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 Immedica Pharma Ab
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 | US12115169 | Ganaxolone For Use In Treating Tuberous Sclerosis Complex And Seizure Disorders | Sep 30, 2042 | Immedica Pharma |
| Ztalmy | US12268696 | Ganaxolone For Use In Treating Tuberous Sclerosis Complex And Seizure Disorders | Sep 30, 2042 | Immedica Pharma |
| Ztalmy | US10603308 | Methods and compositions for treatment of epileptic disorders | Aug 10, 2037 | Immedica Pharma |
| Ztalmy | US12144801 | Methods and compositions for treatment of epileptic disorders | Aug 10, 2037 | Immedica Pharma |
| Ztalmy | US8318714 | Liquid ganaxolone formulations and methods for the making and use thereof | Nov 28, 2031 | Immedica Pharma |
| Ztalmy | US7858609 | Solid ganaxolone formulations and methods for the making and use thereof | Nov 28, 2026 | Immedica Pharma |
| Ztalmy | US8022054 | Liquid ganaxolone formulations and methods for the making and use thereof | Nov 28, 2026 | Immedica Pharma |
| Ztalmy | US8367651 | Solid ganaxolone formulations and methods for the making and use thereof | Nov 28, 2026 | Immedica Pharma |
| Ztalmy | US8618087 | Solid ganaxolone formulations and methods for the making and use thereof | Nov 28, 2026 | Immedica Pharma |
| Ztalmy | US9029355 | Solid ganaxolone compositions and methods for the making and use thereof | Nov 28, 2026 | Immedica Pharma |
| Ztalmy | US9056116 | Liquid ganaxolone formulations and methods for the making and use thereof | Nov 28, 2026 | Immedica Pharma |
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.
Latest Legal Activities on Ganaxolone's Patents
Given below is the list recent legal activities going on the following patents of Ganaxolone.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate | 17 Feb, 2026 | US8318714 |
| Change in Power of Attorney (May Include Associate POA) | 26 Sep, 2025 | US10603308 |
| Email Notification | 26 Sep, 2025 | US10603308 |
| Notice of Final Determination -Eligible | 05 Jun, 2025 | US8318714 |
| Information Disclosure Statement (IDS) Filed | 20 May, 2025 | US8318714 |
| FDA Final Eligibility Letter | 20 May, 2025 | US8318714 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 08 May, 2025 | US8618087 |
| transaction for FDA Determination of Regulatory Review Period | 11 Sep, 2024 | US8318714 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Jul, 2024 | US8367651 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 11 Apr, 2024 | US8318714 |
Ganaxolone's Family Patents
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Clinical Trials
Recent Clinical Trials on Ganaxolone:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old | Immedica Pharma AB | NA |
NOT YET RECRUITING
(Aug 1, 2026)
| PHASE3 |
| Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism | Stanford University | NA |
NOT YET RECRUITING
(Jun 1, 2026)
| PHASE2 |