XYREM

021196 | Orange Book

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Filed July 17, 2002
Type New Drug Application
Case Type New Drug Application
Ingredients SODIUM OXYBATE
Dosage Form / Route ORAL and SOLUTION
PatentExpiration
10,213,4007 years, 11 months from now
10,864,1817 years, 11 months from now
11,253,4947 years, 11 months from now
11,986,4467 years, 11 months from now
8,772,3067 years, 11 months from now
9,050,3027 years, 11 months from now
9,486,4267 years, 11 months from now
10,213,4008 years, 5 months from now
10,864,1818 years, 5 months from now
11,253,4948 years, 5 months from now
8,772,3068 years, 5 months from now
9,050,3028 years, 5 months from now
9,486,4268 years, 5 months from now
Last Updated: 14 hours ago
Date Patent / Filing No. Patent and Drug Application Information
9/15/20339486426Expiration of Patent No 9,486,426: Has Pediatrict Exclusivity.
9/15/20339050302Expiration of Patent No 9,050,302: Has Pediatrict Exclusivity.
9/15/20338772306Expiration of Patent No 8,772,306: Has Pediatrict Exclusivity.
9/15/203311253494Expiration of Patent No 11,253,494: Has Pediatrict Exclusivity.
9/15/203310864181Expiration of Patent No 10,864,181: Has Pediatrict Exclusivity.
9/15/203310213400Expiration of Patent No 10,213,400: Has Pediatrict Exclusivity.
3/15/20339486426Expiration of Patent No 9,486,426: (U-1532).
3/15/20339050302Expiration of Patent No 9,050,302: (U-1532).
3/15/20338772306Expiration of Patent No 8,772,306: (U-1532).
3/15/203311986446Expiration of Patent No 11,986,446: (U-3324).
3/15/203311253494Expiration of Patent No 11,253,494: (U-3323).
3/15/203310864181Expiration of Patent No 10,864,181: (U-1532).
3/15/203310213400Expiration of Patent No 10,213,400: (U-2499).
11/18/2024SUPPL-46REMS - MODIFIED - D-N-A: Label is not available on this site.
5/22/2024SUPPL-44REMS - MODIFIED - D-N-A: Label is not available on this site.
1/16/2024SUPPL-43REMS - MODIFIED - D-N-A: Label is not available on this site.
4/4/2023SUPPL-42Labeling-Package Insert:
8/22/2022SUPPL-40Labeling-Package Insert:
2/9/2022SUPPL-39REMS - MODIFIED - D-N-A: Label is not available on this site.
12/9/2021SUPPL-38REMS - MODIFIED - D-N-A: Label is not available on this site.
8/12/2021SUPPL-36REMS - MODIFIED - D-N-A: Label is not available on this site.
2/11/2021SUPPL-35REMS - MODIFIED - D-N-A: Label is not available on this site.
9/25/2020SUPPL-32Efficacy-Labeling Change With Clinical Data:
7/21/2020SUPPL-34REMS - MODIFIED - D-N-A:
7/21/2020SUPPL-33Labeling-Package Insert:
5/9/2019SUPPL-31Labeling-Container/Carton Labels:
10/26/2018SUPPL-30Efficacy-New Patient Population:
11/16/2017SUPPL-28Labeling-Package Insert:
4/19/2017SUPPL-26Labeling-Package Insert:
1/26/2017SUPPL-27Labeling-Package Insert:
6/23/2016SUPPL-25Manufacturing (CMC): Label is not available on this site.
    8/17/2015SUPPL-22Manufacturing (CMC): Label is not available on this site.
      7/15/2015SUPPL-23Labeling-Package Insert:
      2/27/2015SUPPL-15Labeling, REMS-Proposal: Label is not available on this site.
      2/23/2015SUPPL-20Manufacturing (CMC): Label is not available on this site.
        4/11/2014SUPPL-19Efficacy-Labeling Change With Clinical Data:
        12/20/2013SUPPL-18Manufacturing (CMC): Label is not available on this site.
          12/17/2012SUPPL-13Labeling:
          11/13/2006SUPPL-12Labeling: Label is not available on this site.
          6/30/2006SUPPL-9Labeling: Label is not available on this site.
          11/18/2005SUPPL-5Efficacy-New Indication:
          9/16/2005SUPPL-7Labeling: Label is not available on this site.
          11/4/2003SUPPL-1Labeling: Label is not available on this site.
          7/17/2002
          Approval for XYREM, 0.5GM/ML
          • Reference Drug
          • Active Ingredient: SODIUM OXYBATE
          • Dosage Form: SOLUTION
          • Dosage Route: ORAL
          • Therapeutic Equivalence:
          7/17/2002ORIG-1Approval: