Orange Book

WEGOVY

SEMAGLUTIDE · 9MG · TABLET · ORAL

NDA218316HUMAN PRESCRIPTION DRUGReference listed drug
Open FDA's page for this record
Approval date
20251222
Product number
003
Exclusivity
  1. Exclusivity code
    I-935
    Exclusivity expiration date
    20270308
  2. Exclusivity code
    NP
    Exclusivity expiration date
    20281222
Patents
  1. Patent number
    10278923
    Expiration date
    20340502
    Patent use code
    U-4389
    Patent submission date
    20260116
  2. Patent number
    11033499
    Expiration date
    20330619
    Drug product flag
    true
    Patent use code
    U-4496
    Patent submission date
    20260507
  3. Patent number
    11382957
    Expiration date
    20311216
    Drug product flag
    true
    Patent submission date
    20260116
  4. Patent number
    11833248
    Expiration date
    20390201
    Drug product flag
    true
    Patent use code
    U-4387
    Patent submission date
    20260116
  5. Patent number
    12239739
    Expiration date
    20340502
    Patent use code
    U-4388
    Patent submission date
    20260116
  6. Patent number
    12396953
    Expiration date
    20390201
    Drug product flag
    true
    Patent use code
    U-4387
    Patent submission date
    20260116
  7. Patent number
    8129343
    Expiration date
    20311205
    Drug substance flag
    true
    Drug product flag
    true
    Patent submission date
    20260204
  8. Patent number
    8536122
    Expiration date
    20260320
    Drug substance flag
    true
    Drug product flag
    true
    Patent submission date
    20260204
  9. Patent number
    9278123
    Expiration date
    20311216
    Drug product flag
    true
    Patent use code
    U-4389
    Patent submission date
    20260205
Products
  1. Brand name
    WEGOVY
    Application name
    NOVO
    Application type
    N
    Application number
    218316
    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
      9MG
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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.