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ZTALMY Drug Patent Profile

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Which patents cover Ztalmy, and what generic alternatives are available?

Ztalmy is a drug marketed by Marinus and is included in one NDA. There are eight patents protecting this drug.

This drug has forty-three patent family members in fifteen countries.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this compound. Additional details are available on the ganaxolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Ztalmy

Ztalmy will be eligible for patent challenges on June 1, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 1, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZTALMY

International Patents:	43
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Patent Applications:	558
Drug Prices:	Drug price information for ZTALMY
What excipients (inactive ingredients) are in ZTALMY?	ZTALMY excipients list
DailyMed Link:	ZTALMY at DailyMed

Drug patent expirations by year for ZTALMY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZTALMY

Generic Entry Date for ZTALMY^: ⤷ Sign Up* 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 NDA: 215904 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 ZTALMY

Drug Class	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators

US Patents and Regulatory Information for ZTALMY

ZTALMY is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZTALMY is ⤷ Sign Up.

This potential generic entry date is based on TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZTALMY

Methods and compositions for treatment of epileptic disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER

Solid ganaxolone formulations and methods for the making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Liquid ganaxolone formulations and methods for the making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid ganaxolone formulations and methods for the making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid ganaxolone formulations and methods for the making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER

Solid ganaxolone compositions and methods for the making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Liquid ganaxolone formulations and methods for the making and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting ZTALMY

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for ZTALMY

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Marinus Pharmaceuticals Emerald Limited	Ztalmy	ganaxolone	EMEA/H/C/005825 Ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 to 17 years of age. Ztalmy may be continued in patients 18 years of age and older.	Authorised	no	no	yes	2023-07-26
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ZTALMY

When does loss-of-exclusivity occur for ZTALMY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 71
Patent: Ganaxolone formulations and methods for the makingand use thereof
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 06318349
Patent: Ganaxolone formulations and methods for the making and use thereof
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 31233
Patent: FORMES GALENIQUES DE GANAXOLONE ET PROCEDES DE PREPARATION ET D'UTILISATION DE CELLES-CI (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up

China

Patent: 1583620
Patent: Ganaxolone formulations and methods for the making and use thereof
Estimated Expiration: ⤷ Sign Up

Patent: 6667918
Patent: 加奈索酮组合物及其制备和使用方法 (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 7290
Patent: КОМПОЗИЦИИ НА ОСНОВЕ ГАНАКСОЛОНА (GANAXOLONE-BASED FORMULATIONS)
Estimated Expiration: ⤷ Sign Up

Patent: 0801468
Patent: ПРЕПАРАТЫ ГАНАКСОЛОНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 59966
Patent: FORMES GALÉNIQUES DE GANAXOLONE ET PROCÉDÉS DE PREPARATION ET D'UTILISATION DE CELLES-CI (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 1759
Patent: תכשירי גנקסולון ושיטות להכנתם ושימוש בהם (Ganaxolone formulations and methods for the making and use thereof)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 34588
Estimated Expiration: ⤷ Sign Up

Patent: 48732
Estimated Expiration: ⤷ Sign Up

Patent: 09524582
Estimated Expiration: ⤷ Sign Up

Patent: 13064008
Patent: GANAXOLONE FORMULATION AND METHOD FOR PREPARING THE SAME AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 6930
Patent: FORMULACIONES DE GANAXOLONA Y METODOS PARA LA MANUFACTURA Y EL USO DE LAS MISMAS. (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF.)
Estimated Expiration: ⤷ Sign Up

Patent: 08006888
Patent: FORMULAS Y METODOS PARA LA MANUFACTURA Y USO DE LA GANAXOLONA. (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 8700
Patent: Solid stabilized particulate formulations comprising ganaxolone
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1405545
Estimated Expiration: ⤷ Sign Up

Patent: 1415329
Estimated Expiration: ⤷ Sign Up

Patent: 080072760
Patent: GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Patent: 120107533
Patent: GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Patent: 130123471
Patent: GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 12250
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZTALMY around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	4233861	COMPOSITIONS POUR LE TRAITEMENT DU TREMBLEMENT ESSENTIEL (COMPOSITIONS FOR TREATMENT OF ESSENTIAL TREMOR)	⤷ Sign Up
South Korea	20080072760	GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF	⤷ Sign Up
Spain	2812250		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration