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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZTALMY
*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
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
| 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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007062266 | ⤷ Sign Up | |
| Eurasian Patent Organization | 017290 | КОМПОЗИЦИИ НА ОСНОВЕ ГАНАКСОЛОНА (GANAXOLONE-BASED FORMULATIONS) | ⤷ Sign Up |
| China | 106667918 | 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) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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