Ztalmy is a drug owned by Marinus Pharmaceuticals Inc. It is protected by 8 US drug patents filed in 2022 out of which none have expired yet. Ztalmy's patents will be open to challenges from 01 June, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 10, 2037. Details of Ztalmy's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10603308 | Methods and compositions for treatment of epileptic disorders |
Aug, 2037
(12 years from now) | Active |
| US9056116 | Liquid ganaxolone formulations and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
| US7858609 | Solid ganaxolone formulations and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
| US8022054 | Liquid ganaxolone formulations and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
| US8367651 | Solid ganaxolone formulations and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
| US9029355 | Solid ganaxolone compositions and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
| US8618087 | Solid ganaxolone formulations and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
| US8318714 | Liquid ganaxolone formulations and methods for the making and use thereof |
Nov, 2026
(2 years from now) | Active |
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 Ztalmy's patents.
Latest Legal Activities on Ztalmy's Patents
Given below is the list of recent legal activities going on the following patents of Ztalmy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 |
FDA has granted several exclusivities to Ztalmy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ztalmy, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ztalmy.
Exclusivity Information
Ztalmy holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Ztalmy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 01, 2027 |
| Orphan Drug Exclusivity(ODE-395) | Jun 01, 2029 |
US patents provide insights into the exclusivity only within the United States, but Ztalmy is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ztalmy's family patents as well as insights into ongoing legal events on those patents.
Ztalmy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ztalmy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 10, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ztalmy Generics:
There are no approved generic versions for Ztalmy as of now.
About Ztalmy
Ztalmy is a drug owned by Marinus Pharmaceuticals Inc. It is used for treating seizures associated with CDKL5 deficiency disorder in patients aged 2 years and older. Ztalmy uses Ganaxolone as an active ingredient. Ztalmy was launched by Marinus in 2022.
Approval Date:
Ztalmy was approved by FDA for market use on 01 June, 2022.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ztalmy is 01 June, 2022, its NCE-1 date is estimated to be 01 June, 2026.
Active Ingredient:
Ztalmy uses Ganaxolone as the active ingredient. Check out other Drugs and Companies using Ganaxolone ingredient
Treatment:
Ztalmy is used for treating seizures associated with CDKL5 deficiency disorder in patients aged 2 years and older.
Dosage:
Ztalmy is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/ML | SUSPENSION | Prescription | ORAL |