Ceritinib - Generic Drug Details

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

Ceritinib is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ceritinib has two hundred and eighty-six patent family members in fifty-four countries.

There is one drug master file entry for ceritinib. One supplier is listed for this compound.

Summary for ceritinib

International Patents:	286
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	37
Patent Applications:	2,118
What excipients (inactive ingredients) are in ceritinib?	ceritinib excipients list
DailyMed Link:	ceritinib at DailyMed

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

Constraining patent/regulatory exclusivity:

9,309,229

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

9,309,229

Dosage:

TABLET;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 ceritinib

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 2
Nuvalent Inc.	Phase 1/Phase 2
Pfizer	Phase 4

See all ceritinib clinical trials

Pharmacology for ceritinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ceritinib

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

US Patents and Regulatory Information for ceritinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	9,309,229		Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	7,964,592		Y	Y
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	8,399,450		Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	8,399,450		Y	Y
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	9,309,229		Y	Y
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	8,377,921

Expired US Patents for ceritinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	9,416,112
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	9,018,204
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	8,188,276
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	9,416,112
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	7,153,964
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	8,835,430

EU/EMA Drug Approvals for ceritinib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Zykadia	ceritinib	EMEA/H/C/003819 Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.	Authorised	no	no	no	2015-05-06

International Patents for ceritinib

Country	Patent Number	Title	Estimated Expiration
Poland	3121171
Poland	2651918
Taiwan	201124402	Compounds and compositions as protein kinase inhibitors
Portugal	2651918
Spain	2643016
Portugal	3121171

Supplementary Protection Certificates for ceritinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091918	PA2015034,C2091918	Lithuania		PRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918	300763	Netherlands		PRODUCT NAME: CERITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	PA2015034	Lithuania		PRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918	54/2015	Austria		PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508
1272477	CR 2015 00050	Denmark		PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
1272477	2015/049	Ireland		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506

Ceritinib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ceritinib

Market Overview

Ceritinib, marketed under the brand name Zykadia, is a tyrosine kinase inhibitor specifically designed to target the anaplastic lymphoma kinase (ALK) protein, which is often mutated in non-small cell lung cancer (NSCLC). The market for ceritinib is driven by several key factors that are shaping its growth and financial trajectory.

Growth Drivers

Increasing Prevalence of ALK-Positive NSCLC

The growing prevalence of ALK-positive NSCLC is a primary driver of the ceritinib market. This specific type of cancer requires targeted treatments, and ceritinib's efficacy in inhibiting the ALK protein makes it a preferred option for patients who have not responded to other treatments like crizotinib or are unable to take them orally[1].

Advancements in Precision Medicine

The advancement in precision medicine has significantly boosted the adoption of ceritinib. Precision medicine approaches allow for targeted therapy, making ceritinib a feasible first-line treatment option for ALK-positive patients[1].

Regulatory Approvals and Reimbursement Policies

Regulatory approvals and favorable reimbursement policies have facilitated the adoption of ceritinib. Early access to innovative therapies, especially in regions like North America, has been a crucial factor in the market's growth[1].

Clinical Trial Successes

Successful clinical trial results demonstrating the effectiveness of ceritinib have further propelled its market growth. For instance, studies have shown that ceritinib is a cost-effective option compared to other ALK inhibitors like crizotinib and alectinib[2].

Market Segmentation

By Indication

The ceritinib market is segmented into first-line and second-line treatments. The first-line treatment segment dominates the market, accounting for around 67% of the global ceritinib market in 2024. This is due to the increasing use of precision medicine approaches and the efficacy of ceritinib as a targeted therapy[1].

By Distribution Channel

The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a significant segment, given the nature of the treatment and the need for close medical supervision[1].

By Region

Geographically, the ceritinib market is led by North America, which accounts for more than 48% of the market share. This is attributed to the high incidence of ALK-positive NSCLC and the robust healthcare system in the region. Europe and the Asia Pacific are also significant markets, with the latter expected to be the fastest-growing regional segment due to a growing patient population and improving healthcare infrastructure[1].

