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 eleven patents protecting this drug.

This drug has three hundred and eighty-five patent family members in fifty-five 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:	385
US Patents:	11
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	11
Patent Applications:	1,267
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 Generic Entry Opportunity 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 – Institut Bergonié, Bordeaux	Phase 3
Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris	Phase 3
Commissariat A L'energie Atomique	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

Anatomical Therapeutic Chemical (ATC) Classes for ZYKADIA

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

US Patents and Regulatory Information for ZYKADIA

ZYKADIA is protected by eleven US patents and two FDA Regulatory Exclusivities.

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

Patents protecting ZYKADIA

FDA Regulatory Exclusivity protecting ZYKADIA

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	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes			Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes
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	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No
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	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	TABLET;ORAL	211225-001	Mar 18, 2019
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014
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/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
South Korea	101149295
Iceland	8349	2,4-pýrimídíndíamín gagnleg í meðhöndlun æxlissjúkdóma, bólgu- og ónæmiskerfissjúkdóma
Spain	2524009
European Patent Office	2091918	COMPOSÉS ET COMPOSITIONS INHIBANT LA PROTÉINE KINASE (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS)
Cyprus	1114238
Poland	2091918
Russian Federation	2493150	СОЕДИНЕНИЯ 2,4-ПИРИМИДИНДИАМИНОВ И ИХ ПРИМЕНЕНИЕ (2,4-PYRIMIDINE DIAMINE COMPOUNDS AND USE THEREOF)

Supplementary Protection Certificates for ZYKADIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091918	217 5020-2015	Slovakia		PRODUCT NAME: CERITINIB; REGISTRATION 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
2091918	PA2015034,C2091918	Lithuania		PRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477	122015000073	Germany		PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477	CR 2015 00050	Denmark		PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508
2091918	PA2015034	Lithuania		PRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
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