RAVICTI

203284 | Orange Book

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Filed Feb. 1, 2013
Type New Drug Application
Case Type New Drug Application
Ingredients GLYCEROL PHENYLBUTYRATE
Dosage Form / Route ORAL and LIQUID
PatentExpiration
10,045,9585 years, 5 months from now
10,045,9595 years, 5 months from now
10,183,0025 years, 5 months from now
10,183,0035 years, 5 months from now
10,183,0045 years, 5 months from now
10,183,0055 years, 5 months from now
10,183,0065 years, 5 months from now
10,668,0405 years, 5 months from now
8,642,0125 years, 5 months from now
9,561,1975 years, 5 months from now
9,962,3595 years, 5 months from now
9,999,6085 years, 5 months from now
8,404,2156 years, 10 months from now
9,095,5596 years, 10 months from now
9,254,2786 years, 10 months from now
9,326,9666 years, 10 months from now
Last Updated: 2 years, 8 months ago
Date Patent / Filing No. Patent and Drug Application Information
3/9/20329326966Expiration of Patent No 9,326,966: (U-1816).
3/9/20329254278Expiration of Patent No 9,254,278: (U-1816).
3/9/20329095559Expiration of Patent No 9,095,559: (U-1383).
3/9/20328404215Expiration of Patent No 8,404,215: (U-1383).
9/22/20309999608Expiration of Patent No 9,999,608: (U-1816).
9/22/20309962359Expiration of Patent No 9,962,359: (U-1816).
9/22/20309561197Expiration of Patent No 9,561,197: (U-1383).
9/22/20308642012Expiration of Patent No 8,642,012: (U-1383).
9/22/203010668040Expiration of Patent No 10,668,040: (U-1816).
9/22/203010183006Expiration of Patent No 10,183,006: (U-1816).
9/22/203010183005Expiration of Patent No 10,183,005: (U-1816).
9/22/203010183004Expiration of Patent No 10,183,004: (U-1816).
9/22/203010183003Expiration of Patent No 10,183,003: (U-1816).
9/22/203010183002Expiration of Patent No 10,183,002: (U-1816).
9/22/203010045959Expiration of Patent No 10,045,959: (U-1816).
9/22/203010045958Expiration of Patent No 10,045,958: (U-1816).
9/3/2021SUPPL-12Labeling-Medication Guide, Labeling-Package Insert:
10/4/2019SUPPL-11Efficacy-Labeling Change With Clinical Data:
12/21/2018SUPPL-10Efficacy-Labeling Change With Clinical Data:
4/28/2017SUPPL-5Efficacy-New Patient Population:
9/8/2016SUPPL-4Efficacy-Labeling Change With Clinical Data:
7/27/2015SUPPL-3Manufacturing (CMC): Label is not available on this site.
    1/5/2015SUPPL-2Manufacturing (CMC): Label is not available on this site.
      6/24/2014SUPPL-1Labeling-Package Insert:
      2/1/2013
      Approval for RAVICTI, 1.1GM/ML
      • Reference Drug
      • Active Ingredient: GLYCEROL PHENYLBUTYRATE
      • Dosage Form: LIQUID
      • Dosage Route: ORAL
      • Therapeutic Equivalence:
      2/1/2013ORIG-1Approval: