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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 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 four hundred and four 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: | 404 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 30 |
| Patent Applications: | 939 |
| DailyMed Link: | ceritinib at DailyMed |
Recent Clinical Trials for ceritinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 4 |
| Intergroupe Francophone de Cancerologie Thoracique | Phase 2 |
| Instituto Nacional de Cancerologia de Mexico | Phase 2 |
Pharmacology for ceritinib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tyrosine Kinase Inhibitors Cytochrome P450 3A Inhibitors Cytochrome P450 2C9 Inhibitors |
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 | 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 | Start Trial | ||||
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | DISCN | Yes | No | Start Trial | Start Trial | 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 ceritinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2009032703 | Start Trial |
| Austria | 524184 | Start Trial |
| China | 103641833 | Start Trial |
| Japan | 2007502260 | Start Trial |
| Norway | 331977 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ceritinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2091918 | 1590054-1 | Sweden | Start Trial | PRODUCT NAME: CERITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/15/999 20150508 |
| 1272477 | SPC/GB15/057 | United Kingdom | Start Trial | PRODUCT NAME: CERITINIB, AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/15/999 20150508 |
| 2091918 | 528 | Finland | Start Trial | |
| 2091918 | CR 2015 00047 | Denmark | Start Trial | PRODUCT NAME: CERITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/15/999 (C(2015)3218) 20150508 |
| 2091918 | 92785 | Luxembourg | Start Trial | PRODUCT NAME: CERITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20150508 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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