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ZYKADIA Drug Profile
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» See Plans and PricingWhen 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: | 75 |
| Clinical Trials: | 9 |
| Patent Applications: | 85 |
| Drug Prices: | Drug price information for ZYKADIA |
| DailyMed Link: | ZYKADIA at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | Phase 3 |
| CIC-EC 1401/EUCLID | Phase 3 |
| Plateforme labellisée Inca – Hôpital Européen Georges Pompidou, Paris | Phase 3 |
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 |
| 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-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 |
| 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)ph |
| AB0096053 |
| AC-27469 |
| AK174337 |
| AKOS025396438 |
| AOB31713 |
| BCP07611 |
| BDBM50436850 |
| C28H36ClN5O3S |
| ceritinib |
| Ceritinib (JAN/USAN/INN) |
| Ceritinib (LDK378) |
| 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 |
| HMS3747A11 |
| HY-15656 |
| J-690011 |
| K418KG2GET |
| LDK 378 |
| LDK-378 |
| LDK-378|||Zykadia |
| LDK378 |
| LDK378 Certinib |
| LDK378(Ceritinib) |
| 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-LDK-378-NX |
| NVP-LDK378-NX |
| Q21011233 |
| 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 | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | Start Trial | Start Trial | 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 |
International Patents for ZYKADIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA02008370 | Start Trial |
| Eurasian Patent Organization | 201000366 | Start Trial |
| Israel | 214607 | Start Trial |
| Japan | 5208123 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYKADIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2091918 | C 2015 037 | Romania | Start Trial | PRODUCT NAME: CERITINIBSAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA5-CLOR-N2-{(5-METIL-4-(PIPERIDIN-4-IL)-2-[(PROPAN-2-IL)OXI]FENIL-N4-[2-(PROPAN-2-SULFONIL)FENIL}PIRIMIDIN-2,4-DIAMINA; NATIONAL AUTHORISATION NUMBER: EU/1/15/999; DATE OF NATIONAL AUTHORISATION: 20150506; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/999; DATE OF FIRST AUTHORISATION IN EEA: 20150506 |
| 1272477 | 132016000023559 | Italy | Start Trial | PRODUCT NAME: CERINITIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZIKADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/999, 20150508 |
| 1272477 | 529 | Finland | Start Trial | |
| 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 |
