Orange Book

WEGOVY

SEMAGLUTIDE · 1MG/0.5ML (1MG/0.5ML) · SOLUTION · SUBCUTANEOUS

NDA215256HUMAN PRESCRIPTION DRUGReference listed drug
Open FDA's page for this record
Approval date
20210604
Product number
003
Exclusivity
  1. Exclusivity code
    I-935
    Exclusivity expiration date
    20270308
  2. Exclusivity code
    I-973
    Exclusivity expiration date
    20280815
Patents
  1. Patent number
    10888605
    Expiration date
    20380824
    Drug product flag
    true
    Patent use code
    U-3162
    Patent submission date
    20210630
  2. Patent number
    11318191
    Expiration date
    20410217
    Drug product flag
    true
    Patent use code
    U-3162
    Patent submission date
    20220629
  3. Patent number
    11478533
    Expiration date
    20400513
    Patent use code
    U-3861
    Patent submission date
    20250903
  4. Patent number
    11752198
    Expiration date
    20380824
    Drug product flag
    true
    Patent use code
    U-3162
    Patent submission date
    20231010
  5. Patent number
    12214017
    Expiration date
    20380824
    Drug product flag
    true
    Patent use code
    U-3162
    Patent submission date
    20250306
  6. Patent number
    8129343
    Expiration date
    20311205
    Drug substance flag
    true
    Drug product flag
    true
    Patent submission date
    20210630
  7. Patent number
    8536122
    Expiration date
    20260320
    Drug substance flag
    true
    Drug product flag
    true
    Patent submission date
    20210630
  8. Patent number
    9764003
    Expiration date
    20330621
    Patent use code
    U-3161
    Patent submission date
    20210630
Products
  1. Brand name
    WEGOVY
    Application name
    NOVO
    Application type
    N
    Application number
    215256
    Reference listed drug
    true
    Reference standard
    true
    Marketing status
    HUMAN PRESCRIPTION DRUG
    Application full name
    NOVO NORDISK INC
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1MG/0.5ML (1MG/0.5ML)
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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.