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Last Updated: November 19, 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 and is included in two NDAs. There are twelve patents protecting this drug.

This drug has three hundred and ninety-three 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.

Summary for ZYKADIA
Drug patent expirations by year for ZYKADIA
Drug Prices for ZYKADIA

See drug prices for ZYKADIA

Generic Entry Opportunity Date for ZYKADIA
Generic Entry Dates for ZYKADIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for ZYKADIA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Plateforme labellisée Inca – Institut Bergonié, BordeauxPhase 3
Institut BergoniéPhase 3
Institut National de la Santé Et de la Recherche Médicale, FrancePhase 3

See all ZYKADIA clinical trials

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   Start Trial   Start Trial   Start Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Novartis ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZYKADIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091918 528 Finland   Start Trial
1272477 15C0064 France   Start Trial PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508
2091918 PA2015034 Lithuania   Start Trial PRODUCT NAME: CERITINIBUM; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 2015/049 Ireland   Start Trial PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/999 20150506
1272477 122015000073 Germany   Start Trial PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506
2091918 122015000076 Germany   Start Trial PRODUCT NAME: CERITINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 20150506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Baxter
Dow
Express Scripts
Merck

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