Fintepla is a drug owned by Ucb Inc. It is protected by 28 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 29, 2038. Details of Fintepla's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US10947183 | Fenfluramine compositions and methods of preparing the same |
Dec, 2036
(12 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10478442 | Method for the treatment of Dravet Syndrome |
May, 2033
(8 years from now) | Active |
| US9603815 | Method for the treatment of Dravet syndrome |
May, 2033
(8 years from now) | Active |
| US9549909 | Method for the treatment of dravet syndrome |
May, 2033
(8 years from now) | Active |
| US10478441 | Method for the treatment of Dravet syndrome |
May, 2033
(8 years from now) | Active |
| US9610260 | Method for the treatment of Dravet Syndrome |
May, 2033
(8 years from now) | Active |
| US9603814 | Method for the treatment of Dravet syndrome |
May, 2033
(8 years from now) | Active |
|
US9549909 (Pediatric) | Method for the treatment of dravet syndrome |
Nov, 2033
(9 years from now) | Active |
|
US10478441 (Pediatric) | Method for the treatment of Dravet syndrome |
Nov, 2033
(9 years from now) | Active |
|
US10478442 (Pediatric) | Method for the treatment of Dravet Syndrome |
Nov, 2033
(9 years from now) | Active |
|
US9603814 (Pediatric) | Method for the treatment of Dravet syndrome |
Nov, 2033
(9 years from now) | Active |
|
US9610260 (Pediatric) | Method for the treatment of Dravet Syndrome |
Nov, 2033
(9 years from now) | Active |
|
US9603815 (Pediatric) | Method for the treatment of Dravet syndrome |
Nov, 2033
(9 years from now) | Active |
| US10950331 | Control system for control of distribution of medication |
Sep, 2035
(11 years from now) | Active |
|
US10950331 (Pediatric) | Control system for control of distribution of medication |
Mar, 2036
(11 years from now) | Active |
|
US10947183 (Pediatric) | Fenfluramine compositions and methods of preparing the same |
Jun, 2037
(12 years from now) | Active |
| US10603290 | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Aug, 2037
(13 years from now) | Active |
| US11759440 | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Aug, 2037
(13 years from now) | Active |
| US11786487 | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Aug, 2037
(13 years from now) | Active |
| US11406606 | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Aug, 2037
(13 years from now) | Active |
| US11040018 | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Aug, 2037
(13 years from now) | Active |
|
US11406606 (Pediatric) | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Feb, 2038
(13 years from now) | Active |
|
US11759440 (Pediatric) | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Feb, 2038
(13 years from now) | Active |
|
US10603290 (Pediatric) | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Feb, 2038
(13 years from now) | Active |
|
US11040018 (Pediatric) | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Feb, 2038
(13 years from now) | Active |
|
US11786487 (Pediatric) | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same |
Feb, 2038
(13 years from now) | Active |
| US10452815 | Control system for control of distribution of medication |
Jun, 2038
(13 years from now) | Active |
|
US10452815 (Pediatric) | Control system for control of distribution of medication |
Dec, 2038
(14 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 Fintepla's patents.
Latest Legal Activities on Fintepla's Patents
Given below is the list of recent legal activities going on the following patents of Fintepla.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jul, 2024 | US9549909 |
| Post Issue Communication - Certificate of Correction | 03 Jan, 2024 | US11759440 |
| Post Issue Communication - Certificate of Correction | 03 Jan, 2024 | US11786487 |
| Recordation of Patent eGrant | 17 Oct, 2023 | US11786487 |
| Recordation of Patent Grant Mailed | 17 Oct, 2023 | US11786487 |
| Patent Issue Date Used in PTA Calculation | 17 Oct, 2023 | US11786487 |
| Patent eGrant Notification | 17 Oct, 2023 | US11786487 |
| Email Notification | 17 Oct, 2023 | US11786487 |
| Mail Patent eGrant Notification | 17 Oct, 2023 | US11786487 |
| Email Notification | 28 Sep, 2023 | US11786487 |
FDA has granted several exclusivities to Fintepla. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Fintepla, 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 Fintepla.
Exclusivity Information
Fintepla holds 5 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Fintepla's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 25, 2023 |
| New Indication(I-887) | Mar 25, 2025 |
| Orphan Drug Exclusivity(ODE-312) | Jun 25, 2027 |
| Orphan Drug Exclusivity(ODE-393) | Mar 25, 2029 |
| Pediatric Exclusivity(PED) | Sep 25, 2029 |
Several oppositions have been filed on Fintepla'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 Fintepla's generic, the next section provides detailed information on ongoing and past EP oppositions related to Fintepla patents.
Fintepla's oppositions filed in EPO
Fintepla has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 05, 2018, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP14724037A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15813093A | Jul, 2022 | Elkington and Fife LLP | Granted and Under Opposition |
| EP18152406A | Dec, 2021 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
| EP18152406A | Nov, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP16879990A | Sep, 2021 | OLON S.p.A. | Granted and Under Opposition |
| EP16879990A | Sep, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP14724037A | Dec, 2018 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Fintepla 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 Fintepla's family patents as well as insights into ongoing legal events on those patents.
Fintepla's family patents
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Generic Launch
Generic Release Date:
Fintepla's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 29, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fintepla Generics:
There are no approved generic versions for Fintepla as of now.
How can I launch a generic of Fintepla before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fintepla's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fintepla'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 Fintepla -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.2 mg/mL | 21 Jun, 2021 | 1 | 29 Jun, 2038 |
About Fintepla
Fintepla is a drug owned by Ucb Inc. It is used for reducing or ameliorating seizures in patients with Dravet or Lennox-Gastaut syndrome through various combination therapies and cardiac monitoring to mitigate cardiovascular risk. Fintepla uses Fenfluramine Hydrochloride as an active ingredient. Fintepla was launched by Ucb Inc in 2020.
Market Authorisation Date:
Fintepla was approved by FDA for market use on 25 June, 2020.
Active Ingredient:
Fintepla uses Fenfluramine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fenfluramine Hydrochloride ingredient
Treatment:
Fintepla is used for reducing or ameliorating seizures in patients with Dravet or Lennox-Gastaut syndrome through various combination therapies and cardiac monitoring to mitigate cardiovascular risk.
Dosage:
Fintepla is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2.2MG BASE/ML | SOLUTION | Prescription | ORAL |