Is there a generic for Fenfluramine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Fenfluramine hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Fenfluramine hydrochloride?

FINTEPLA (NDA 212102, UCB INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Fenfluramine hydrochloride?

The Orange Book lists 28 patents against Fenfluramine hydrochloride products, with the earliest listed expiry in 2033. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Fenfluramine hydrochloride have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Fenfluramine hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Fenfluramine hydrochloride are approved?

Fenfluramine hydrochloride is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Fenfluramine hydrochloride

Fenfluramine hydrochloride: 1 brand, 0 generics; first approved Jun 25, 2020; on patent until May 03, 2033.

On patent4 exclusivity periods

Generic status & protection

Protected until May 03, 2033 (earliest listed patent expiry).

Earliest patent expiry May 03, 2033Latest exclusivity ends Sep 25, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 03, 2033

in 6 yr 11 mo

Originator applications

Brand (NDA) products

FINTEPLARLDRS

UCB INCNDA 2121022020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.2MG BASE/ML	SOLUTION	ORAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (4)

ODE-312Orphan-drug exclusivity (7 years)
Jun 25, 2027
in 1 yr
ODE-393Orphan-drug exclusivity (7 years)
Mar 25, 2029
in 2 yr 9 mo
PEDPediatric exclusivity (adds 6 months)
Dec 25, 2027
in 1 yr 6 mo
PEDPediatric exclusivity (adds 6 months)
Sep 25, 2029
in 3 yr 3 mo

Orange Book patent file

Listed patents

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9603815	May 03, 2033	in 6 yr 11 mo	U-2858
9549909	May 03, 2033	in 6 yr 11 mo	U-2858
9610260	May 03, 2033	in 6 yr 11 mo	U-2858
9603814	May 03, 2033	in 6 yr 11 mo	U-2858
10478442	May 03, 2033	in 6 yr 11 mo	U-2860
10478441	May 03, 2033	in 6 yr 11 mo	U-2860
12097206	May 03, 2033	in 6 yr 11 mo	U-4013
9603815*PED	Nov 03, 2033	in 7 yr 5 mo
9549909*PED	Nov 03, 2033	in 7 yr 5 mo
9610260*PED	Nov 03, 2033	in 7 yr 5 mo
9603814*PED	Nov 03, 2033	in 7 yr 5 mo
10478442*PED	Nov 03, 2033	in 7 yr 5 mo
10478441*PED	Nov 03, 2033	in 7 yr 5 mo
12097206*PED	Nov 03, 2033	in 7 yr 5 mo
10947183	Dec 20, 2036	in 10 yr 7 mo	SubstanceProduct
10947183*PED	Jun 20, 2037	in 11 yr 1 mo
10603290	Aug 02, 2037	in 11 yr 3 mo	U-2861
11759440	Aug 02, 2037	in 11 yr 3 mo	U-3694
11040018	Aug 02, 2037	in 11 yr 3 mo	U-2861
11406606	Aug 02, 2037	in 11 yr 3 mo	U-3406
11786487	Aug 02, 2037	in 11 yr 3 mo	U-3733
11759440*PED	Feb 02, 2038	in 11 yr 9 mo
11406606*PED	Feb 02, 2038	in 11 yr 9 mo
10603290*PED	Feb 02, 2038	in 11 yr 9 mo
11040018*PED	Feb 02, 2038	in 11 yr 9 mo
11786487*PED	Feb 02, 2038	in 11 yr 9 mo
10452815	Jun 29, 2038	in 12 yr 2 mo	U-2859Delisted
10452815*PED	Dec 29, 2038	in 12 yr 8 mo

FDA approval span

Approval history

First approval

Jun 25, 2020

6 yr 2 mo ago

Most recent approval

Jun 25, 2020

6 yr 2 mo ago

All 1 application were approved in 2020.

Brand (NDA) 1100%

Generic (ANDA) 00%

Fenfluramine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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