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FINTEPLA

NDA

FENFLURAMINE HYDROCHLORIDE | N212102 | UCB INC

1 strength14 unique patents6 unique exclusivities

Patent Timeline

14 unique patents (1 delisted), 2 exclusivities by expiration date

Active (14)TodayPED (+6 mo)ExclusivityDelisted

1 patent delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2039

Today

Nov. 3, 2033

Nov. 3, 2033

Nov. 3, 2033

Nov. 3, 2033

Nov. 3, 2033

Nov. 3, 2033

Feb. 2, 2038

Jun. 20, 2037

Feb. 2, 2038

Feb. 2, 2038

Feb. 2, 2038

Feb. 2, 2038

Nov. 3, 2033

Dec. 29, 2038Delisted

ODE-312

Dec. 25, 2027

ODE-393

Sep. 25, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Zogenix, Inc. et al v. Apotex Inc. et al 1:2022cv01232	D. Del.	2022-09-21	Terminated 2023-11-28	—
Zogenix, Inc. et al v. Apotex Inc. et al 1:2021cv01533 2 patentsANDA 216108fenfluramine hydrochloride	D. Del.	2021-10-28	Terminated 2023-11-28	—
Zogenix, Inc. et al v. Lupin Ltd. 1:2021cv01424 7 patentsANDA 216218fenfluramine hydrochloride	D. Del.	2021-10-06	Terminated 2023-11-08	—
Zogenix, Inc. et al v. Apotex Inc. et al 1:2021cv01252 2 patentsANDA 216108fenfluramine hydrochloride	D. Del.	2021-08-30	Terminated 2023-11-28	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

8 trials from ClinicalTrials.gov — 1 recruiting, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Refractory Infantile Spasms With Fenfluramine NCT04289467	Phase 2	Recruiting	Children's Hospital of Orange County	10	2023-06-16 → 2026-12-31
ZX008 Expanded Access Protocol NCT03780127	—	APPROVED_FOR_MARKETING	Zogenix, Inc.	—	—
Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).NCT03790137	Phase 3	Completed	Elizabeth Anne Thiele	20	2019-05-31 → 2024-07-19
Cardiovascular System in Obesity: Effect of Treatment NCT00000506	Phase 2	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1983-05 → 1988-04
Investigation of Serotonin Neurotransmission in MDMA Users Using Combinated Dexfenfluramine Challenge and PET Imaging NCT01296802	N/A	Completed	University of Zurich	50	2006-04 → 2008-07
Fenfluramine in CDKL5 Deficiency Disorder (CDD)NCT03861871	Phase 2	Completed	NYU Langone Health	7	2019-10-29 → 2022-10-24
Predictive Values of Serotonergic Alterations for Outcome - 2 NCT00000313	Phase 1	Terminated	National Institute on Drug Abuse (NIDA)	—	—
Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy NCT02655198	Phase 2	UNKNOWN	KU Leuven	13	2016-01 → 2024-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1242.51

Highest Price

$17750.56

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43376-0322-30FINTEPLA 2.2MG/ML SOLN,ORAL	$1479.22	FSS	UCB, Inc.	09/14/2030
43376-0322-30FINTEPLA 2.2MG/ML SOLN,ORAL	$1242.51	Big4	UCB, Inc.	09/14/2030
43376-0322-36FINTEPLA 2.2MG/ML SOLN,ORAL	$17750.56	FSS	UCB, Inc.	09/14/2030
43376-0322-36FINTEPLA 2.2MG/ML SOLN,ORAL	$14780.87	Big4	UCB, Inc.	09/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Fintepla (2024)

Total Spending

$40.9M

Total Claims

2,456

Beneficiaries

292

Avg Cost/Unit

$55.08

Spending Trend

$225K(2020)→$1.8M(2021)→$7.2M(2022)→$18.0M(2023)→$40.9M(2024)

YoY Change:+3.8%

5yr CAGR:+5.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

MAITHRI DRUGS PRIVATE LTDFENFLURAMINE HYDROCHLORIDE

DMF 348972020

OLON SPAFENFLURAMINE HYDROCHLORIDE

DMF 353392020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFENFLURAMINE HYDROCHLORIDE

DMF 373212022

LABORATORI MAG SPAInactiveFENFLURAMINE HYDROCHLORIDE

DMF 119461996

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveFENFLURAMINE HYDROCHLORIDE

DMF 120561996

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
May 27, 2026	SUPPL -18	View Letter (PDF)
Oct 16, 2025	SUPPL -17	View Letter (PDF)
Apr 9, 2025	SUPPL -16	View Letter (PDF)
Apr 3, 2024	SUPPL -14	View Letter (PDF)
Dec 12, 2023	SUPPL -13	View Letter (PDF)
Sep 15, 2023	SUPPL -8	View Letter (PDF)
Sep 15, 2023	SUPPL -7	View Letter (PDF)
May 31, 2023	SUPPL -9	View Letter (PDF)
Jan 4, 2023	SUPPL -6	View Letter (PDF)
Jun 16, 2022	SUPPL -5	View Letter (PDF)
Mar 28, 2022	SUPPL -3	View Letter (PDF)
Nov 16, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2.2MG BASE/ML

RLD

14 patents6 exclusivities▴

SOLUTION;ORAL | Approved: Jun 25, 2020

Patents (14) · 16 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9549909	May 3, 2033PED: Nov 3, 2033	PED	—	—		—
9603814	May 3, 2033PED: Nov 3, 2033	PED	—	—		—
9603815	May 3, 2033PED: Nov 3, 2033	PED	—	—		—
9610260	May 3, 2033PED: Nov 3, 2033	PED	—	—		—
10452815	Jun 29, 2038PED: Dec 29, 2038	PED	—	—		Delisted
10478441	May 3, 2033PED: Nov 3, 2033	PED	—	—		—
10478442	May 3, 2033PED: Nov 3, 2033	PED	—	—		—
10603290	Aug 2, 2037PED: Feb 2, 2038	PED	—	—		—
10947183	Dec 20, 2036PED: Jun 20, 2037	PED	Yes	Yes	—	—
11040018	Aug 2, 2037PED: Feb 2, 2038	PED	—	—		—
11406606	Aug 2, 2037PED: Feb 2, 2038	PED	—	—		—
11759440	Aug 2, 2037PED: Feb 2, 2038	PED	—	—		—
11786487	Aug 2, 2037PED: Feb 2, 2038	PED	—	—		—
12097206	May 3, 2033PED: Nov 3, 2033	PED	—	—		—

Exclusivities (6)

Code	Date	Status
ODE-312	Jun 25, 2027	< 1 year
ODE-393	Mar 25, 2029	Active
PED	Dec 25, 2027	Active
PED	Sep 25, 2029	Active
ODE-312*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Dec 25, 2027	Active
ODE-393*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Sep 25, 2029	Active

Change History (2)

Recent changes detected for this application.

ADDED7/14/2026

FINTEPLA (fenfluramine hydrochloride) gained pediatric exclusivity expiring Dec 2027 under the Orphan Drug Exclusivity program.

New: FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — exclusivity ODE-312*PED exp 12/25/2027

ADDED7/14/2026

FINTEPLA (fenfluramine hydrochloride) gained pediatric exclusivity expiring Sep 2029 following orphan drug designation completion.

New: FINTEPLA (FENFLURAMINE HYDROCHLORIDE) — exclusivity ODE-393*PED exp 09/25/2029