Details for New Drug Application (NDA): 215904
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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
Mechanism of Action | GABA A Receptor Positive Modulators |
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: | RX | Dosage: | SUSPENSION;ORAL | Strength | 50MG/ML | ||||
Approval Date: | Jun 1, 2022 | TE: | 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: | ⤷ Subscribe | Patent Expiration: | Aug 10, 2037 | Product 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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