Fenfluramine Hydrochloride Patent Expiration

Fenfluramine Hydrochloride 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. It was first introduced by Ucb Inc in its drug Fintepla on Jun 25, 2020.


Fenfluramine Hydrochloride Patents

Given below is the list of patents protecting Fenfluramine Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Fintepla US10452815

(Pediatric)

Control system for control of distribution of medication Dec 29, 2038 Ucb Inc
Fintepla US10452815 Control system for control of distribution of medication Jun 29, 2038 Ucb Inc
Fintepla US10603290

(Pediatric)

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Feb 02, 2038 Ucb Inc
Fintepla US11040018

(Pediatric)

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Feb 02, 2038 Ucb Inc
Fintepla US11406606

(Pediatric)

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Feb 02, 2038 Ucb Inc
Fintepla US11759440

(Pediatric)

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Feb 02, 2038 Ucb Inc
Fintepla US11786487

(Pediatric)

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Feb 02, 2038 Ucb Inc
Fintepla US10603290 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Aug 02, 2037 Ucb Inc
Fintepla US11040018 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Aug 02, 2037 Ucb Inc
Fintepla US11406606 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Aug 02, 2037 Ucb Inc
Fintepla US11759440 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Aug 02, 2037 Ucb Inc
Fintepla US11786487 Formulation for inhibiting formation of 5-HT2B agonists and methods of using same Aug 02, 2037 Ucb Inc
Fintepla US10947183

(Pediatric)

Fenfluramine compositions and methods of preparing the same Jun 20, 2037 Ucb Inc
Fintepla US10947183 Fenfluramine compositions and methods of preparing the same Dec 20, 2036 Ucb Inc
Fintepla US10950331

(Pediatric)

Control system for control of distribution of medication Mar 28, 2036 Ucb Inc
Fintepla US10950331 Control system for control of distribution of medication Sep 28, 2035 Ucb Inc
Fintepla US10478441

(Pediatric)

Method for the treatment of Dravet syndrome Nov 03, 2033 Ucb Inc
Fintepla US10478442

(Pediatric)

Method for the treatment of Dravet Syndrome Nov 03, 2033 Ucb Inc
Fintepla US12097206

(Pediatric)

Method for the treatment of Dravet Syndrome Nov 03, 2033 Ucb Inc
Fintepla US9549909

(Pediatric)

Method for the treatment of dravet syndrome Nov 03, 2033 Ucb Inc
Fintepla US9603814

(Pediatric)

Method for the treatment of Dravet syndrome Nov 03, 2033 Ucb Inc
Fintepla US9603815

(Pediatric)

Method for the treatment of Dravet syndrome Nov 03, 2033 Ucb Inc
Fintepla US9610260

(Pediatric)

Method for the treatment of Dravet Syndrome Nov 03, 2033 Ucb Inc
Fintepla US10478441 Method for the treatment of Dravet syndrome May 03, 2033 Ucb Inc
Fintepla US10478442 Method for the treatment of Dravet Syndrome May 03, 2033 Ucb Inc
Fintepla US12097206 Method for the treatment of Dravet Syndrome May 03, 2033 Ucb Inc
Fintepla US9549909 Method for the treatment of dravet syndrome May 03, 2033 Ucb Inc
Fintepla US9603814 Method for the treatment of Dravet syndrome May 03, 2033 Ucb Inc
Fintepla US9603815 Method for the treatment of Dravet syndrome May 03, 2033 Ucb Inc
Fintepla US9610260 Method for the treatment of Dravet Syndrome May 03, 2033 Ucb Inc



Fenfluramine Hydrochloride's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Fenfluramine Hydrochloride:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome UCB BIOSCIENCES, Inc. NA COMPLETED
(Sep 1, 2026)
PHASE3
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome UCB BIOSCIENCES, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE3
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. Zogenix, Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3


Fenfluramine Hydrochloride Generic API Manufacturers

Given below is the list of companies who have filed for Fenfluramine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.