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Ganaxolone Patent Expiration

Ganaxolone is Used for treating seizures associated with CDKL5 deficiency disorder in patients aged 2 years and older. It was first introduced by Marinus Pharmaceuticals Inc in its drug Ztalmy on Jun 1, 2022.


Ganaxolone Patents

Given below is the list of patents protecting Ganaxolone, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Ztalmy US10603308 Methods and compositions for treatment of epileptic disorders Aug 10, 2037 Marinus
Ztalmy US7858609 Solid ganaxolone formulations and methods for the making and use thereof Nov 28, 2026 Marinus
Ztalmy US8022054 Liquid ganaxolone formulations and methods for the making and use thereof Nov 28, 2026 Marinus
Ztalmy US8318714 Liquid ganaxolone formulations and methods for the making and use thereof Nov 28, 2026 Marinus
Ztalmy US8367651 Solid ganaxolone formulations and methods for the making and use thereof Nov 28, 2026 Marinus
Ztalmy US8618087 Solid ganaxolone formulations and methods for the making and use thereof Nov 28, 2026 Marinus
Ztalmy US9029355 Solid ganaxolone compositions and methods for the making and use thereof Nov 28, 2026 Marinus
Ztalmy US9056116 Liquid ganaxolone formulations and methods for the making and use thereof Nov 28, 2026 Marinus


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ganaxolone's patents.

Given below is the list recent legal activities going on the following patents of Ganaxolone.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 11 Jul, 2024 US8367651
Payment of Maintenance Fee, 12th Yr, Small Entity 11 Apr, 2024 US8318714
Second letter to regulating agency to determine regulatory review period 30 Sep, 2023 US8318714
Letter from FDA or Dept of Agriculture re PTE application 28 Sep, 2023 US8318714
Payment of Maintenance Fee, 4th Year, Large Entity 10 Aug, 2023 US10603308
Payment of Maintenance Fee, 12th Year, Large Entity 28 Feb, 2023 US8022054
Payment of Maintenance Fee, 8th Year, Large Entity 24 Nov, 2022 US9056116
Payment of Maintenance Fee, 8th Year, Large Entity 07 Nov, 2022 US9029355
Letter re PTE application to FDA or Dept of Agriculture 08 Jul, 2022 US8318714
Payment of Maintenance Fee, 12th Yr, Small Entity 08 Jun, 2022 US7858609



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