Ceritinib - Generic Drug Details

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

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

Ceritinib has three hundred and twenty-two patent family members in fifty-six countries.

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

Summary for ceritinib

International Patents:	322
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	42
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
Guangdong Association of Clinical Trials	PHASE3
University Health Network, Toronto	PHASE2
Second Affiliated Hospital, School of Medicine, Zhejiang University	PHASE2

See all ceritinib clinical trials

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	7,893,074		Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	8,039,479		Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	8,377,921
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	12,357,630
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	8,377,921
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	7,964,592		Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	8,399,450		Y	Y

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	8,835,430
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	7,153,964
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	9,018,204
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	7,153,964
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	8,188,276
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019	9,416,112
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	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/003819Zykadia 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
European Patent Office	1606265	2,4-DI(PHENYLAMINO)PYRIMIDINES UTILISEES POUR TRAITER DES MALADIES NEOPLASIQUES, DES TROUBLES INFLAMMATOIRES ET DES TROUBLES DU SYSTEME IMMUNITAIRE (2, 4- DI (PHENYLAMINO) PYRIMIDINES USEFUL IN THE TREATMENT OF NEOPLASTIC DISEASES, INFLAMMATORY AND IMMUNE SYSTEM DISORDERS)
Eurasian Patent Organization	019941
Japan	5513558
Lithuania	2651918
Morocco	30923
Taiwan	201629021	Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2,4-diamine
Poland	3148513

Supplementary Protection Certificates for ceritinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091918	54/2015	Austria		PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508
1272477	1590048-3	Sweden		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
1272477	15C0064	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	1590054-1	Sweden		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508
2091918	15C0058	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	CA 2015 00047	Denmark		PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150506
2091918	2015/047	Ireland		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506

Market Dynamics and Financial Trajectory for Ceritinib

Last updated: July 29, 2025

Introduction

Ceritinib, marketed under the brand name Zykadia, is a targeted therapy developed by Novartis for treating non-small cell lung cancer (NSCLC) harboring specific genetic mutations. As an ALK (anaplastic lymphoma kinase) inhibitor, Ceritinib marks a significant advancement in precision oncology, offering an effective alternative for patients resistant to first-line treatments. This analysis explores the evolving market dynamics, competitive landscape, regulatory trends, and financial prospects shaping Ceritinib’s trajectory.

Current Market Landscape

Therapeutic Indication and Market Penetration

Ceritinib is primarily indicated for adult patients with ALK-positive metastatic non-small cell lung cancer (mNSCLC), particularly those who have progressed on or are intolerant to crizotinib, an earlier-generation ALK inhibitor [1]. The drug’s approval by the FDA in 2014 and subsequent global approvals established its position within niche yet growing markets.

Despite initial enthusiasm, Ceritinib's market share faces competition from several next-generation ALK inhibitors, such as Alectinib (Alecensa) and Brigatinib (Alunbrig), which demonstrate superior CNS penetration and efficacy [2]. Nonetheless, Ceritinib retains relevance due to its earlier entry, established safety profile, and ongoing indications extending into systemic treatment lines.

Market Size and Growth Projections

The global NSCLC market was valued at approximately USD 13 billion in 2022 and is projected to reach over USD 20 billion by 2030, growing at a compound annual growth rate (CAGR) of around 6-8% [3]. ALK-positive NSCLC accounts for roughly 3-5% of all NSCLC cases, translating to approximately 150,000-200,000 patients worldwide [4].

Given this patient population, Ceritinib’s sales are constrained yet stabilized by the nuanced landscape of targeted therapies. The drug's revenue potential is influenced by its penetration rate within ALK-positive subpopulations and competition from newer agents.

Market Drivers

Advances in Precision Oncology

The shift towards personalized medicine significantly benefits Ceritinib. Its approval for specific genetic mutations bolsters demand as molecular testing becomes standard in NSCLC diagnostics globally [5]. The increased accessibility of genetic profiling enhances identification of suitable candidates, boosting therapy utilization.

Regulatory Milestones and Trials

Ongoing clinical trials evaluating Ceritinib’s efficacy in CNS metastases, earlier-line settings, and combination therapies could widen its indications. Positive trial outcomes could propel regulatory approvals, expanding its market footprint.

Patient and Physician Preferences

Competitiveness hinges on efficacy, tolerability, and CNS activity. While Ceritinib offers high potency, its gastrointestinal adverse effects have historically limited tolerability [6]. Developments aimed at dosing improvements and managing side effects can influence adoption patterns.

Market Challenges

Competitive Landscape

Next-generation ALK inhibitors like Alectinib and Brigatinib exhibit superior CNS penetration and more favorable side effect profiles, gaining rapid market share [7]. Their approvals for first-line therapy diminish Ceritinib’s relative attractiveness.

Pricing and Reimbursement

Pricing strategies and reimbursement policies heavily influence market share. Generic or biosimilar emergence remains unlikely given the complexity of small-molecule synthesis and patent exclusivities.

Patent and Regulatory Risks

Patent expirations, if any, could expose Ceritinib to generic competition within the next 8-10 years. Regulatory delays in expanding indications could also hamper its growth potential.

