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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 Pharms Corp and is included in one NDA. There are twelve patents protecting this drug.

This drug has three hundred and seventy 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.

Summary for ZYKADIA

International Patents:	370
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	53
Clinical Trials:	5
Patent Applications:	46
DailyMed Link:	ZYKADIA at DailyMed

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

AB0096053

AC-27469

AK174337

AKOS025396438

AOB31713

BC600329

BDBM50436850

C28H36ClN5O3S

ceritinib

Ceritinib (JAN/USAN/INN)

Ceritinib (LDK378)

Ceritinib [USAN:INN]

Ceritinib(LDK378)

ceritinibum

CHEBI:78432

CHEMBL2403108

compound 15b [PMID 23742252]

CS-1406

D04LVK

D0KJ9P

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

MFCD26142648

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

NVP-LDK378-NX

QC-5183

S7083

SC-93949

SCHEMBL1014329

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 Pharms Corp	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		RX	Yes	Yes
Novartis Pharms Corp	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		RX	Yes	Yes			Y	Y

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Non-Orange Book US Patents for ZYKADIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,040,550	2,4-pyrimidinediamine compounds and their uses
7,906,644	2,4-pyrimidinediamine compounds and their uses
7,329,671	2,4-pyrimidinediamine compounds and their uses
8,372,858	Compounds and compositions as protein kinase inhibitors

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International Patents for ZYKADIA

Country	Document Number	Estimated Expiration
Taiwan	I576344
European Patent Office	2091918
European Patent Office	1606265
Portugal	1471915

Supplementary Protection Certificates for ZYKADIA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0064	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
C0058	France		PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
824	Luxembourg		PRODUCT NAME: CERITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20150508
0763	Netherlands		PRODUCT NAME: CERITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/999 20150508