Is there a generic for Glycerol phenylbutyrate?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Glycerol phenylbutyrate, referencing the brand RAVICTI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Glycerol phenylbutyrate?

RAVICTI (NDA 203284, HORIZON THERAP US) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Glycerol phenylbutyrate?

The Orange Book lists 14 patents against Glycerol phenylbutyrate products, with the earliest listed expiry in 2030. 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 Glycerol phenylbutyrate have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Glycerol phenylbutyrate. 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 Glycerol phenylbutyrate are approved?

Glycerol phenylbutyrate is approved in the following dosage form: liquid.

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 Sep 22, 2030Latest exclusivity ends Apr 15, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 22, 2030

in 4 yr 1 mo

Brand (NDA) products

Originator applications

RAVICTIRLDRS
HORIZON THERAP USNDA 2032842013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Generic (ANDA) products (7)

Abbreviated applications

GLYCEROL PHENYLBUTYRATE
ESJAY PHARMAANDA 2205792026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA
GLYCEROL PHENYLBUTYRATE
LUPINANDA 2076942026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA
GLYCEROL PHENYLBUTYRATE
NAVINTA LLCANDA 2205682026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA
GLYCEROL PHENYLBUTYRATE
AUROBINDO PHARMAANDA 2203132026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA
GLYCEROL PHENYLBUTYRATE
MSNANDA 2195402026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA
GLYCEROL PHENYLBUTYRATE
TEVA PHARMS INCANDA 2187382026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA
GLYCEROL PHENYLBUTYRATE
PH HEALTHANDA 2057422021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.1GM/ML LIQUID ORAL Rx AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.1GM/ML	LIQUID	ORAL	Rx	AA

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

PCPatent-challenge (180-day generic) exclusivity
Apr 15, 2026
5 mo ago

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9962359	Sep 22, 2030	in 4 yr 1 mo	U-1816
9561197	Sep 22, 2030	in 4 yr 1 mo	U-1383
10183003	Sep 22, 2030	in 4 yr 1 mo	U-1816
10183002	Sep 22, 2030	in 4 yr 1 mo	U-1816
10183004	Sep 22, 2030	in 4 yr 1 mo	U-1816
8642012	Sep 22, 2030	in 4 yr 1 mo	U-1383
10045959	Sep 22, 2030	in 4 yr 1 mo	U-1816
9999608	Sep 22, 2030	in 4 yr 1 mo	U-1816
9326966	Sep 22, 2030	in 4 yr 1 mo	U-1816
10668040	Sep 22, 2030	in 4 yr 1 mo	U-1816
10183005	Sep 22, 2030	in 4 yr 1 mo	U-1816
10183006	Sep 22, 2030	in 4 yr 1 mo	U-1816
10045958	Sep 22, 2030	in 4 yr 1 mo	U-1816
9254278	Sep 22, 2030	in 4 yr 1 mo	U-1816

Approval history

FDA approval span

First approval

Feb 01, 2013

13 yr 10 mo ago

Most recent approval

Jul 28, 2026

2 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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