Orange Book

RYBELSUS

SEMAGLUTIDE · 7MG · TABLET · ORAL

NDA213051HUMAN PRESCRIPTION DRUGReference listed drug
Open FDA's page for this record
Approval date
20190920
Product number
002
Exclusivity
  1. Exclusivity code
    I-976
    Exclusivity expiration date
    20281017
Patents
  1. Patent number
    10086047
    Expiration date
    20311216
    Drug product flag
    true
    Patent submission date
    20191015
  2. Patent number
    10278923
    Expiration date
    20340502
    Patent use code
    U-2628
    Patent submission date
    20191015
  3. Patent number
    10933120
    Expiration date
    20330315
    Drug product flag
    true
    Patent submission date
    20210331
  4. Patent number
    10960052
    Expiration date
    20311216
    Drug product flag
    true
    Patent submission date
    20210426
  5. Patent number
    11033499
    Expiration date
    20330619
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20260507
  6. Patent number
    11382957
    Expiration date
    20311216
    Drug product flag
    true
    Patent submission date
    20220726
  7. Patent number
    11759501
    Expiration date
    20330315
    Drug product flag
    true
    Patent submission date
    20231012
  8. Patent number
    11759502
    Expiration date
    20330315
    Drug product flag
    true
    Patent submission date
    20231012
  9. Patent number
    11759503
    Expiration date
    20330315
    Drug product flag
    true
    Patent submission date
    20231012
  10. Patent number
    12239739
    Expiration date
    20340502
    Drug substance flag
    true
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250506
  11. Patent number
    12514822
    Expiration date
    20340502
    Patent use code
    U-2628
    Patent submission date
    20260114
  12. Patent number
    12594326
    Expiration date
    20330315
    Drug product flag
    true
    Patent submission date
    20260420
  13. +3 more not shown
Products
  1. Brand name
    RYBELSUS
    Application name
    NOVO
    Application type
    N
    Application number
    213051
    Reference listed drug
    true
    Reference standard
    true
    Marketing status
    HUMAN PRESCRIPTION DRUG
    Application full name
    NOVO NORDISK INC
    Dosage form
    TABLET
    Route
    ORAL
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      7MG
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.