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FDA Orange Book · active-ingredient family

Fenfluramine hydrochloride

Fenfluramine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:FINTEPLA · NDA 212102

1

Brand (NDA)

0

Generics (ANDA)

28

Listed patents

4

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
FINTEPLARLDUCB INCNDA 212102—Jun 25, 2020

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 10 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 4 mo

Listed patents (28)

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

Fenfluramine hydrochloride — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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