ZYKADIA Drug Patent 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 seven patents protecting this drug.
This drug has two hundred and eighty-six 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.
DrugPatentWatch® 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: | 286 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 11 |
Patent Applications: | 761 |
Drug Prices: | Drug price information for ZYKADIA |
What excipients (inactive ingredients) are in ZYKADIA? | ZYKADIA excipients list |
DailyMed Link: | ZYKADIA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
---|---|
Plateforme labellisée Inca – Institut Bergonié, Bordeaux | Phase 3 |
Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris | Phase 3 |
Commissariat A L'energie Atomique | Phase 3 |
Pharmacology for ZYKADIA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inhibitors Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZYKADIA
US Patents and Regulatory Information for ZYKADIA
ZYKADIA is protected by seven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYKADIA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ZYKADIA
2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of using ALK inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting ZYKADIA
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ZYKADIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ZYKADIA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Zykadia | ceritinib | EMEA/H/C/003819 Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib. |
Authorised | no | no | no | 2015-05-06 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ZYKADIA
When does loss-of-exclusivity occur for ZYKADIA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4309
Estimated Expiration: ⤷ Try a Trial
Patent: 2395
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 11343775
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2013015000
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 21102
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 13001723
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3282359
Estimated Expiration: ⤷ Try a Trial
Patent: 4262324
Estimated Expiration: ⤷ Try a Trial
Patent: 6008462
Estimated Expiration: ⤷ Try a Trial
Patent: 6831716
Estimated Expiration: ⤷ Try a Trial
Patent: 7056751
Estimated Expiration: ⤷ Try a Trial
Patent: 2125884
Estimated Expiration: ⤷ Try a Trial
Patent: 4989139
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 01792
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0171477
Estimated Expiration: ⤷ Try a Trial
Patent: 0181737
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 19474
Estimated Expiration: ⤷ Try a Trial
Patent: 21017
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 51918
Estimated Expiration: ⤷ Try a Trial
Patent: 21171
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 13012770
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 51918
Estimated Expiration: ⤷ Try a Trial
Patent: 21171
Estimated Expiration: ⤷ Try a Trial
Patent: 53708
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1300153
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 41845
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6474
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 16752
Estimated Expiration: ⤷ Try a Trial
Patent: 13545812
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 51918
Estimated Expiration: ⤷ Try a Trial
Patent: 21171
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4810
Estimated Expiration: ⤷ Try a Trial
Patent: 7742
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 8210
Estimated Expiration: ⤷ Try a Trial
Patent: 13006952
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 771
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0713
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 140698
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 51918
Estimated Expiration: ⤷ Try a Trial
Patent: 21171
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 51918
Estimated Expiration: ⤷ Try a Trial
Patent: 21171
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 99785
Estimated Expiration: ⤷ Try a Trial
Patent: 46159
Estimated Expiration: ⤷ Try a Trial
Patent: 13132947
Estimated Expiration: ⤷ Try a Trial
Patent: 16136823
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 771
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 0856
Estimated Expiration: ⤷ Try a Trial
Patent: 201510082X
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 51918
Estimated Expiration: ⤷ Try a Trial
Patent: 21171
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1303599
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2325775
Estimated Expiration: ⤷ Try a Trial
Patent: 130130022
Estimated Expiration: ⤷ Try a Trial
Patent: 180032680
Patent: 5-클로로-N2--페닐]-피리미딘-2,4-디아민의 결정질 형태 (5--2-2--5--4--4---4[2--2--]--24- CRYSTALLINE FORMS OF 5-CHLORO-N2-2-ISOPROPOXY-5-METHYL-4-PIPERIDIN-4-YL-PHENYL-N4[2-PROPANE-2-SULFONYL-PHENYL]-PYRIMIDINE-24-DIAMINE)
Estimated Expiration: ⤷ Try a Trial
Patent: 190022903
Patent: 5-클로로-N2--페닐]-피리미딘-2,4-디아민의 결정질 형태 (5--2-2--5--4--4---4[2--2--]--24- CRYSTALLINE FORMS OF 5-CHLORO-N2-2-ISOPROPOXY-5-METHYL-4-PIPERIDIN-4-YL-PHENYL-N4[2-PROPANE-2-SULFONYL-PHENYL]-PYRIMIDINE-24-DIAMINE)
Estimated Expiration: ⤷ Try a Trial
Patent: 200039021
Patent: 5-클로로-N2--페닐]-피리미딘-2,4-디아민의 결정질 형태 (5--2-2--5--4--4---4[2--2--]--24- CRYSTALLINE FORMS OF 5-CHLORO-N2-2-ISOPROPOXY-5-METHYL-4-PIPERIDIN-4-YL-PHENYL-N4[2-PROPANE-2-SULFONYL-PHENYL]-PYRIMIDINE-24-DIAMINE)
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 43016
Estimated Expiration: ⤷ Try a Trial
Patent: 96526
Estimated Expiration: ⤷ Try a Trial
Patent: 05973
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 76343
Estimated Expiration: ⤷ Try a Trial
Patent: 76344
Estimated Expiration: ⤷ Try a Trial
Patent: 1307299
Estimated Expiration: ⤷ Try a Trial
Patent: 1629021
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 13000216
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ZYKADIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Guatemala | 201300153 | FORMAS CRISTALINAS DE 5-CLORO-N2-(2-ISOPROPOXI-5-METIL-4-PIPERIDIN-4-IL-FENIL)- N4-[2-(PROPAN-2-SULFONIL)-FENIL PIRIMIDIM-2,4-DIAMINA | ⤷ Try a Trial |
Chile | 2011001863 | Compuestos derivados de fenilaminopirimidinas, inhibidores de quinasa del linfoma anaplastico; composicion farmaceutica; combinacion farmacologica; y su uso en el tratamiento de trastornos proliferativos tales como linfoma, osteosarcoma, melanoma o tumor de mama, renal y de prostata, entre otros (divisional solicitud 3552-07). | ⤷ Try a Trial |
Croatia | P20040684 | SPOJEVI 2,4-PIRIMIDINDIAMINA I NJIHOVA UPOTREBA (2,4-PYRIMIDINEDIAMINE COMPOUNDS AND THEIR USES) | ⤷ Try a Trial |
Croatia | P20141260 | ⤷ Try a Trial | |
Brazil | PI0413616 | 2,4-pirimidinadiaminas úteis no tratamento de doenças neoplásicas, distúrbios inflamatórios e distúrbios do sistema imunológico | ⤷ Try a Trial |
Tunisia | SN06052 | 2,4-PYRIMIDINEDIAMINES USEFUL IN THE TREATMENT OF NEOPLASTIC DISEASES, INFLAMMATORY AND IMMUNE SYSTEM DISORDERS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZYKADIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1272477 | 529 | Finland | ⤷ Try a Trial | |
2091918 | 132016000025233 | Italy | ⤷ Try a Trial | PRODUCT NAME: CERITINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYKADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/999/001, 20150508 |
2091918 | 217 5020-2015 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: CERITINIB; REGISTRATION NO/DATE: EU/1/15/999 20150508 |
2091918 | 54/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508 |
1272477 | CR 2015 00050 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 20150508 |
1272477 | 1590048-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/999 20150508 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |