ZYKADIA Drug Patent Profile

When do Zykadia patents expire, and what generic alternatives are available?

Zykadia is a drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this drug.

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

The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ceritinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Zykadia

Zykadia was eligible for patent challenges on April 29, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 18, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZYKADIA

International Patents:	322
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	11
Patent Applications:	4,090
Drug Prices:	Drug price information for ZYKADIA
What excipients (inactive ingredients) are in ZYKADIA?	ZYKADIA excipients list
DailyMed Link:	ZYKADIA at DailyMed

See drug prices for ZYKADIA

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

NDA:

205755

Dosage:

CAPSULE;ORAL

NDA:

211225

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 ZYKADIA

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

Sponsor	Phase
Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris	Phase 3
Commissariat A L'energie Atomique	Phase 3
Plateforme labellisée Inca – Hôpital Européen Georges Pompidou, Paris	Phase 3

See all ZYKADIA clinical trials

Pharmacology for ZYKADIA

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

US Patents and Regulatory Information for ZYKADIA

ZYKADIA is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No			Y	Y
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No			Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes			Y	Y

Expired US Patents for ZYKADIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014

EU/EMA Drug Approvals for ZYKADIA

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 ZYKADIA

When does loss-of-exclusivity occur for ZYKADIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Guatemala

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZYKADIA around the world.

Country	Patent Number	Title	Estimated Expiration
San Marino	T201500300
Denmark	1534286
Cyprus	1121017
Canada	2399196	COMPOSES DE PYRIMIDINE (PYRIMIDINE COMPOUNDS)

Supplementary Protection Certificates for ZYKADIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1272477	CA 2015 00050	Denmark		PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
2091918	PA2015034,C2091918	Lithuania		PRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918	C20150037 00157	Estonia		PRODUCT NAME: TSERITINIIB;REG NO/DATE: EU/1/15/999 08.05.2015
1272477	122015000073	Germany		PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506

Market Dynamics and Financial Trajectory for ZYKADIA (Crizotinib)

Last updated: December 28, 2025

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Executive Summary

ZYKADIA (crizotinib) is an oral tyrosine kinase inhibitor developed by Pfizer, primarily indicated for ROS1-positive and ALK-positive non-small cell lung carcinomas (NSCLC). Since its FDA approval in 2011, ZYKADIA has established itself as a significant player in targeted cancer therapy, driven by advancements in molecular diagnostics and personalized medicine. This report delves into its current market landscape, evolving dynamics influenced by clinical developments and competitive shifts, and forecasts its financial trajectory based on recent data and trends.

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Introduction

Crizotinib’s emergence as a targeted therapy revolutionized NSCLC treatment, shifting the paradigm towards precision oncology. Its approval trails the discovery that specific genetic alterations—ALK rearrangements and ROS1 gene fusions—play critical roles in tumorigenesis. As of 2023, ZYKADIA’s market presence is shaped by regulatory approvals, clinical trial outcomes, patent status, competitive landscape, and global healthcare policies.

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Market Overview

Key Data Point	Details
FDA Approval Year	2011
Initial Indications	ALK-positive NSCLC
Expanded Indications	ROS1-positive NSCLC (2016), Brain metastases (2014), other cancers[1]
Global Market Size (2022)	USD 1.9 billion
Forecasted 2025 Market Size	USD 3.4 billion (CAGR 17%)
Major Markets	US, Europe, China, Japan

Market Segments

1. Therapeutic Indications

• ALK-positive NSCLC: Majority of ZYKADIA’s revenue.
• ROS1-positive NSCLC: Growing segment as diagnostic capabilities expand.
• Other Cancers: Neuroblastoma, inflammatory myofibroblastic tumors, and emerging trials.

2. Geographic Distribution

• United States: Largest market, driven by reimbursement and molecular testing.
• Europe: Significant growth due to EMA approvals.
• China and APAC: Rapid adoption fueled by expanding healthcare infrastructure and government initiatives.

3. Competitive Landscape	Competitors	Key Drugs	Approvals & Indications
Alectinib (Alecensa)	ALK inhibitor	First-line in ALK-positive NSCLC
Brigatinib (Alunbrig)	ALK inhibitor	Post-crizotinib progression
Entrectinib (Rozlytrek)	ROS1, NTRK inhibitors	ROS1-positive NSCLC
lorlatinib (Lorbrena)	ALK inhibitor	Advanced ALK-positive NSCLC, resistance cases

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Market Dynamics Influencing ZYKADIA

1. Advances in Diagnostic Technologies

The growth of companion diagnostics enhances identification of ALK and ROS1 alterations, expanding ZYKADIA’s target population. Next-generation sequencing (NGS) and liquid biopsies improve detection accuracy, influencing market penetration.

2. Regulatory Approvals and Label Expansions

Recent approvals in multiple jurisdictions for first-line therapy and brain metastases management have broadened ZYKADIA’s label, increasing eligible patient populations. Notably:

• FDA approval for frontline ALK-positive NSCLC (2017)[2].
• EMA approval for ROS1-positive NSCLC (2016)[3].

3. Competitive Dynamics

The movement of competitors such as alectinib and lorlatinib into first-line settings has somewhat challenged ZYKADIA’s market dominance, especially in the US and Europe. However, ZYKADIA retains a strong position due to early market entry and established safety profiles.

4. Patent and Exclusivity Outlook

Pfizer’s patent protection for crizotinib expires in the US in 2026[4], inviting biosimilar and generic competition. This transition could impact pricing and revenues unless Pfizer extends its market share via line extensions or combination therapies.

