Firdapse is a drug owned by Catalyst Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2021 to 2022 out of which none have expired yet. Firdapse's patents have been open to challenges since 28 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 25, 2037. Details of Firdapse'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). | |||
| US10626088 | Determining degradation of 3,4-diaminopyridine |
Feb, 2037
(11 years from now) | Active |
| US10793893 | Methods of administering 3,4-diaminopyridine |
May, 2034
(9 years from now) | Active |
| US11274332 | Methods of administering 3,4-diaminopyridine |
Jun, 2032
(7 years from now) | Active |
| US11274331 | Methods of administering 3,4-diaminopyridine |
Jun, 2032
(7 years from now) | Active |
| US11268128 | Methods of administering 3,4-diaminopyridine |
Jun, 2032
(7 years from now) | Active |
| US11060128 | Methods of administering 3,4-diaminopyridine |
Jun, 2032
(7 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 Firdapse's patents.
Latest Legal Activities on Firdapse's Patents
Given below is the list of recent legal activities going on the following patents of Firdapse.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Mar, 2024 | US10793893 |
| Surcharge for late Payment, Small Entity | 04 Jan, 2024 | US10626088 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 04 Jan, 2024 | US10626088 |
| Maintenance Fee Reminder Mailed Critical | 11 Dec, 2023 | US10626088 |
| Post Issue Communication - Certificate of Correction | 24 Oct, 2022 | US10793893 |
| Email Notification Critical | 06 Oct, 2022 | US10626088 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 Oct, 2022 | US10626088 |
| Correspondence Address Change Critical | 05 Oct, 2022 | US10626088 |
| Electronic Review Critical | 03 Oct, 2022 | US10793893 |
| Email Notification Critical | 01 Oct, 2022 | US10793893 |
FDA has granted several exclusivities to Firdapse. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Firdapse, 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 Firdapse.
Exclusivity Information
Firdapse holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Firdapse's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 28, 2023 |
| New Patient Population(NPP) | Sep 29, 2025 |
| Orphan Drug Exclusivity(ODE-223) | Nov 28, 2025 |
US patents provide insights into the exclusivity only within the United States, but Firdapse 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 Firdapse's family patents as well as insights into ongoing legal events on those patents.
Firdapse's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Firdapse's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 25, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Firdapse Generics:
There are no approved generic versions for Firdapse as of now.
How can I launch a generic of Firdapse before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Firdapse's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Firdapse's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Firdapse -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg | 28 Nov, 2022 | 3 | 25 Feb, 2037 |
About Firdapse
Firdapse is a drug owned by Catalyst Pharmaceuticals Inc. It is used for treating Lambert-Eaton Myasthenic Syndrome. Firdapse uses Amifampridine Phosphate as an active ingredient. Firdapse was launched by Catalyst Pharms in 2018.
Approval Date:
Firdapse was approved by FDA for market use on 28 November, 2018.
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 Firdapse is 28 November, 2018, its NCE-1 date is estimated to be 28 November, 2022.
Active Ingredient:
Firdapse uses Amifampridine Phosphate as the active ingredient. Check out other Drugs and Companies using Amifampridine Phosphate ingredient
Treatment:
Firdapse is used for treating Lambert-Eaton Myasthenic Syndrome.
Dosage:
Firdapse is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | TABLET | Prescription | ORAL |