CRIZOTINIB - Generic Drug Details

What are the generic sources for crizotinib and what is the scope of freedom to operate?

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

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

One supplier is listed for this compound.

Summary for CRIZOTINIB

International Patents:	152
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	169
What excipients (inactive ingredients) are in CRIZOTINIB?	CRIZOTINIB excipients list
DailyMed Link:	CRIZOTINIB at DailyMed

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

Dosage:

CAPSULE;ORAL

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
Intergroupe Francophone de Cancerologie Thoracique	PHASE3
Guangdong Association of Clinical Trials	PHASE3
Fujian Medical University Union Hospital	PHASE4

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	217581-001	Sep 7, 2023		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023		RX	Yes	Yes				Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No

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
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023

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
Netherlands	1029799	Enantiomeer zuivere aminoheteroarylverbindingen als proteïnekinaseremmers.
Portugal	2476667
Argentina	050788	COMPUESTOS DE AMINOHETEROARILO ENANTIOMERICAMENTE PUROS COMO INHIBIDORES DE PROTEINA QUINASA

Supplementary Protection Certificates for CRIZOTINIB

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	CA 2013 00009	Denmark
1786785	PA2013005,C1786785	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 2 00121023

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Crizotinib

Last updated: July 27, 2025

---

Introduction

Crizotinib, marketed under brand names such as Xalkori, is a targeted therapy developed for specific genetic alterations in non-small cell lung cancer (NSCLC). Since its FDA approval in 2011, crizotinib has distinguished itself as a pivotal agent in precision oncology, driven by advances in molecular diagnostics and a growing understanding of oncogenic drivers. This analysis examines the evolving market landscape, financial performance, competitive positioning, and future prospects of crizotinib within the global oncology pharmaceutical domain.

---

Market Overview and Key Drivers

Therapeutic Indications and Patient Demographics

Crizotinib primarily serves patients with anaplastic lymphoma kinase (ALK) gene rearrangements or ROS1-positive NSCLC, which constitute approximately 3-7% of all NSCLC cases [1]. The prevalence of ALK-positive NSCLC varies globally, with higher incidences observed among never-smokers and younger patients. The therapeutic landscape has expanded to include broader genomic targeting, increasing the potential patient pool.

Growth of Molecular Diagnostics

The proliferation of molecular diagnostics has been instrumental in identifying eligible patients, a crucial determinant for crizotinib's market penetration. Companion diagnostic tests such as the Vysis ALK Break Apart FISH probe kit facilitate rapid and accurate detection of ALK rearrangements, enabling personalized treatment pathways.

Competitive and Developmental Landscape

Crizotinib's initial success prompted the emergence of next-generation ALK inhibitors, including alectinib, brigatinib, and lorlatinib, which offer improved efficacy and safety profiles. The competitive landscape influences market share dynamics, pricing strategies, and growth potential of crizotinib.

Regulatory and Reimbursement Policies

Regulatory approvals across North America, Europe, and Asia-Pacific underpin market access. Reimbursement policies, particularly in cost-sensitive markets like China and India, impact adoption rates and sales volumes.

---

Financial Trajectory Analysis

Sales Performance and Revenue Trends

Crizotinib achieved peak global sales of approximately $850 million in 2015, driven by robust uptake in North America and Europe [2]. Post-2015, sales plateaued due to the competitive pressure from second-generation ALK inhibitors. However, recent data indicates a slight resurgence in markets prioritizing earlier-line therapy, supported by expanded indications.

Revenue Decline and Growth Factors

• Market Penetration: As newer agents gain approval, crizotinib’s market share in first-line settings has diminished but remains significant in regions with limited access to next-gen drugs.
• Pricing Dynamics: Initial high pricing strategies, often $9,000 to $12,000 per month, faced pressures from payers and healthcare systems seeking cost-effective alternatives.
• Generic Entry: Patent expiration prospects and biosimilar development could further influence revenue streams, although as of now, crizotinib’s patents remain active in key markets.

Investment and R&D Expenditures

Major pharmaceutical companies, notably Pfizer (original developer) and later, its licensees, have invested in clinical trials exploring crizotinib’s expanded indications, including ROS1-positive NSCLC and pediatric tumors. These investments aim to sustain relevance amid evolving standards of care.

