Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 12, 2019

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Ceritinib - Generic Drug Details

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What are the generic drug sources for ceritinib and what is the scope of freedom to operate?

Ceritinib is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ceritinib has three hundred and ninety-three patent family members in fifty-five countries.

There is one drug master file entry for ceritinib. One supplier is listed for this compound.

Summary for ceritinib
International Patents:393
US Patents:12
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 71
Clinical Trials: 29
Patent Applications: 149
DailyMed Link:ceritinib at DailyMed
Recent Clinical Trials for ceritinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Intergroupe Francophone de Cancerologie ThoraciquePhase 2
Roche Pharma AGPhase 2
Instituto Nacional de Cancerologia de MexicoPhase 2

See all ceritinib clinical trials

Synonyms for ceritinib
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 (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
Zykadia (TN)

US Patents and Regulatory Information for ceritinib

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 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp ZYKADIA ceritinib CAPSULE;ORAL 205755-001 Apr 29, 2014 DISCN Yes No   Start Trial   Start Trial   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 ceritinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091918 15C0058 France   Start Trial PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508
1272477 1590048-3 Sweden   Start Trial PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508
2091918 92785 Luxembourg   Start Trial PRODUCT NAME: CERITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20150508
2091918 PA2015034,C2091918 Lithuania   Start Trial PRODUCT NAME: CERITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/999 20150506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Moodys
McKinsey
AstraZeneca
McKesson

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