Filspari is a drug owned by Travere Therapeutics Inc. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Filspari's patents will be open to challenges from 17 February, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 05, 2031. Details of Filspari'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). | |||
| US9993461 | Method for treating disorders associated with glomerular function |
Mar, 2030
(4 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 Filspari's patents.
Latest Legal Activities on Filspari's Patents
Given below is the list of recent legal activities going on the following patents of Filspari.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 08 May, 2024 | US9993461 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US9993461 |
| Initial letter Re: PTE Application to regulating agency | 17 Nov, 2023 | US9993461 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 12 Sep, 2023 | US9993461 |
| Requirement for information sent under 37 CFR 1.750 | 04 Aug, 2023 | US9993461 |
| Patent Term Extension Application under 35 USC 156 Filed | 14 Apr, 2023 | US9993461 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 13 Dec, 2021 | US9993461 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jun, 2018 | US9993461 |
| Recordation of Patent Grant Mailed Critical | 12 Jun, 2018 | US9993461 |
| Email Notification Critical | 24 May, 2018 | US9993461 |
FDA has granted several exclusivities to Filspari. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Filspari, 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 Filspari.
Exclusivity Information
Filspari holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Filspari's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 17, 2028 |
| Orphan Drug Exclusivity(ODE-389) | Feb 17, 2030 |
| Orphan Drug Exclusivity(ODE-493) | Sep 05, 2031 |
Several oppositions have been filed on Filspari's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Filspari's generic, the next section provides detailed information on ongoing and past EP oppositions related to Filspari patents.
Filspari's Oppositions Filed in EPO
Filspari has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 23, 2020, by Pajaro Limited. This opposition was filed on patent number EP17157697A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17157697A | Nov, 2020 | Pajaro Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Filspari 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 Filspari's family patents as well as insights into ongoing legal events on those patents.
Filspari's Family Patents
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Generic Launch
Generic Release Date:
Filspari's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 05, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Filspari Generics:
There are no approved generic versions for Filspari as of now.
About Filspari
Filspari is a drug owned by Travere Therapeutics Inc. It is used for slowing the progression of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. Filspari uses Sparsentan as an active ingredient. Filspari was launched by Travere in 2023.
Approval Date:
Filspari was approved by FDA for market use on 17 February, 2023.
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 Filspari is 17 February, 2023, its NCE-1 date is estimated to be 17 February, 2027.
Active Ingredient:
Filspari uses Sparsentan as the active ingredient. Check out other Drugs and Companies using Sparsentan ingredient
Treatment:
Filspari is used for slowing the progression of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression.
Dosage:
Filspari is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |
| 400MG | TABLET | Prescription | ORAL |