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FDA Orange Book · active-ingredient family

Glycerol phenylbutyrate

Glycerol phenylbutyrate is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RAVICTI · NDA 203284

1

Brand (NDA)

6

Generics (ANDA)

15

Listed patents

1

Exclusivity periods

Brand (NDA) products · liquid

ProductApplicantApplicationTEApproved
RAVICTIRLDHORIZON THERAP USNDA 203284AAFeb 01, 2013

Generic (ANDA) products (6)

ProductApplicantApplicationTEApproved
GLYCEROL PHENYLBUTYRATELUPINANDA 207694AAApr 30, 2026
GLYCEROL PHENYLBUTYRATENAVINTA LLCANDA 220568AAApr 23, 2026
GLYCEROL PHENYLBUTYRATEAUROBINDO PHARMAANDA 220313AAApr 15, 2026
GLYCEROL PHENYLBUTYRATEMSNANDA 219540AAApr 15, 2026
GLYCEROL PHENYLBUTYRATETEVA PHARMS INCANDA 218738AAApr 15, 2026
GLYCEROL PHENYLBUTYRATEPH HEALTHANDA 205742AADec 02, 2021

Marketing exclusivity (1)

  • PCPatent-challenge (180-day generic) exclusivity

    Apr 15, 2026

    2 mo ago

Listed patents (15)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9962359Sep 22, 2030in 4 yr 4 mo
U-1816
9561197Sep 22, 2030in 4 yr 4 mo
U-1383
10183003Sep 22, 2030in 4 yr 4 mo
U-1816
10183002Sep 22, 2030in 4 yr 4 mo
U-1816
10183004Sep 22, 2030in 4 yr 4 mo
U-1816
8642012Sep 22, 2030in 4 yr 4 mo
U-1383
10045959Sep 22, 2030in 4 yr 4 mo
U-1816
9999608Sep 22, 2030in 4 yr 4 mo
U-1816
9326966Sep 22, 2030in 4 yr 4 mo
U-1816
10668040Sep 22, 2030in 4 yr 4 mo
U-1816
10183005Sep 22, 2030in 4 yr 4 mo
U-1816
10183006Sep 22, 2030in 4 yr 4 mo
U-1816
10045958Sep 22, 2030in 4 yr 4 mo
U-1816
9254278Sep 22, 2030in 4 yr 4 mo
U-1816
8404215Mar 09, 2032in 5 yr 10 mo
U-1383Delisted

Glycerol phenylbutyrate — frequently asked questions

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

Agent CTA Background

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