Fycompa is a drug owned by Catalyst Pharmaceuticals Inc. It is protected by 2 US drug patents filed from 2013 to 2016 out of which none have expired yet. Fycompa's patents have been open to challenges since 22 October, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2026. Details of Fycompa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8772497 | Method for producing 1, 2-dihydropyridine-2-one compound |
Jul, 2026
(1 year, 6 months from now) | Active |
| US6949571 | 1,2-dihydropyridine compounds, process for preparation of the same and use thereof |
May, 2025
(4 months 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 Fycompa's patents.
Latest Legal Activities on Fycompa's Patents
Given below is the list of recent legal activities going on the following patents of Fycompa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 11 Mar, 2024 | US6949571 |
| PTE Interim Patent Extension filed Critical | 29 Feb, 2024 | US6949571 |
| Patent Term Extension (156) Dismissed Critical | 27 Jun, 2023 | US6949571 |
| Interim Patent Term Extension Granted Critical | 17 May, 2023 | US6949571 |
| Filing Receipt - Corrected | 02 Mar, 2023 | US8772497 |
| Email Notification Critical | 02 Mar, 2023 | US8772497 |
| Correspondence Address Change Critical | 27 Feb, 2023 | US6949571 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 Feb, 2023 | US8772497 |
| Interim Patent Term Extension Granted Critical | 25 May, 2022 | US6949571 |
| FDA Final Eligibility Letter Critical | 06 Apr, 2022 | US6949571 |
FDA has granted several exclusivities to Fycompa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fycompa, 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 Fycompa.
Exclusivity Information
Fycompa holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Fycompa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 22, 2017 |
| New Indication(I-710) | Jun 19, 2018 |
US patents provide insights into the exclusivity only within the United States, but Fycompa 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 Fycompa's family patents as well as insights into ongoing legal events on those patents.
Fycompa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fycompa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fycompa Generic API suppliers:
Perampanel is the generic name for the brand Fycompa. 2 different companies have already filed for the generic of Fycompa, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fycompa's generic
How can I launch a generic of Fycompa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fycompa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fycompa'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 Fycompa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg/mL | 20 Dec, 2022 | 1 | 01 Jul, 2026 | ||
| 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg | 24 Oct, 2016 | 2 | 01 Jul, 2026 |
Alternative Brands for Fycompa
Fycompa which is used for controlling seizures in patients with epilepsy., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Abbvie |
| |||
| Eisai Inc |
| |||
| Supernus Pharms |
| |||
About Fycompa
Fycompa is a drug owned by Catalyst Pharmaceuticals Inc. It is used for controlling seizures in patients with epilepsy. Fycompa uses Perampanel as an active ingredient. Fycompa was launched by Catalyst Pharms in 2012.
Approval Date:
Fycompa was approved by FDA for market use on 22 October, 2012.
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 Fycompa is 22 October, 2012, its NCE-1 date is estimated to be 22 October, 2016.
Active Ingredient:
Fycompa uses Perampanel as the active ingredient. Check out other Drugs and Companies using Perampanel ingredient
Treatment:
Fycompa is used for controlling seizures in patients with epilepsy.
Dosage:
Fycompa is available in the following dosage forms - tablet form for oral use, suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 8MG | TABLET | Prescription | ORAL |
| 4MG | TABLET | Prescription | ORAL |
| 6MG | TABLET | Prescription | ORAL |
| 12MG | TABLET | Prescription | ORAL |
| 0.5MG/ML | SUSPENSION | Prescription | ORAL |