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ZYKADIA Drug Profile

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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 twelve patents protecting this drug.

This drug has four hundred and one 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.

US ANDA Litigation and 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:	401
US Patents:	12
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	72
Clinical Trials:	9
Patent Applications:	85
Drug Prices:	Drug price information for ZYKADIA
DailyMed Link:	ZYKADIA at DailyMed

See drug prices for ZYKADIA

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
Institut Bergonié	Phase 3
Institut National de la Santé Et de la Recherche Médicale, France	Phase 3
CIC-EC 1401/EUCLID	Phase 3

See all ZYKADIA clinical trials

Pharmacology for ZYKADIA

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

Synonyms for ZYKADIA

1032900-25-6

1431456-10-8

2,4-Pyrimidinediamine, 5-chloro-N4-(2-((1-methylethyl)sulfonyl)phenyl)-N2-(5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl)-

2510AH

4CA-0729

4MK

5-chloro-2-N-(5-methyl-4-piperidin-4-yl-2-propan-2-yloxyphenyl)-4-N-(2-propan-2-ylsulfonylphenyl)pyrimidine-2,4-diamine

5-chloro-N(2)-{5-methyl-4-(piperidin-4-yl)-2-[(propan-2-yl)oxy]phenyl}-N(4)-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine

5-Chloro-N~2~-[5-Methyl-4-(Piperidin-4-Yl)-2-(Propan-2-Yloxy)phenyl]-N~4~-[2-(Propan-2-Ylsulfonyl)phenyl]pyrimidine-2,4-Diamine

5-Chloro-N~2~-{5-methyl-4-(piperidin-4-yl)-2-[(propan-2-yl)oxy]phenyl}-N~4~-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine

5-chloro-N2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-N4-(2-(isopropylsulfonyl)phenyl)pyrimidine-2,4-diamine

5-Chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2,4-diamine

5-Chloro-N2-(5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl)-N4-(2-(propane-2-sulfonyl)phenyl)pyrimidine-2,4-diamine

5-Chloro-N2-[2-isopropoxy-5-Methyl-4-(4-piperidyl)phenyl]-N4-(2-isopropylsulfonylphenyl)pyriMidine-2,4-diaMine

5-chloro-N2-[5-methyl-4-(piperidin-4-yl)-2-(propan-2-yloxy)phenyl]-N4-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine

5-Chloro-N4-[2-[(1-methylethyl)sulfonyl]phenyl]-N2-[5-methyl-2-(1-methylethoxy)-4-(4-piperidinyl)phenyl]-2,4-pyrimidinediamine

AB0096053

AC-27469

AK174337

AKOS025396438

AOB31713

BC600329

BCP07611

BDBM50436850

C28H36ClN5O3S

ceritinib

Ceritinib (JAN/USAN/INN)

Ceritinib [USAN:INN]

Ceritinib(LDK378)

ceritinibum

CHEBI:78432

CHEMBL2403108

compound 15b [PMID 23742252]

CS-1406

D10551

DB09063

DTXSID10725373

Eritinib (LDK378)

EX-A187

FT-0697208

GS-6356

GTPL7397

HMS3652H22

HY-15656

J-690011

K418KG2GET

KB-13070

LDK 378

LDK-378

LDK-378|||Zykadia

LDK378

LDK378 Certinib

LDK378(Ceritinib)

MolPort-035-395-774

N-{2-[(5-chloro-2-{[2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl]amino}pyrimidin-4-yl)amino]phenyl}propane-2-sulfonamide

N-{2-Methyl-5-[(methylamino)methyl]phenyl}-4-[(4-phenyl-2-quinazolinyl)amino]benzamide

NCGC00351603-10

NCGC00351603-15

NVP-LDK378-NX

QC-5183

S7083

SB16490

SC-93949

SCHEMBL1014329

SW219725-1

SYN1199

UNII-K418KG2GET

VERWOWGGCGHDQE-UHFFFAOYSA-N

W-6123

ZINC96272772

Zykadia (TN)

US Patents and Regulatory Information for 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	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
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes			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			Y	Y

International Patents for ZYKADIA

Country	Patent Number	Estimated Expiration
South Korea	20100050557
Brazil	PI0313059
Japan	5441841
European Patent Office	3012249
New Zealand	534361
Taiwan	I413641
Serbia	57771

Supplementary Protection Certificates for ZYKADIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1272477	2015/049	Ireland		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918	CR 2015 00047	Denmark		PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150508
2091918	15C0058	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	217 5020-2015	Slovakia		PRODUCT NAME: CERITINIB; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918	92785	Luxembourg		PRODUCT NAME: CERITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20150508
1272477	15C0064	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
1272477	1590048-3	Sweden		PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508