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.
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: | ⤷ Sign Up | 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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