STEGLUJAN

209805 | Orange Book

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Filed Dec. 19, 2017
Type New Drug Application
Case Type New Drug Application
Ingredients SITAGLIPTIN PHOSPHATE and ERTUGLIFLOZIN
Dosage Form / Route ORAL and TABLET
PatentExpiration
6,699,8712 years, 8 months ago
6,699,8712 years, 2 months ago
7,326,7081 year, 7 months from now
7,326,7082 years, 1 month from now
8,080,5805 years, 2 months from now
9,308,2045 years, 6 months from now
9,439,9015 years, 6 months from now
Last Updated: 2 years, 8 months ago
Date Patent / Filing No. Patent and Drug Application Information
10/21/20309439901Expiration of Patent No 9,439,901: (U-2214).
10/21/20309308204Expiration of Patent No 9,308,204: (drug product)
7/13/20308080580Expiration of Patent No 8,080,580: (U-2214). (drug product)
5/24/20277326708Expiration of Patent No 7,326,708: Has Pediatrict Exclusivity.
11/24/20267326708Expiration of Patent No 7,326,708: (U-2214). (drug product)
1/26/20236699871Expiration of Patent No 6,699,871: Has Pediatrict Exclusivity.
7/26/20226699871Expiration of Patent No 6,699,871: (U-2214). (drug product)
6/21/2022SUPPL-11Labeling-Package Insert:
3/2/2022SUPPL-10Labeling-Medication Guide:
9/17/2021SUPPL-8Efficacy-Labeling Change With Clinical Data:
1/24/2020SUPPL-6Labeling-Package Insert, Labeling-Medication Guide:
7/1/2019SUPPL-5Labeling-Package Insert:
10/26/2018SUPPL-4Labeling-Medication Guide, Labeling-Package Insert:
3/6/2018SUPPL-1Labeling-Package Insert:
12/19/2017
Approval for STEGLUJAN, 15MG;EQ 100MG BASE
  • Reference Drug
  • Active Ingredient: ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence:
12/19/2017
Approval for STEGLUJAN, 5MG;EQ 100MG BASE
  • Reference Drug
  • Active Ingredient: ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE
  • Dosage Form: TABLET
  • Dosage Route: ORAL
  • Therapeutic Equivalence:
12/19/2017ORIG-1Approval: