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FINTEPLA

NDA

FENFLURAMINE HYDROCHLORIDE | N212102 | UCB INC

1 strength14 unique patents3 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

2037

2038

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

Dec. 25, 2027

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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome NCT07503444	Phase 3	Not Yet Recruiting	UCB BIOSCIENCES, Inc.	200	2026-06-30 → 2030-11-15

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

Medicare Part D Spending

CMS annual spending data for Fintepla (2023)

Total Spending

$18.0M

Total Claims

1,166

Beneficiaries

160

Avg Cost/Unit

$53.09

Spending Trend

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

YoY Change:+6.3%

5yr CAGR:+5.9%

Source: CMS Medicare Part D Spending by Drug (2023). 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 patents3 exclusivities▴

SOLUTION;ORAL | Approved: Jun 25, 2020

Patents (14)

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 (3)

Code	Date	Status
ODE-312	Jun 25, 2027	< 1 year
ODE-393	Mar 25, 2029	Active
PED	Dec 25, 2027	Active