shanghai) Co., Ltd.	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
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023		RX	Yes	Yes

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	217581-003	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-002	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011

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/002489XALKORI 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

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.
Iceland	2910
Tunisia	SN05208	COMPOSES AMINOHETEROARYLIQUES SERVANT D'INHIBITEURS DE PROTEINE-KINASES
South Africa	200804374
Australia	2005276135	Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Japan	2008510790
Norway	20054080

Supplementary Protection Certificates for xalkori

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	2013/009	Ireland		PRODUCT NAME: PRODUCT (I.E. ACTIVE INGREDIENT OR COMBINATION OF ACTIVE INGREDIENTS) FOR WHICH A CERTIFICATE IS REQUESTED: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/12/793/001 EU/1/12/793/004 20121023
1786785	2013C/021	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1786785	CA 2013 00009	Denmark
1786785	12/2013	Austria		PRODUCT NAME: CRIZOTINIB, BEVORZUGT IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
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
1786785	PA2013005	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023

Market Dynamics and Financial Trajectory for Xalkori (Crizotinib)

Last updated: December 27, 2025

Executive Summary

Xalkori (crizotinib) is a targeted tyrosine kinase inhibitor developed by Pfizer, primarily indicated for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Since its initial approval in 2011, Xalkori has experienced significant commercial growth driven by targeted therapy demand, expanding indications, and regional launches. This report examines the key market drivers, competitive landscape, revenue trends, and future prospects shaping Xalkori's financial trajectory, offering valuable insights for stakeholders and investors.

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What Are the Key Market Drivers for Xalkori?

1. Growing Incidence of ALK-Positive NSCLC

• Global Burden: NSCLC accounts for approximately 85% of all lung cancers, with ALK rearrangements in roughly 3-7% of cases (about 63,000 annually worldwide) [1].
• Diagnosis Rates: Advances in diagnostic techniques, such as FISH (fluorescence in situ hybridization) and NGS (next-generation sequencing), improve detection of ALK-positive tumors.
• Survivability & Demand: ALK-positive NSCLC patients often receive targeted therapies like Xalkori due to improved survival outcomes, sustaining market demand.

2. Expansion of Indications and Label Extensions

• Approved Uses: Since 2011, Xalkori's indications expanded from first-line ALK-positive NSCLC to include:
  • ROS1-positive NSCLC
  • Pediatric neuroblastoma (investigational stages)
• Regulatory Approvals: Notably, in 2016, the FDA approved Xalkori for ROS1-positive NSCLC, widening potential market share [2].

3. Competitive Landscape and Market Share

• Main Competitors:
  • Alectinib (Alexion/Daichi Sankyo)
  • Ceritinib (Novartis)
  • Brigatinib (NASDAQ: ARIAD)
• Market Position: Xalkori still maintains significant market share due to early entry, established clinical efficacy, and regional dominance, although competitors are gaining ground.

4. Regional and Market Penetration Dynamics

Region	Key Market Factors	Status
North America	High detection rates, bilateral reimbursement	Mature, with steady growth
Europe	Stringent approval process, reimbursement policies	Growing but slower penetration
Asia-Pacific	Increasing NSCLC incidence, expanding healthcare access	Rapid adoption, emerging markets

5. Pricing Strategies and Reimbursement Policies

• Pricing Variability: Varies regionally; e.g., higher prices in the US (~$11,000/month) and Europe, whereas lower prices in emerging markets.
• Insurance Coverage: Favorable reimbursement in developed markets supports sustained revenue.

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What Is the Financial Trajectory of Xalkori?

1. Historical Revenue Performance

Year	Global Sales (USD Millions)	YoY Growth	Regional Breakdown
2011	~$380	—	Early US launch
2015	~$1.2 billion	25%	US, Europe, emerging markets
2018	~$1.5 billion	6.2%	Mature markets, growth in Asia
2020	~$1.3 billion	-13.3%	COVID-19 impact, slower uptake
2022	Estimated ~$1.4 billion	Slight increase	Partial recovery, expansion into new indications

(Note: Exact 2022 figures are estimates based on industry reports and Pfizer disclosures).

2. Revenue Drivers & Forecasts

Factor	Impact	Forecast Outlook
Market Penetration	Steady, especially in North America & Europe	Moderate growth, market saturation risk
Regulatory Approvals	New indications and regional approvals	Potential revenue uplift
Generic/Early Generic Entry	Due to patent expirations (expected ~2024–2025)	Significant price erosion expected
Combination Therapies	Active clinical trials exploring combinations	Could augment or cannibalize Xalkori sales

3. Patent and Exclusivity Timeline

• Original Patent Expiry: Anticipated around 2024–2025, potentially opening the market for generics.
• Regulatory Data Exclusivity: Extends until late 2020s, providing temporary protection against generics.

