Orange Book

OZEMPIC

SEMAGLUTIDE · 4MG · TABLET · ORAL

NDA213051HUMAN PRESCRIPTION DRUGReference listed drug
Open FDA's page for this record
Approval date
20241209
Product number
005
Exclusivity
  1. Exclusivity code
    I-976
    Exclusivity expiration date
    20281017
Patents
  1. Patent number
    10278923
    Expiration date
    20340502
    Drug substance flag
    true
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250221
  2. Patent number
    11033499
    Expiration date
    20330619
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20260507
  3. Patent number
    11382957
    Expiration date
    20311216
    Drug substance flag
    true
    Drug product flag
    true
    Patent submission date
    20250221
  4. Patent number
    11833248
    Expiration date
    20390201
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250107
  5. Patent number
    12239739
    Expiration date
    20340502
    Drug substance flag
    true
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250506
  6. Patent number
    12396953
    Expiration date
    20390201
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250903
  7. Patent number
    12514822
    Expiration date
    20340502
    Patent use code
    U-2628
    Patent submission date
    20260114
  8. Patent number
    8129343
    Expiration date
    20311205
    Drug substance flag
    true
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250506
  9. Patent number
    8536122
    Expiration date
    20260320
    Drug substance flag
    true
    Drug product flag
    true
    Patent use code
    U-2628
    Patent submission date
    20250506
Products
  1. Brand name
    OZEMPIC
    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
      4MG
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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.