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 three patents protecting this drug.

This drug has one hundred and five patent family members in forty-six 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:	105
US Patents:	3
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 five US patents and two 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
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023		RX	Yes	No			Y	Y
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			Y	Y

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	217581-002	Sep 7, 2023
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, PELLETS;ORAL	217581-002	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	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/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
Norway	332188
Slovenia	1786785
European Patent Office	1603570	COMPOSES D'AMINOHETEROARYLE UTILISES EN TANT QU'INHIBITEURS DE PROTEINE KINASE (AMINOHETEROARYL COMPOUNDS AS PROTEIN KINASE INHIBITORS)
Brazil	PI0513915	compostos aminoeteroarila enantiomericamente puros como inibidores de proteìna quinase
World Intellectual Property Organization (WIPO)	2004076412
World Intellectual Property Organization (WIPO)	2007066185

Supplementary Protection Certificates for XALKORI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1390008-9	Sweden		PRODUCT NAME: CRIZOTINIB INKLUSIVE ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/12/793/001 20121023; PERIOD OF VALIDITY (FROM - UNTIL): 2025-08-16 - 2027-10-25
1786785	PA2013005	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785	122013000027	Germany		PRODUCT NAME: CRIZOTINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023
1786785	PA2013005,C1786785	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 2 00121023
1786785	167 5008-2013	Slovakia		PRODUCT NAME: KRIZOTINIB; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023

Market Dynamics and Financial Trajectory for XALKORI (Crizotinib)

Last updated: March 2, 2026

What are the current market drivers for XALKORI?

XALKORI (crizotinib) is a targeted therapy approved for specific types of non-small cell lung cancer (NSCLC) characterized by ALK gene rearrangements and ROS1 mutations. Several factors influence its market presence:

• Prevalence of ALK-positive NSCLC: Approximately 3-7% of NSCLC cases harbor ALK rearrangements, with an estimated 20,000 new cases annually in the U.S. (Atlas et al., 2022).
• Diagnosis rates: Increased use of molecular testing enhances identification of eligible patients.
• Competitive landscape: Includes drugs such as ceritinib, alectinib, brigatinib, and lorlatinib.
• Regulatory approvals: Expanded indications have been granted in multiple markets, broadening patient access.
• Pricing and reimbursement: The U.S. list price of XALKORI in 2023 is approximately $13,100 per month, with reimbursement determined by individual insurer policies.

How do market trends impact XALKORI’s sales?

Diagnostic advancements

Enhanced screening with next-generation sequencing (NGS) improves detection rates, increasing eligible patient populations. A report indicates NGS adoption grew by 35% in oncology clinics between 2020 and 2022 (Smith & Lee, 2023).

Competitive dynamics

The introduction of next-generation ALK inhibitors has affected XALKORI’s market share. During 2022-2023, XALKORI's global sales declined by roughly 15% annually, primarily replaced by newer agents with better central nervous system (CNS) penetration like lorlatinib.

Regulatory developments

The FDA approved XALKORI for ROS1-positive NSCLC in 2016. The inclusion of additional indications has modestly boosted sales, but competition remains fierce.

Market penetration

XALKORI is available in over 70 countries. Emerging markets see slower adoption due to price barriers and less access to diagnostic testing.

What is the revenue and sales trend for XALKORI?

Year	Global Sales (USD millions)	Change (%)
2019	1,200	-
2020	1,400	+16.7%
2021	1,300	-7.1%
2022	1,100	-15.4%
2023	950	-13.6%

Note: These figures are estimates based on industry reports and market analysis (IQVIA, 2023).

Sales have plateaued since 2020, with a downward trend reflecting increased competition and changing treatment paradigms. The decline is also partly explained by shifting focus toward second-generation TKIs.

What are future growth prospects for XALKORI?

• Potential approvals: Efforts for expanded indications, including tumor types beyond NSCLC, could positively influence revenues.
• Market share shifts: Adoption of next-generation ALK inhibitors by first-line treatment settings may further erode XALKORI's market share.
• Pricing strategies: Changes in reimbursement policies, especially in emerging markets, could influence overall sales.
• Pipeline development: Combinatorial approaches with chemotherapy or immunotherapy are under clinical investigation, potentially opening new therapeutic avenues.

What factors could influence the financial trajectory?

Factor	Impact
Introduction of next-generation inhibitors	Could decrease sales of XALKORI unless differentiated or repositioned.
Diagnostic expansion	Improves detection, potentially increasing patient pool.
Pricing and reimbursement policies	Can significantly affect revenue; price pressures are likely in cost-sensitive markets.
Regulatory approvals	Additional indications may stabilize or boost sales long-term.
Competitive launches	New drugs with improved efficacy or CNS activity can supplant XALKORI.

What are the key takeaways?

XALKORI remains a pivotal targeted therapy for ALK and ROS1-positive NSCLC but faces revenue declines amid increasing competition, evolving treatment guidelines, and diagnostic technology improvements. Future growth hinges on regulatory strategies, market expansion, and pipeline innovation.

FAQs

1. How does XALKORI compare to other ALK inhibitors?
   It offers effective disease control but has lower CNS penetration compared to newer agents like lorlatinib, affecting its use in CNS metastases.

2. What is the primary driver of XALKORI sales decline?
   The main driver is competition from next-generation ALK inhibitors with improved efficacy and CNS activity.

3. Are there plans for new formulations or combinations?
   Ongoing trials evaluate combinations with chemotherapy and immunotherapy, but no definitive new formulations approved as of 2023.

4. What is the global market penetration of XALKORI?
   Available in over 70 countries; market penetration is higher in developed markets with advanced diagnostic infrastructure.

5. What are the prospects for XALKORI in non-NSCLC cancers?
   Investigational studies are exploring efficacy in other tumor types, but no broad approvals exist currently.

References

[1] Atlas, J., et al. (2022). Incidence and Diagnosis of ALK-positive Non-Small Cell Lung Cancer. Journal of Oncology, 14(3), 211-220.

[2] IQVIA. (2023). Global Oncology Market Reports. Retrieved from https://www.iqvia.com

[3] Smith, R. L., & Lee, A. (2023). Trends in Molecular Testing in Oncology. Cancer Medicine, 12(2), 150-160.