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Generated: February 21, 2019

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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
Drug patent expirations by year for ZYKADIA
Generic Entry Opportunity Date for ZYKADIA
Generic Entry Date for ZYKADIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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.

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for ZYKADIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
15/049 Ireland ➤ Sign Up PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
2015034 Lithuania ➤ Sign Up PRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
2015000076 Germany ➤ Sign Up PRODUCT NAME: CERITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 20150506
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Fish and Richardson
McKinsey
Teva
Baxter
Citi
Medtronic
UBS
Harvard Business School

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