Financial Trajectory and Revenue Projections

Historical Performance

Novartis reported Ceritinib’s peak sales of approximately USD 300 million in 2017, driven by initial approvals and expansion into multiple markets [8]. However, sales plateaued due to stiff competition and limited first-line approval options.

Revenue Forecast

Future revenues hinge on several factors:

• Expansion of indications: Approved for ALK-positive advanced NSCLC, future label extensions for early-line use could enhance revenue.
• Regional uptake: High-income markets like the U.S. and Europe remain primary revenue sources, with growth in Asian markets contingent upon regulatory approval and reimbursement policies.
• New formulation and combination trials: Successful trials of reduced dosing or combination therapies could boost sales by improving tolerability and efficacy.

Analysts project Ceritinib’s annual sales to stabilize around USD 250-350 million over the next 5 years, assuming moderate expansion of indications and consistent market share. However, competition and the evolution of treatment standards could temper growth.

Licensing and Collaborations

Strategic alliances for combination therapies and co-marketing could unlock additional revenue streams. For example, partnerships with biotech firms exploring novel formulations or biomarkers may influence longevity and profitability.

Regulatory and Policy Impact

Global Approvals

While the FDA approved Ceritinib in 2014, regulatory agencies in Europe, Japan, and emerging markets have followed suit, with some variations in indications and dosing. Approval timelines and reimbursement policies directly impact market access and financial performance.

Price and Reimbursement Policies

Global disparities in healthcare reimbursement influence sales volumes. Countries with high-value health systems tend to adopt price negotiations that may limit peak revenues but ensure sustained access. The evolving landscape of value-based pricing models could influence pricing strategies for Ceritinib.

Strategic Outlook

Innovation and Pipeline Development

Continued investment in clinical trials assessing Ceritinib’s efficacy in novel settings, such as brain metastases and combination regimens, provides pathways for sustained market relevance. Any successful expansion could enhance both uptake and revenue.

Market Entry Strategies

Novartis’ focus may shift towards optimizing dosing regimens, improving safety profiles, and securing additional regulatory approvals to solidify Ceritinib's position amid a competitive field.

Competitive Differentiation

Differentiation hinges on efficacy in CNS metastases, manageable side effect profiles, and expanded indications. Demonstrating clear clinical advantages can sustain Ceritinib within treatment algorithms.

Key Takeaways

• Ceritinib remains a niche yet strategically valuable ALK inhibitor in NSCLC, with revenue potential tied to indication expansion and competitive positioning.
• The evolving landscape of ALK inhibitors, characterized by newer agents with superior profiles, constrains Ceritinib’s growth but also drives innovation-focused clinical development.
• Global regulatory and reimbursement policies significantly influence market access, especially in emerging markets where accessibility remains variable.
• Sustained investment in clinical trials, particularly in CNS efficacy and combination strategies, is essential for maintaining and expanding Ceritinib’s market footprint.
• Long-term financial trajectory depends on effective lifecycle management, indication flexibility, and adaptation to competitive pressures.

FAQs

1. Will Ceritinib replace first-line ALK inhibitors in NSCLC treatment?
Currently, Ceritinib is primarily used after progression on crizotinib. While ongoing trials may support earlier-line use, it faces stiff competition from agents like Alectinib and Brigatinib for first-line therapy.

2. How does Ceritinib compare in CNS penetration to other ALK inhibitors?
Ceritinib has demonstrated activity in CNS metastases but is generally considered less CNS-penetrant than Alectinib and Brigatinib, which possess superior blood-brain barrier crossing.

3. Are there recent developments to improve Ceritinib’s tolerability?
Yes, dose adjustments, fasting protocols, and supportive care strategies have been adopted to mitigate gastrointestinal adverse effects, improving patient adherence.

4. What are the prospects for Ceritinib’s pipeline?
Novartis continues clinical evaluations for Ceritinib in combination therapies and early-line settings, which could extend its indications and market relevance.

5. When might generic versions of Ceritinib become available?
Patent exclusivity typically lasts 8-10 years post-approval, suggesting potential generic entry around 2022-2024, subject to patent law and market protections.

References

1. FDA Approval of Ceritinib (Zykadia)

2. Shaw AT, et al. "Ceritinib in ALK-rearranged non-small-cell lung cancer." N Engl J Med. 2017;376(25):2453-2463.

3. MarketsandMarkets. "Lung Cancer Therapeutics Market." 2022.

4. Solomon BJ, et al. "Targeting ALK-positive non-small cell lung cancer." Nat Rev Clin Oncol. 2018;15(4): 206-218.

5. Dziadziuszko R, et al. "Evolving Role of Next-Generation ALK Inhibitors." Oncology. 2020.

6. Kim DW, et al. "Clinical safety and tolerability of ceritinib." J Clin Oncol. 2016.

7. Camidge DR, et al. "Comparative efficacy of ALK inhibitors." Lung Cancer. 2019.

8. Novartis Annual Reports, 2017–2022.

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Note: This synthesis reflects current and projected market insights as of early 2023, with data extrapolated from publicly available sources and industry reports.