OLUMIANT

207924 | Orange Book

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Filed May 31, 2018
Type New Drug Application
Case Type New Drug Application
Ingredients BARICITINIB
Dosage Form / Route ORAL and TABLET
PatentExpiration
8,420,6294 years, 1 month from now
8,158,6165 years, 4 months from now
11,045,4747 years, 10 months from now
9,089,5747 years, 10 months from now
Last Updated: 2 years, 5 months ago
Date Patent / Filing No. Patent and Drug Application Information
11/30/20329089574Expiration of Patent No 9,089,574: (U-3372).
11/30/203211045474Expiration of Patent No 11,045,474: (U-3372).
6/8/20308158616Expiration of Patent No 8,158,616: (drug product)
3/10/20298420629Expiration of Patent No 8,420,629: (U-247).
6/13/2022SUPPL-7Efficacy-New Indication:
5/10/2022
Approval for OLUMIANT, 4MG
  • Reference Drug
  • Active Ingredient: BARICITINIB
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence:
5/10/2022SUPPL-6Efficacy-New Indication:
12/2/2021SUPPL-4Labeling-Medication Guide, Labeling-Package Insert:
7/8/2020SUPPL-2Labeling-Package Insert:
10/8/2019
Approval for OLUMIANT, 1MG
  • Reference Drug
  • Active Ingredient: BARICITINIB
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence:
10/8/2019SUPPL-1Efficacy-New Dosing Regimen:
5/31/2018
Approval for OLUMIANT, 2MG
  • Reference Drug
  • Active Ingredient: BARICITINIB
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence:
5/31/2018ORIG-1Approval: