INLYTA

202324 | Orange Book

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Filed Jan. 27, 2012
Type New Drug Application
Case Type New Drug Application
Ingredients AXITINIB
Dosage Form / Route ORAL and TABLET
PatentExpiration
6,534,5243 months from now
6,534,5249 months, 1 week from now
8,791,1405 years, 10 months from now
8,791,1406 years, 4 months from now
10,570,20210 years from now
10,570,20210 years, 6 months from now
10,869,92411 years, 11 months from now
10,869,92412 years, 5 months from now
Last Updated: 1 day, 18 hours ago
Date Patent / Filing No. Patent and Drug Application Information
7/12/203710869924Expiration of Patent No 10,869,924: Has Pediatrict Exclusivity.
1/12/203710869924Expiration of Patent No 10,869,924: (U-3044).
8/3/203510570202Expiration of Patent No 10,570,202: Has Pediatrict Exclusivity.
2/3/203510570202Expiration of Patent No 10,570,202: (U-2844).
6/14/20318791140Expiration of Patent No 8,791,140: Has Pediatrict Exclusivity.
12/14/20308791140Expiration of Patent No 8,791,140:
10/29/20256534524Expiration of Patent No 6,534,524: Has Pediatrict Exclusivity.
4/29/20256534524Expiration of Patent No 6,534,524: (drug product)
7/16/2024SUPPL-16Labeling-Package Insert:
9/22/2022SUPPL-14Efficacy-Labeling Change With Clinical Data:
6/4/2020SUPPL-11Efficacy-New Indication:
1/23/2020SUPPL-10Labeling-Package Insert:
8/10/2018SUPPL-8Labeling-Package Insert:
6/16/2016SUPPL-5Manufacturing (CMC): Label is not available on this site.
    3/30/2016SUPPL-4Manufacturing (CMC): Label is not available on this site.
      12/29/2014SUPPL-3Labeling-Container/Carton Labels:
      8/1/2014SUPPL-2Labeling-Package Insert:
      9/16/2013SUPPL-1Labeling-Package Insert:
      1/27/2012
      Approval for INLYTA, 5MG
      • Reference Drug
      • Active Ingredient: AXITINIB
      • Dosage Form: TABLET
      • Dosage Route: ORAL
      • Therapeutic Equivalence:
      1/27/2012
      Approval for INLYTA, 1MG
      • Reference Drug
      • Active Ingredient: AXITINIB
      • Dosage Form: TABLET
      • Dosage Route: ORAL
      • Therapeutic Equivalence:
      1/27/2012ORIG-1Approval: