You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 15, 2024

Details for New Drug Application (NDA): 211225


✉ Email this page to a colleague

« Back to Dashboard


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.
Summary for 211225
Tradename:ZYKADIA
Applicant:Novartis
Ingredient:ceritinib
Patents:7
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.

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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Mar 18, 2019TE: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:⤷  Sign UpPatent Expiration:Apr 25, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 29, 2028Product Flag?YSubstance Flag?YDelist 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 ⤷  Sign Up ⤷  Sign Up
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Sign Up ⤷  Sign Up
Novartis ZYKADIA ceritinib TABLET;ORAL 211225-001 Mar 18, 2019 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.