Details for New Drug Application (NDA): 205755
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NDA 205755 describes ZYKADIA, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ZYKADIA profile page.
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.
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® Estimated Loss of Exclusivity (LOE) Date for 205755
Generic Entry Date for 205755*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Apr 29, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 26, 2024 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | 7,893,074 | Patent Expiration: | Apr 25, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 7,964,592 | Patent Expiration: | Apr 29, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 205755
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | 9,416,112 | ⤷ Subscribe |
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | 7,153,964 | ⤷ Subscribe |
| Novartis | ZYKADIA | ceritinib | CAPSULE;ORAL | 205755-001 | Apr 29, 2014 | 9,018,204 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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