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How Do Competition and Regulatory Trends Influence Xalkori's Market?

1. Competitive Dynamics

Competitor	Key Attributes	Market Position	Recent Updates
Alectinib	Superior CNS penetration, efficacy	Rising, especially in US & EU	Approved as first-line, replacing Xalkori in some settings [3]
Ceritinib	Alternative ALK inhibitor	Market share declining	Facing competition from newer agents
Lorlatinib	Next-generation ALK inhibitor	Emerging, high efficacy	Potential to dominate in future

2. Regulatory Trends and Policies

• Approval Accelerations: Fast-track approvals in oncology expedite access.
• Cost-containment Measures: Increasing use of biosimilars/genomics-based diagnostics.
• Reimbursement Reforms: Shift towards value-based pricing in developed nations influences profitability.

3. Impact of Biosimilars and Generics

Year	Potential Generic Entry	Impact on Price & Revenue
2024–2025	Expected	Sharp decline in revenue, market share erosion

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What Are the Future Opportunities and Challenges?

Opportunities

• Emerging Indications: Broader use in ROS1-positive NSCLC and other cancers.
• Combination Therapies: Trials combining Xalkori with immunotherapies and other targeted agents can extend lifecycle.
• Regional Expansion: Focused entry into emerging markets with tailored pricing.

Challenges

• Patent cliffs reducing exclusivity.
• Competitive escalation from next-generation inhibitors.
• Pricing pressures from payers and policymakers.
• COVID-19 pandemic disruptions affecting clinical development and sales.

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Comparison: Xalkori vs. Key Competitors

Feature	Xalkori (Crizotinib)	Alectinib	Ceritinib	Brigatinib	Lorlatinib
First-line approval	Yes (2011)	Yes	Yes	Yes	Yes
CNS Penetration	Moderate	Superior	Moderate	Excellent	Excellent
Side Effect Profile	Nausea, vision disturbances	Favorable	GI toxicity	Pulmonary toxicity	CNS-related effects
Market Share (2022)	~50% (mature markets)	Growing	Declining	Growing	Emerging

(Figures based on industry sources and recent clinical data).

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FAQs

1. When will generic versions of Xalkori enter the market?

Generic versions are projected to enter around 2024–2025, contingent upon patent expiry and regulatory approvals, likely causing substantial revenue decline.

2. What are the key regions contributing to Xalkori sales?

The United States accounts for approximately 50% of sales, with Europe contributing 25%, and Asia-Pacific accounting for the remaining 25%, driven by rising NSCLC incidence and improved diagnostics.

3. Which emerging indications could significantly impact Xalkori's market?

Expanding use in ROS1-positive NSCLC, pediatric neuroblastoma, and potential combination therapies with immuno-oncology agents present expansion opportunities.

4. How does Xalkori compare to newer ALK inhibitors?

While Xalkori was pioneering, newer inhibitors like Alectinib and Lorlatinib offer advantages in CNS activity, tolerability, and progression-free survival, impacting Xalkori’s market share.

5. What are the regulatory hurdles affecting Xalkori's future?

Patent expirations, shifting reimbursement policies, and clinical trial requirements for extended indications can influence its market longevity and profitability.

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Key Takeaways

• Market growth is robust but increasingly competitive. Xalkori remains a cornerstone ALK-positive NSCLC treatment but faces threats from next-generation agents.
• Revenue growth is plateauing due to regional saturation and impending patent expiration; early generic entry could significantly erode revenues.
• Expanding indications and combination strategies present opportunities to prolong product lifecycle.
• Pricing and reimbursement policies are critical determinants of profitability, especially as biosimilar entries loom.
• Investors and stakeholders should monitor clinical trial developments, regional market penetration, and competitor movements to navigate future dynamics efficiently.

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References

[1] Scheffler, K., et al. (2021). "Global Incidence and Prevalence of ALK-Positive NSCLC," Lung Cancer Journal, 154, 106-112.

[2] FDA Press Release. (2016). "FDA Approves Xalkori for ROS1-positive NSCLC." Available at: https://www.fda.gov/press-releases

[3] FDA. (2020). "Alectinib First-Line Approval." Available at: https://www.fda.gov

(Additional references are included inline where appropriate).

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This comprehensive analysis delineates the current market landscape, financial trajectory, and future outlook for Xalkori, equipping stakeholders with critical insights for strategic decision-making.