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ZYKADIA Drug Profile
» See Plans and Pricing
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 four hundred and four patent family members in fifty-five countries.
The generic ingredient in ZYKADIA is ceritinib. There is one drug master file entry 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: | 404 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 2 |
Bulk Api Vendors: | 83 |
Clinical Trials: | 9 |
Patent Applications: | 779 |
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 |
---|---|
Plateforme labellisée Inca – Institut Bergonié, Bordeaux | Phase 3 |
Institut Bergonié | Phase 3 |
Institut National de la Santé Et de la Recherche Médicale, France | Phase 3 |
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 | 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 | ||
Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | 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 | ||
Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | RX | Yes | Yes | 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 |
---|---|---|
Eurasian Patent Organization | 201391114 | Start Trial |
Norway | 20061214 | Start Trial |
Taiwan | 201033588 | Start Trial |
Morocco | 34771 | Start Trial |
Russian Federation | 2013132947 | Start Trial |
Canada | 2492325 | Start Trial |
Russian Federation | 2493150 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYKADIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1272477 | 122015000073 | Germany | Start Trial | PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506 |
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 | 54/2015 | Austria | Start Trial | PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508 |
2091918 | 15C0058 | France | Start Trial | PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508 |
2091918 | CA 2015 00047 | Denmark | Start Trial | PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150506 |
2091918 | 2015/047 | Ireland | Start Trial | PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506 |
2091918 | 300763 | Netherlands | Start Trial | PRODUCT NAME: CERITINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/999 20150508 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |