Crizotinib - Generic Drug Details

What are the generic drug sources for crizotinib and what is the scope of patent protection?

Crizotinib is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crizotinib has one hundred and five patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for crizotinib

International Patents:	105
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	170
What excipients (inactive ingredients) are in crizotinib?	crizotinib excipients list
DailyMed Link:	crizotinib at DailyMed

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

Constraining patent/regulatory exclusivity:

8,217,057

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

8,217,057

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 crizotinib

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

Sponsor	Phase
Tang-Du Hospital	PHASE1
Intergroupe Francophone de Cancerologie Thoracique	PHASE3
Guangdong Association of Clinical Trials	PHASE3

See all crizotinib clinical trials

Pharmacology for crizotinib

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

Anatomical Therapeutic Chemical (ATC) Classes for crizotinib

L01ED	Anaplastic lymphoma kinase (ALK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for crizotinib

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, PELLETS;ORAL	217581-002	Sep 7, 2023		RX	Yes	No	7,858,643		Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes	7,858,643		Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No	7,858,643		Y	Y

Expired US Patents for crizotinib

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	8,785,632
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023	7,230,098
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023	7,230,098

EU/EMA Drug Approvals for crizotinib

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 crizotinib

Country	Patent Number	Title	Estimated Expiration
Uruguay	29081	COMPUESTOS DE AMINOHETEROARILO ENANTIOMÉRICAMENTE PUROS COMO INHIBIDORES DE PROTEÍNA QUINASA
Brazil	PI0513915	compostos aminoeteroarila enantiomericamente puros como inibidores de proteìna quinase
Slovenia	1786785

Supplementary Protection Certificates for crizotinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	PA2013005,C1786785	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 2 00121023
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	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

Market Dynamics and Financial Trajectory for Crizotinib

Last updated: March 4, 2026

What are the current market drivers for Crizotinib?

Crizotinib is a tyrosine kinase inhibitor approved primarily for non-small cell lung cancer (NSCLC) with ALK or ROS1 gene rearrangements. Market drivers include:

• Targeted therapy demand: Rising incidence of ALK-positive NSCLC pushes demand.
• Diagnostic advancements: Improved ALK/ROS1 testing increases identified patient populations.
• Competitive landscape: Limited first-line treatment options for specific gene rearrangements bolster Crizotinib's market share.
• Regulatory approvals: Expanded indications in multiple jurisdictions, including China and the EU, sustain growth.
• Pipeline developments: Prescriptions are influenced by ongoing clinical trials exploring combination therapies and new indications.

How does the competitive environment impact Crizotinib's market?

Crizotinib faces competition from newer agents:

• Alectinib: Approved as a first-line treatment; shows superior efficacy and CNS penetration.
• Lorlatinib: Offers enhanced brain metastasis control; approved for ALK-positive advanced NSCLC.
• Ensartinib and Brigatinib: Emerging therapies with favorable profiles.
• Generic potential: Patent expirations could lead to price erosion, though current exclusivity extends until late 2020s or early 2030s depending on jurisdiction.

What is the revenue forecast for Crizotinib?

Based on market research reports, the global NSCLC market is projected to grow from USD 15 billion in 2022 to USD 25 billion by 2030, with targeted therapies accounting for a rising share.

Year	Estimated Revenue (USD billion)	Notes
2022	1.8	Crizotinib's contribution (~12%), estimated from market size
2025	2.2	Market expansion, increased adoption
2030	3.0	Competition with newer agents, but steady demand

Crizotinib's sales are expected to reach approximately USD 1.5–2 billion annually by 2025, declining after the introduction of competitors.

How will regulatory and pipeline events influence the outlook?

• Regulatory actions: Additional approvals for new indications could sustain or increase sales.
• Pipeline data: Successful trials for first-line use and in other cancers (e.g., solid tumors with MET alterations) may open new markets.
• Patent status: Anticipated patent cliff around 2024–2026 risks generic competition, impacting revenue.

What are the key risks to the financial trajectory?

• Market saturation: Competition from more effective or convenient therapies reduces market share.
• Pricing pressures: Price negotiations, especially in cost-sensitive markets, can limit profit margins.
• Regulatory hurdles: Delays or denials for new indications can slow growth.
• Pipeline failures: Lack of approvals for extended indications or combination therapies diminishes long-term potential.

Summary

Crizotinib remains a significant player in targeted NSCLC therapy but faces substitution pressures from next-generation TKIs. Its revenue is expected to grow modestly until patent expiry, after which generic competition may reduce its market share and earnings.

Key Takeaways

• The global NSCLC targeted therapy market is expanding, but Crizotinib's shares are challenged by newer agents such as Alectinib.
• Revenue projections indicate growth until mid-2020s, followed by decline due to patent expiration and competition.
• Regulatory decisions and pipeline developments could alter the outlook positively.
• Market risks include competitive pressures, pricing models, and potential pipeline failures.
• Strategic planning for patent protections and pipeline expansion is essential for revenue preservation.

5 FAQs

1. When does Crizotinib's patent expiration typically occur?
Predominantly around 2024–2026, varying by jurisdiction.

2. Which competitors pose the greatest threat to Crizotinib?
Alectinib and Lorlatinib are the primary competitors for first-line and CNS-treated cases.

3. Are there ongoing trials to expand Crizotinib’s indications?
Yes, trials are exploring new combinations, earlier treatment lines, and additional tumor types.

4. How does cost-effectiveness influence Crizotinib's market?
Pricing negotiations and reimbursement policies significantly impact sales, especially in Europe and Asia.

5. What strategies can extend Crizotinib’s market viability?
Focusing on combination therapies, securing regulatory approvals for new indications, and patent extensions are key.

---

References

[1] Market Research Future. (2022). NSCLC market outlook. https://www.marketresearchfuture.com/reports/non-small-cell-lung-cancer-market-2347
[2] Evaluate Pharma. (2022). World Preview 2022, Outlook to 2027. https://www.evaluate.com/thought-leadership/market-access/world-preview-2022
[3] Food and Drug Administration. (2021). Crizotinib approval updates. https://www.fda.gov/drugs/resources-information-approved-drugs/crizotinib