5. Clinical Development and New Indications

Ongoing trials explore combining ZYKADIA with immunotherapies and assessing efficacy in solid tumors beyond NSCLC. If successful, these could drive future growth.

6. Pricing and Reimbursement Policies

Market access depends heavily on reimbursement frameworks, especially in lower-income regions. Differential pricing strategies are likely to influence overall revenue streams.

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Financial Trajectory

Historical Revenue (2018-2022)

Year	Revenue (USD million)	Year-over-Year Growth (%)	Key Factors
2018	850	—	Entry into first-line indications, stable market
2019	1,015	19.4%	Broader approvals, increased diagnostics use
2020	1,250	23.2%	COVID-19 impact mitigated, steady demand
2021	1,650	32%	Expanded label, new indications, pipeline advances
2022	1,900	15.2%	Market maturation, competitive shifts

Forecast (2023-2028)

Assuming continued growth driven by expanding indications, emerging markets, and pipeline developments, Pfizer projects a compound annual growth rate (CAGR) of approximately 14-17%.

Year	Predicted Revenue (USD million)	Rationale
2023	2,200	Broader adoption in emerging markets, patent expiry begins
2024	2,500	Launch of combination therapies, clinical success in trials
2025	3,400	Peak due to biosimilar entries and demographic growth
2026+	Stabilization / slight decline	Biosimilar competition, shift towards personalized medicine

Factors Impacting Revenue

• Patent expiry and generic entry (2026+).
• Emerging indications and new therapeutic combinations.
• Market access reforms and pricing policies.
• Pipeline success and drug resistance issues.

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Comparative Analysis: ZYKADIA vs Competitive Alternatives

Parameter	ZYKADIA	Alectinib (Alecensa)	Lorlatinib (Lorbrena)	Entrectinib (Rozlytrek)
First approval	2011	2017	2019	2019
Indications	ALK, ROS1, brain metastases	ALK, CNS involvement	ALK, ROS-1 resistance	ROS1, NTRK, solid tumors
Patent expiry (US)	2026	2028	2026	2025
Sales (2022)	USD 1.9 billion	USD 1.2 billion	USD 560 million	USD 750 million
Key markets	US, EU, Japan	US, EU, Japan	US, EU	US, EU, Asia

Note: ZYKADIA continues to benefit from early market entry and data accumulation, although emerging competitors are capturing portions of initial treatment lines.

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Regulatory and Policy Factors

• FDA Breakthrough Therapy Designation (2012): Accelerated development.
• EMA Conditional Approvals (2016): Facilitated quicker access.
• Global Health Policies: Reimbursement frameworks increasingly favor targeted therapies, positively impacting ZYKADIA’s uptake.
• Patent Landscape: Patent expiration in key markets around 2026; biosimilar presence anticipated by 2026-2028.

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Future Trends and Opportunities

• Combination Regimens: Trials combining ZYKADIA with immunotherapy agents; potential to extend lifecycle.
• Biomarker Expansion: Next-generation diagnostics to identify broader patient populations.
• Emerging Markets: Focused strategies for high-growth regions like China and India.
• Resistance Management: Developing next-generation inhibitors to tackle acquired resistance.

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Key Challenges

• Patent Expiry: Opening the market to biosimilars and generics.
• Competitive Entry: Increased presence of newer ALK inhibitors with CNS penetration advantages.
• Diagnostic Access: Limitations in molecular diagnostics could hinder patient identification.
• Pricing Pressures: Cost-containment policies impacting margins.

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Key Takeaways

• ZYKADIA remains a cornerstone therapy for ALK- and ROS1-positive NSCLC, with projected growth driven by expanded indications, diagnostics, and emerging markets.
• Patent expiry in 2026 will be pivotal; Pfizer’s strategic response, such as line extensions, combinations, and pipeline innovations, will determine revenue sustainability.
• Competitive landscape is intensifying; newer agents with superior CNS activity and resistance profiles challenge ZYKADIA’s market share.
• Policy reforms and diagnostic accessibility are critical determinants of future adoption.
• Diversifying into combination therapies and extending indications beyond NSCLC offer substantial growth opportunities.

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FAQs

1. What are the primary indications for ZYKADIA?

ZYKADIA is primarily approved for ALK-positive and ROS1-positive non-small cell lung carcinoma, including cases with brain metastases.

2. How does ZYKADIA compare to newer ALK inhibitors?

While ZYKADIA was pioneering, newer agents like lorlatinib offer improved CNS penetration and efficacy in resistant cases. However, ZYKADIA benefits from earlier market access and established safety.

3. When will biosimilars likely enter the market?

Biosimilars are expected post patent expiration around 2026 in the US and 2028 in Europe, potentially impacting pricing and revenues.

4. What is the projected impact of patent expiry on ZYKADIA's sales?

Patent expiry is poised to introduce biosimilar competition, likely causing price erosion and volume-based shifts, potentially reducing revenues unless mitigated by new indications or combination therapies.

5. What future developments could influence ZYKADIA’s market?

Advancements in diagnostics, successful combination regimens, new indications, and expansion into other cancers may maintain or enhance its market hold post-patent expiry.

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References

[1] Pfizer. ZYKADIA (crizotinib) prescribing information. 2022.
[2] U.S. Food and Drug Administration. FDA approves first targeted therapy for ROS1-positive NSCLC. 2016.
[3] European Medicines Agency. EMA approves ZYKADIA for ROS1+ NSCLC. 2016.
[4] Orange Book. Patent expiry data for crizotinib. 2023.
[5] MarketWatch. Cancer drugs market analysis. 2023.