phenylbutyrate Oral Solution
- Brand(s)
- Ravicti
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hyperion Therapeutics, Inc. (2013-02-08)
- Oldest Current Product
- 2013-02-28
- License(s)
- NDA
- RxNORM
- ORAL SOLUTION\PHENYLBUTYRATE
- FDAOB
- ORAL\LIQUID\GLYCEROL PHENYLBUTYRATE
- SPL Active
- ORAL\LIQUID\GLYCEROL PHENYLBUTYRATE
- SPL Moiety
- ORAL\LIQUID\GLYCEROL PHENYLBUTYRATE
product(s) by strength(s)
glycerol phenylbutyrate 1100 mg/ml oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 763250100 | Ravicti | NDA | Hyperion Therapeutics, Inc. | 2013-02-28 | GLYCEROL PHENYLBUTYRATE | ORAL | LIQUID | NDA203284 | 73bc6b83-2513-11e1-bfc2-0800200c9a66 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA203284 | RAVICTI | HORIZON THERAPEUTICS INC | 2013-02-01 | p8404215, DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER p8642012, DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER p9095559, DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER p5968979, TREATMENT OF A NITROGEN METAOLISM DISORDER, SUBSTANCE | ORPHAN DRUG EXCLUSIVITY [2020-02-01] NEW ESTER OR SALT OF AN ACTIVE INGREDIENT [2016-02-01] | NDA203284_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA203284_001 | RX | GLYCEROL PHENYLBUTYRATE (1.1GM/ML) | ORAL | LIQUID | True | 2013-02-01 | RAVICTI |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5968979 (view patent) | 2015-02-07 | NDA203284 |
| 2 | p8404215 (view patent) | 2032-03-09 | NDA203284 |
| 3 | p8642012 (view patent) | 2030-09-22 | NDA203284 |
| 4 | p9095559 (view patent) | 2032-03-09 | NDA203284 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | 73bc6b83-2513-11e1-bfc2-0800200c9a66 (view SPL) | These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996 | prescription | Human Prescription | Hyperion Therapeutics, Inc. | 2013-02-08 | 2 | 763250100 |
| 2 | 900e7dc0-9afe-4f50-80de-90567bb78519 (view SPL) | These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI (glycerol phenylbutyrate) Oral Liquid Initial U.S. Approval: 1996 | prescription | Human Prescription | Horizon Pharma, Inc. | 2015-10-07 | 1 | 759870050 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII