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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 twelve patents protecting this drug.
This drug has four hundred and eight 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.
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: | 408 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 11 |
| Patent Applications: | 1,068 |
| Drug Prices: | Drug price information for ZYKADIA |
| What excipients (inactive ingredients) are in ZYKADIA? | ZYKADIA excipients list |
| DailyMed Link: | ZYKADIA at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| CIC-EC 1401/EUCLID | Phase 3 |
| Institut National de la Santé Et de la Recherche Médicale, France | Phase 3 |
| Plateforme labellisée Inca - Institut Bergonié, Bordeaux | 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 twelve US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZYKADIA is ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it Free.
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
Pyrimidine compounds
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Methods of using ALK inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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 it Free
Patent Expiration: ⤷ Try it Free
2,4-pyrimidinediamine compounds and their uses
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
FDA Regulatory Exclusivity protecting ZYKADIA
TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB.
Exclusivity Expiration: ⤷ Try it Free
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 it Free
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 it Free
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 it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| >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 it Free | ⤷ Try it Free |
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZYKADIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2012212142 | ⤷ Try it Free |
| Mexico | PA06001759 | ⤷ Try it Free |
| Russian Federation | 2493150 | ⤷ Try it Free |
| Spain | 2643016 | ⤷ Try it Free |
| South Korea | 20130130022 | ⤷ Try it Free |
| Australia | 2008252053 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ZYKADIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1272477 | 122015000073 | Germany | ⤷ Try it Free | PRODUCT NAME: CERITINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE; REGISTRATION NO/DATE: EU/1/15/999 20150506 |
| 1272477 | 15C0064 | France | ⤷ Try it Free | PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/15/999 20150508 |
| 2091918 | 54/2015 | Austria | ⤷ Try it Free | PRODUCT NAME: CERITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/999 (MITTEILUNG) 20180508 |
| 2091918 | 15C0058 | France | ⤷ Try it Free | PRODUCT NAME: CERITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/999 20150508 |
| 2091918 | CA 2015 00047 | Denmark | ⤷ Try it Free | PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150506 |
| 2091918 | 2015/047 | Ireland | ⤷ Try it Free | PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION: IRELAND EU/1/15/999 (C(2015) 3218), 20150506 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
