Details for New Drug Application (NDA): 211225
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NDA 211225 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 211225
Generic Entry Date for 211225*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 211225
Suppliers and Packaging for NDA: 211225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYKADIA | ceritinib | TABLET;ORAL | 211225 | NDA | Novartis Pharmaceuticals Corporation | 0078-0694 | 0078-0694-48 | 21 TABLET, FILM COATED in 1 BOTTLE (0078-0694-48) |
| ZYKADIA | ceritinib | TABLET;ORAL | 211225 | NDA | Novartis Pharmaceuticals Corporation | 0078-0694 | 0078-0694-84 | 84 TABLET, FILM COATED in 1 BOTTLE (0078-0694-84) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Mar 18, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 26, 2024 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 25, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 29, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 211225
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Subscribe | ⤷ Subscribe |
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Subscribe | ⤷ Subscribe |
| Novartis | ZYKADIA | ceritinib | TABLET;ORAL | 211225-001 | Mar 18, 2019 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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