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Last Updated: December 28, 2024

Details for New Drug Application (NDA): 215904


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NDA 215904 describes ZTALMY, which is a drug marketed by Marinus and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZTALMY profile page.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this compound. Additional details are available on the ganaxolone profile page.
Summary for 215904
Tradename:ZTALMY
Applicant:Marinus
Ingredient:ganaxolone
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215904
Generic Entry Date for 215904*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER
Dosage:
SUSPENSION;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: 215904
Suppliers and Packaging for NDA: 215904
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZTALMY ganaxolone SUSPENSION;ORAL 215904 NDA Marinus Pharmaceuticals, Inc. 81583-100 81583-100-01 1 BOTTLE, PLASTIC in 1 CARTON (81583-100-01) / 110 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/ML
Approval Date:Jun 1, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 1, 2027
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 1, 2029
Regulatory Exclusivity Use:TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER
Patent:⤷  SubscribePatent Expiration:Aug 10, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER

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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.