ZYKADIA Drug Patent Profile

When do Zykadia patents expire, and when can generic versions of Zykadia launch?

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

This drug has two hundred and eighty-six patent family members in fifty-four 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:	286
US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	11
Patent Applications:	782
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

Constraining patent/regulatory exclusivity:

9,309,229

NDA:

205755

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

9,309,229

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 - Institut Bergonié, Bordeaux	Phase 3
EUCLID Clinical Trial Platform	Phase 3
Plateforme labellisée Inca – Institut Bergonié, Bordeaux	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 seven US patents.

This potential generic entry date is based on patent 9,309,229.

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	8,377,921
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	7,964,592		Y	Y
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	8,399,450		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	9,018,204
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	8,835,430
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014	9,018,204

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/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 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

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
Brazil	PI0720264	compostos inibidores de proteÍna quinase, composiÇÕes contendo os mesmos bem como seus usos
Denmark	2651918
Morocco	30923	COMPOSES ET COMPOSITIONS INHIBANT LA PROTEINE KINASE

Supplementary Protection Certificates for ZYKADIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091918	15C0058	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	300763	Netherlands		PRODUCT NAME: CERITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	C 2015 037	Romania		PRODUCT NAME: CERITINIBSAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA5-CLOR-N2-{(5-METIL-4-(PIPERIDIN-4-IL)-2-[(PROPAN-2-IL)OXI]FENIL-N4-[2-(PROPAN-2-SULFONIL)FENIL}PIRIMIDIN-2,4-DIAMINA; NATIONAL AUTHORISATION NUMBER: EU/1/15/999; DATE OF NATIONAL AUTHORISATION: 20150506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/999; DATE OF FIRST AUTHORISATION IN EEA: 20150506

Market Dynamics and Financial Trajectory for ZYKADIA

Introduction to ZYKADIA

ZYKADIA, developed by Novartis, is a targeted therapy used to treat adults with a specific type of non-small-cell lung cancer (NSCLC) characterized by the presence of anaplastic lymphoma kinase (ALK) gene rearrangements. Here, we delve into the market dynamics and financial trajectory of ZYKADIA.

Approval and Regulatory Status

ZYKADIA was initially granted conditional approval by the European Medicines Agency (EMA) due to the need for additional evidence. However, after providing the necessary data, the approval was converted to full approval[3].

Clinical Efficacy

ZYKADIA has demonstrated significant clinical efficacy in treating ALK-positive NSCLC patients. Studies have shown that ZYKADIA improves progression-free survival compared to standard chemotherapy. For example, in a study involving 231 patients, ZYKADIA extended the time patients lived without their disease worsening to 5.4 months, compared to 1.6 months with standard chemotherapy[3].

Market Position and Competition

ZYKADIA operates in a competitive landscape dominated by other ALK inhibitors. Roche's Alecensa is a key competitor, which has shown superior efficacy and safety in some studies. Alecensa has already outperformed ZYKADIA in sales, with $74 million in sales in the first half of 2016 compared to ZYKADIA's $48 million during the same period[4].

Sales Projections and Financial Performance

Despite the competitive environment, ZYKADIA is expected to achieve notable sales. By 2020, analysts projected ZYKADIA sales to reach $320 million. However, this figure is lower than Alecensa's projected sales, indicating a challenging market environment[4].

In the broader NSCLC market, targeted therapies, including ALK inhibitors like ZYKADIA, are expected to contribute significantly. The sales of ALK-TKIs are projected to grow at a CAGR of 10.7% over the forecast period, with ZYKADIA contributing to this growth, albeit at a slower pace than some of its competitors[1].

Challenges and Opportunities

Patent Expirations and Generic Erosion

The NSCLC market is also impacted by patent expirations of older drugs, which can lead to increased generic competition. While ZYKADIA itself is not immediately threatened by patent expirations, the overall market dynamics can affect its growth. For instance, the patent expiration of other blockbuster drugs like Tarceva and Alimta will lead to a shift towards generics, which could indirectly impact the sales of newer targeted therapies[1].

First-Line Indication

ZYKADIA is currently approved for patients who have failed on other treatments like Pfizer's Xalkori. However, Novartis is seeking a first-line indication, which could significantly boost its market share. New data showing ZYKADIA's efficacy in previously untreated patients could support this regulatory push, although the competition from Alecensa remains a hurdle[4].

Side Effects and Safety Profile

ZYKADIA's safety profile is generally manageable, with common side effects including diarrhea, nausea, vomiting, and abnormal liver tests. Severe reactions are less common but include hyperglycemia and kidney problems. The EMA has concluded that the benefits of ZYKADIA outweigh its risks, supporting its continued use in the EU[3].

Financial Trajectory

Revenue Growth

ZYKADIA's revenue growth is expected to be moderate compared to other drugs in the NSCLC market. While it will contribute to the overall growth of targeted therapies, its sales are projected to be lower than those of its main competitor, Alecensa. By 2025, the total sales of ALK-TKIs are expected to grow, but ZYKADIA's share will be smaller compared to Alecensa and other targeted therapies[1].

Market Share

In the competitive ALK inhibitor market, ZYKADIA faces significant competition from Alecensa. Alecensa's superior efficacy and safety profile, as well as its earlier move into the first-line setting, give it an edge. This competition is expected to continue, with analysts predicting that Alecensa will maintain its lead over ZYKADIA in terms of sales and market share[4].

Key Takeaways

• Clinical Efficacy: ZYKADIA has shown significant clinical benefits in treating ALK-positive NSCLC patients.
• Market Competition: ZYKADIA faces strong competition from Roche's Alecensa, which has superior efficacy and safety.
• Sales Projections: Despite competition, ZYKADIA is expected to achieve moderate sales growth, though lower than Alecensa.
• Regulatory Status: ZYKADIA has full approval from the EMA and is seeking a first-line indication.
• Safety Profile: ZYKADIA's side effects are generally manageable, with the EMA concluding that its benefits outweigh its risks.

FAQs

Q: What is ZYKADIA used for?

ZYKADIA is used to treat adults with non-small-cell lung cancer (NSCLC) characterized by the presence of anaplastic lymphoma kinase (ALK) gene rearrangements.

Q: How does ZYKADIA compare to Alecensa in terms of efficacy?

Alecensa has shown superior efficacy and safety compared to ZYKADIA in some studies, particularly in the first-line setting.

Q: What are the common side effects of ZYKADIA?

Common side effects include diarrhea, nausea, vomiting, and abnormal liver tests. Severe reactions can include hyperglycemia and kidney problems.

Q: Is ZYKADIA approved for first-line use?

Currently, ZYKADIA is not approved for first-line use but is being considered for this indication based on new clinical data.

Q: How does the patent expiration of other drugs impact ZYKADIA?

The patent expiration of older drugs leads to increased generic competition, which can indirectly affect the sales of newer targeted therapies like ZYKADIA by changing market dynamics.

Sources

1. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - Drug Development
2. Merus Announces Financial Results for the Second Quarter and Provides Financial Outlook - Merus
3. Zykadia - European Medicines Agency (EMA)
4. Novartis' new Zykadia data put first-line nod in sight, but a Roche showdown looms - FiercePharma
5. BeiGene Reports First Quarter 2022 Financial Results - BeiGene