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 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:	155
Patent Applications:	339
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
Hunan Province Tumor Hospital	Phase 1/Phase 2
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3
Zai Lab (Shanghai) Co., Ltd.	Phase 3

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;ORAL	202570-001	Aug 26, 2011		RX	Yes	No	7,230,098			Y
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, PELLETS;ORAL	217581-001	Sep 7, 2023		RX	Yes	No	8,217,057			Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes

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;ORAL	202570-001	Aug 26, 2011	8,785,632
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-001	Sep 7, 2023	8,785,632
Pf Prism Cv	XALKORI	crizotinib	CAPSULE, PELLETS;ORAL	217581-003	Sep 7, 2023	8,785,632

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/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 crizotinib

Country	Patent Number	Title	Estimated Expiration
Portugal	2476667
Serbia	51362	ENANTIOMERNO ČISTA AMINOHETEROARIL JEDINJENJA KAO INHIBITORI PROTEIN KINAZA (ENANTIOMERICALLY PURE AMINOHETEROARYL COMPUNDS AS PROTEIN KINASE INHIBITORS)
New Zealand	568654	Method of treating abnormal cell growth
Brazil	PI0619420	bases livres de polimorfos de um inibidor de c-met/hgfr, bem como uso das mesmas, composição farmacêutica, cápsula e uso da mesma

Supplementary Protection Certificates for crizotinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	13C0015	France		PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121026
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	CA 2013 00009	Denmark

Market Dynamics and Financial Trajectory for Crizotinib

Introduction to Crizotinib

Crizotinib is a targeted therapy used primarily in the treatment of non-small cell lung cancer (NSCLC) with specific genetic mutations, such as ALK (anaplastic lymphoma kinase) and ROS1 positive NSCLC. Here, we delve into the market dynamics and financial trajectory of crizotinib, highlighting its growth prospects, challenges, and key market trends.

Market Size and Growth Projections

The global crizotinib market is experiencing significant growth. As of 2022, the market size was valued at USD 923.08 million, and it is projected to reach USD 1,505.14 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period (2023-2031)[1].

Regional Market Performance

North America

North America, particularly the United States, holds a substantial share of the crizotinib market. In 2022, North America accounted for 38.92% of the market share, valued at USD 359.26 million. The U.S. alone accounted for 64.10% of this regional share. The growth in this region is driven by increased exposure to hazardous working environments and a preference for precision medicine and targeted therapies[1].

Asia Pacific

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

Key Drivers of Market Growth

Increasing Prevalence of Lung Cancer

Lung cancer, especially NSCLC, is highly prevalent globally, accounting for 1 in 5 cancer-related deaths. This high prevalence drives the demand for effective treatments like crizotinib[4].

Advances in Precision Medicine

The growing understanding and application of precision medicine, which involves targeted therapies based on genetic mutations, significantly boosts the demand for crizotinib. Genetic testing helps identify more patients who can benefit from this treatment, driving market growth[4].

Government Health Campaigns and Patient Assistance Programs

Government-led health campaigns against smoking and tobacco consumption, along with patient assistance programs and reimbursement initiatives, help reduce the cost of the drug and encourage more patients to undergo treatment[4].

Market Challenges

Side Effects and Patient Adherence

One of the major factors restricting the growth of the crizotinib market is the side effects associated with its consumption. These side effects can affect patient adherence to treatment, posing a challenge to market expansion[1].

Emergence of Alternative Therapies

The emergence of alternative targeted therapies or treatments for the same genetic mutations could provide competitive alternatives for patients, potentially affecting the demand for crizotinib. Regulatory obstacles and high development costs also present difficulties for market expansion[4].

Cost-Effectiveness and Economic Analysis

Comparative Cost-Effectiveness

Studies have compared the cost-effectiveness of crizotinib with other ALK inhibitors like ensartinib, ceritinib, and brigatinib. For instance, ensartinib achieved additional quality-adjusted life-years (QALYs) compared to crizotinib with marginal increased costs, resulting in an incremental cost-effectiveness ratio (ICER) of $27,553/QALY. This indicates that ensartinib can be a cost-effective option compared to crizotinib under certain thresholds[5].

Treatment Costs and Utilities

The total cost associated with crizotinib includes drug acquisition, management of adverse events (AEs), routine follow-ups, and subsequent anticancer therapies. The cost of crizotinib is relatively lower compared to some other ALK inhibitors, making it a viable option for many patients[5].

Competitive Landscape

The crizotinib market is highly competitive, with several large players and numerous small and medium-sized enterprises. Key players include Pfizer, Beacon Pharma, Incepta Pharmaceuticals, and Takeda Pharmaceutical Co. Ltd. These companies have strong research and development capabilities and a strong market presence through their extensive product portfolios and distribution networks. The market is characterized by intense competition, with companies focusing on expanding their product offerings and increasing their market share through mergers, acquisitions, and partnerships[1][4].

Product Segmentation

The crizotinib market is segmented based on the dosage form, with the 250mg capsule segment accounting for the highest market share in 2022. The market is also segmented by application, including ALK-positive NSCLC, ROS1-positive NSCLC, and other types of cancers[1][4].

Future Prospects and Opportunities

Growing Understanding of Genetic Mutations

The increasing understanding of genetic mutations that lead to certain types of cancer presents a significant opportunity for the crizotinib market. As healthcare systems worldwide focus on personalized treatment methods, the demand for targeted therapies like crizotinib is likely to continue growing[4].

Ongoing Research and Trials

Ongoing research and clinical trials testing new ways to use crizotinib also contribute to its popularity and potential for broader applications. This continuous innovation could broaden its uses and enhance treatment outcomes for a wider range of cancer patients[4].

Key Takeaways

• The global crizotinib market is projected to reach USD 1,505.14 million by 2031, growing at a CAGR of 5.6%.
• North America and the Asia Pacific are key regions driving market growth.
• The market is driven by the increasing prevalence of lung cancer, advances in precision medicine, and government health campaigns.
• Side effects and the emergence of alternative therapies are significant challenges.
• Crizotinib remains a cost-effective option compared to some other ALK inhibitors.
• The market is highly competitive, with key players focusing on expanding their product offerings.

FAQs

Q: What is the projected market size of crizotinib by 2031? A: The crizotinib market is expected to reach USD 1,505.14 million by 2031[1].

Q: Which region is expected to grow the fastest in the crizotinib market? A: The Asia Pacific region is expected to be the fastest-growing region in the crizotinib market during the forecast period[1].

Q: What are the main drivers of the crizotinib market growth? A: The main drivers include the increasing prevalence of lung cancer, advances in precision medicine, and government health campaigns against smoking and tobacco consumption[4].

Q: What are the significant challenges facing the crizotinib market? A: The significant challenges include side effects associated with the drug, the emergence of alternative targeted therapies, and regulatory obstacles[1][4].

Q: How does crizotinib compare in terms of cost-effectiveness with other ALK inhibitors? A: Crizotinib is often compared to other ALK inhibitors like ensartinib, and while it may not offer additional QALYs in some cases, it remains a cost-effective option under certain thresholds[5].

Sources

1. Consegic Business Intelligence: Crizotinib Market Size, Share, Manufacturers | Technology 2031[1]
2. Frontiers in Public Health: Cost-effectiveness of ensartinib, crizotinib, ceritinib, alectinib[2]
3. DataIntelo: Global Metastatic Ovarian Cancer Drug Sales Market[3]
4. Reports and Data: Global Crizotinib Market Share & Analysis[4]
5. Frontiers in Public Health: Cost-effectiveness of ensartinib, crizotinib, ceritinib, alectinib[5]