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FDA Orange Book · active-ingredient family

Glycerol phenylbutyrate

Glycerol phenylbutyrate: 1 brand, 7 generics; first approved Feb 01, 2013; generic available.

Generic available1 exclusivity period
Generic status & protection

Generic available: 7 ANDA applications approved.

Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
14
Next patent expiry
Sep 22, 2030
in 4 yr

Brand (NDA) products

Originator applications
  • RAVICTIRLDRS
    NDA 2032842013
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA

Generic (ANDA) products (7)

Abbreviated applications
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2205792026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2076942026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2205682026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2203132026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2195402026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2187382026
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA
  • GLYCEROL PHENYLBUTYRATE
    ANDA 2057422021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    1.1GM/MLLIQUIDORALRxAA

Patent & exclusivity timeline

Protection horizon
202620272028202920302031TodayExclusivity PC: 2026-04-15Exclusivity PCPatent 9962359: 2030-09-22Patent 9962359Patent 9561197: 2030-09-22Patent 9561197Patent 10183003: 2030-09-22Patent 10183003Patent 10183002: 2030-09-22Patent 10183002Patent 10183004: 2030-09-22Patent 10183004Patent 8642012: 2030-09-22Patent 8642012Patent 10045959: 2030-09-22Patent 10045959Patent 9999608: 2030-09-22Patent 9999608Patent 9326966: 2030-09-22Patent 9326966Patent 10668040: 2030-09-22Patent 10668040Patent 10183005: 2030-09-22Patent 10183005Patent 10183006: 2030-09-22Patent 10183006Patent 10045958: 2030-09-22Patent 10045958Patent 9254278: 2030-09-22Patent 9254278
Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman
  • PCPatent-challenge (180-day generic) exclusivity

    6 mo ago

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9962359in 4 yr
U-1816
9561197in 4 yr
U-1383
10183003in 4 yr
U-1816
10183002in 4 yr
U-1816
10183004in 4 yr
U-1816
8642012in 4 yr
U-1383
10045959in 4 yr
U-1816
9999608in 4 yr
U-1816
9326966in 4 yr
U-1816
10668040in 4 yr
U-1816
10183005in 4 yr
U-1816
10183006in 4 yr
U-1816
10045958in 4 yr
U-1816
9254278in 4 yr
U-1816

Approval history

FDA approval span
First approval
13 yr 11 mo ago
Most recent approval
3 mo ago

Approvals span 2013–2026 across 8 FDA applications.

Brand (NDA) 113%
Generic (ANDA) 788%

Glycerol phenylbutyrate: 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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