Ganaxolone - Generic Drug Details

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What are the generic 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
National Institute on Drug Abuse (NIDA)	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				⤷ 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
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 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
Eurasian Patent Organization	017290	КОМПОЗИЦИИ НА ОСНОВЕ ГАНАКСОЛОНА (GANAXOLONE-BASED FORMULATIONS)	⤷ Sign Up
Israel	264510	שיטות ותכשירים לטיפול בהפרעות אפילפטיות (Methods and compositions for treatment of epileptic disorders)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018031748		⤷ Sign Up
Japan	2009524582		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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