---

Market Share and Competitive Positioning

Positioning Against Next-Generation ALK Inhibitors

• Alectinib and Brigatinib: These agents offer superior central nervous system (CNS) penetration and mutation coverage, leading to increased adoption.
• Loritibam: Approved as a subsequent-line therapy, Lorlatinib has further edged out crizotinib in certain indications.

Despite these advances, crizotinib retains a foothold, particularly as a first-line agent in regions where access to newer drugs is limited. Its role persists as a cost-effective, initial-choice therapy contingent upon healthcare infrastructure.

Strategic Collaborations and Licensing

Partnerships with diagnostic firms and regional pharmaceutical companies bolster crizotinib’s market reach. Strategic licensing arrangements facilitate distribution in emerging markets, offsetting stagnating sales in mature markets.

---

Future Market Trends and Opportunities

Expansion of Indications

Research ongoing in clinical trials expands crizotinib's use to include ROS1-positive NSCLC and potential efficacy in other solid tumors. This diversification enhances the drug's market viability.

Combination Therapies

Synergistic combinations with immune checkpoint inhibitors and other targeted agents are under exploration, with the goal of overcoming resistance mechanisms and improving patient outcomes.

Market Expansion in Developing Countries

Increasing healthcare infrastructure and diagnostics deployment in Asia-Pacific and Africa present growth avenues. Price adjustments and biosimilar entry can catalyze broader access.

Regulatory and Patent Outlook

Patent expirations anticipated around 2024-2027 could trigger generic entry, substantially reducing costs and altering the financial trajectory. Companies are proactively developing next-generation formulations and indications to mitigate revenue loss.

---

Challenges and Risks

• Competitive Threats: The rapid evolution of ALK inhibitors underscores the need for continuous innovation.
• Resistance Development: Acquired resistance limits long-term efficacy, necessitating regimen adjustments.
• Cost and Reimbursement Pressures: Rising scrutiny over drug costs may constrain sales, especially in price-sensitive markets.
• Regulatory Hurdles: Delays in expanding indications or acquiring approvals can hinder market growth.

---

Key Takeaways

• Crizotinib’s market dominance has diminished with the advent of more effective second- and third-generation ALK inhibitors but remains relevant in specific markets and indications.
• Revenue growth has plateaued due to competitive erosion, patent expiration, and evolving treatment guidelines, though opportunities remain in expanding indications and geographies.
• Strategic collaborations and ongoing clinical research are vital for maintaining competitive positioning and extending product lifecycle.
• Emerging biosimilars and generics pose a significant future threat, emphasizing the importance of innovation, patent protections, and lifecycle management.
• Market success hinges on addressing resistance mechanisms, expanding efficacy profiles, and ensuring health economic value in diverse healthcare settings.

---

Conclusion

Crizotinib epitomizes the transformative power of targeted therapy in oncology, with a dynamic market trajectory shaped by scientific innovation, regulatory frameworks, and socioeconomic factors. Its future hinges on strategic adaptation to competitive pressures, ongoing clinical excellence, and global access initiatives, ensuring relevance in the rapidly evolving oncology treatment paradigm.

---

FAQs

1. What are the main indications for crizotinib?
Crizotinib is primarily indicated for ALK-positive and ROS1-positive non-small cell lung cancer (NSCLC), representing a subset of lung cancers with specific genetic alterations.

2. How does crizotinib compare to next-generation ALK inhibitors?
While crizotinib was pioneering, second-generation agents such as alectinib and brigatinib offer improved CNS penetration, efficacy, and resistance profiles, often leading to their preference in clinical practice.

3. What is the projected impact of patent expiries on crizotinib’s market?
Patent expiries around 2024-2027 are expected to open the market to biosimilars and generics, potentially leading to a substantial decline in revenue unless new indications or formulations are developed.

4. Are there ongoing efforts to expand crizotinib’s clinical applications?
Yes. Clinical trials are exploring its utility in ROS1-positive tumors beyond lung cancer, pediatric cancers, and combination regimens to extend its therapeutic landscape.

5. How do regional healthcare policies influence crizotinib’s market performance?
In markets with favorable reimbursement and robust diagnostic infrastructure, crizotinib’s adoption is higher. Conversely, cost-containment policies and limited diagnostics hinder market penetration in emerging economies.

---

References

[1] National Cancer Institute. "NSCLC Molecular Testing."
[2] EvaluatePharma. "Pharmaceutical Sales Data 2015."