Financial Trajectory

Market Size and Forecast

The ceritinib market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034, reaching a significant market size by the end of the forecast period. In 2024, the market is estimated to be valued at USD millions, with a forecasted growth driven by the increasing demand for targeted therapies[1].

Revenue Growth

The global cancer ALK inhibitor market, which includes ceritinib, is estimated to grow from USD 1.5 billion in 2020 to USD 10.6 billion by 2030, registering a CAGR of 22.0%. This robust growth is indicative of the financial trajectory of ceritinib, which is expected to contribute significantly to this market[3].

Cost-Effectiveness

Studies have shown that ceritinib is a cost-effective option compared to other ALK inhibitors. For instance, a study in the Chinese healthcare setting found that ceritinib yielded an additional 1.09 quality-adjusted life years (QALYs) with an incremental cost of $15,165, resulting in a favorable incremental cost-effectiveness ratio (ICER)[2].

Competitive Landscape

The ceritinib market is dominated by a few large pharmaceutical companies, including Novartis, the primary manufacturer of ceritinib. Other key players in the global cancer ALK inhibitor market include AstraZeneca, F. Hoffmann-La Roche, and Pfizer, among others. These companies are continuously innovating and expanding their product portfolios to capture a larger share of the market[3].

Regional Analysis

North America

North America is the leading market for ceritinib, driven by the high incidence of ALK-positive NSCLC and a robust healthcare system. The region's regulatory environment, particularly the rapid drug approval processes by the FDA, also supports the market's growth[1].

Europe

Europe's ceritinib market is growing due to the increasing use of precision medicine methods, favorable reimbursement practices, and a strong emphasis on clinical research and development. This region provides patients with greater access to targeted treatments for ALK-positive NSCLC[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Factors such as a growing patient population, rising healthcare costs, better access to cutting-edge medicines through government programs, and an expanding healthcare infrastructure drive the demand for ceritinib in this region[1].

Challenges and Restraints

Adverse Effects

Ceritinib is associated with adverse effects such as fatigue, increased liver enzymes, and gastrointestinal upset, which require continuous medical management. These side effects can impact patient compliance and overall market growth[1].

Competition from Other ALK Inhibitors

The market for ceritinib faces competition from other ALK inhibitors like crizotinib, alectinib, brigatinib, and lorlatinib. The choice of treatment often depends on the patient's response to these drugs and the specific clinical scenario[3].

Key Takeaways

• The ceritinib market is driven by the increasing prevalence of ALK-positive NSCLC and advancements in precision medicine.
• The market is segmented by indication, distribution channel, and region, with North America being the leading market.
• Ceritinib is projected to grow significantly, contributing to the overall growth of the global cancer ALK inhibitor market.
• The drug is cost-effective compared to other ALK inhibitors, making it a preferred option for many patients.
• The competitive landscape is dominated by major pharmaceutical companies, with Novartis being the primary manufacturer.

FAQs

1. What is ceritinib used for?

Ceritinib is used for the treatment of non-small cell lung cancer (NSCLC) that is ALK-positive, particularly for patients who have not responded to or cannot take crizotinib.

2. What are the key drivers of the ceritinib market?

The key drivers include the increasing prevalence of ALK-positive NSCLC, advancements in precision medicine, regulatory approvals, and favorable reimbursement policies.

3. Which region dominates the ceritinib market?

North America dominates the ceritinib market due to the high incidence of ALK-positive NSCLC and a robust healthcare system.

4. Is ceritinib cost-effective compared to other ALK inhibitors?

Yes, ceritinib has been shown to be cost-effective compared to other ALK inhibitors like crizotinib and alectinib, yielding additional QALYs at a favorable incremental cost.

5. What are the common side effects of ceritinib?

Common side effects of ceritinib include fatigue, increased liver enzymes, and gastrointestinal upset, which require continuous medical management.

Cited Sources:

1. We Market Research: Ceritinib Market By Indication, Distribution Channel & Region [2034][1]
2. PubMed: Cost Effectiveness of Ceritinib and Alectinib Versus Crizotinib in First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer[2]
3. GlobeNewswire: Global Cancer ALK Inhibitor Market is estimated to be US$ 10.6 billion by 2030[3]