Orange Book product · Generic (ANDA)
GLYCEROL PHENYLBUTYRATE
GLYCEROL PHENYLBUTYRATE
At a glance
Dec 02, 2021
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 02, 2021
4 yr 7 mo ago
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Apr 15, 2026
2 mo ago
Today
Pharmaceutical detail
Active ingredient
GLYCEROL PHENYLBUTYRATE
Strength
1.1GM/ML
Dosage form
LIQUID
Route
ORAL
TE code
AA
Application
ANDA 205742
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GLYCEROL PHENYLBUTYRATE
- 2013RAVICTIBrand (NDA)
NDA 203284 · HORIZON THERAP US
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ANDA 207694 · LUPIN
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ANDA 220568 · NAVINTA LLC
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ANDA 220313 · AUROBINDO PHARMA
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ANDA 219540 · MSN
- 2026GLYCEROL PHENYLBUTYRATEGeneric (ANDA)
ANDA 218738 · TEVA PHARMS INC
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Apr 15, 2026
2 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
