Ganaxolone - Generic Drug Details

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What are the generic drug sources for ganaxolone and what is the scope of freedom to operate?

Ganaxolone is the generic ingredient in one branded drug marketed by Marinus and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ganaxolone has forty-three patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for ganaxolone

International Patents:	43
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	24
Patent Applications:	937
What excipients (inactive ingredients) are in ganaxolone?	ganaxolone excipients list
DailyMed Link:	ganaxolone at DailyMed

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

Generic Entry Date for ganaxolone^: ⤷ 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 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.

Recent Clinical Trials for ganaxolone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Massachusetts General Hospital	N/A
Marinus Pharmaceuticals	Phase 3
Jed E. Rose	Phase 2

See all ganaxolone clinical trials

Pharmacology for ganaxolone

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 ganaxolone

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for ganaxolone

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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	Y			⤷ Sign Up
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				⤷ Sign Up
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				⤷ 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 ganaxolone

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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 ganaxolone

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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
South Korea	20120107533	GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF	⤷ Sign Up
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)	⤷ Sign Up
Japan	2023126947	てんかん性障害の処置のための方法および組成物 (METHODS AND COMPOSITIONS FOR TREATMENT OF EPILEPTIC DISORDERS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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