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ZTALMY Drug Patent Profile

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

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

See drug prices for ZTALMY

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

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

Anatomical Therapeutic Chemical (ATC) Classes for ZTALMY

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for ZTALMY

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

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

FDA Regulatory Exclusivity protecting ZTALMY

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
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes			Y
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes			Y
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes			Y
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes
Marinus	ZTALMY	ganaxolone	SUSPENSION;ORAL	215904-001	Jun 1, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for ZTALMY

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

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)

Australia

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

New Zealand

South Korea

Spain

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.

Country	Patent Number	Title	Estimated Expiration
Mexico	2008006888	FORMULAS Y METODOS PARA LA MANUFACTURA Y USO DE LA GANAXOLONA. (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF.)
Canada	2631233	FORMES GALENIQUES DE GANAXOLONE ET PROCEDES DE PREPARATION ET D'UTILISATION DE CELLES-CI (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF)
Mexico	336930	FORMULACIONES DE GANAXOLONA Y METODOS PARA LA MANUFACTURA Y EL USO DE LAS MISMAS. (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF.)
Japan	2009524582
South Korea	101415329
Japan	2013064008	GANAXOLONE FORMULATION AND METHOD FOR PREPARING THE SAME AND USE THEREOF