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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Patent and Exclusivity Search Results from query on Appl No 022567 Product 003 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N022567 003 5532241 Sep 29, 2019 Y Y
N022567 003 7834020 Jun 5, 2022 Y Y U - 839
N022567 003 8193195 Jun 5, 2022 U - 839
N022567 003 8236804 Jun 5, 2022 U - 839
N022567 003 8673921 Jun 5, 2022 Y Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022567 003 NCE Jan 21, 2016
N022567 003 D - 146 Mar 16, 2018

Additional information:

  1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
  2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be flagged with respect to other claims which may apply.

View a list of all patent use codes
View a list of all exclusivity codes

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 2016
Patent and Generic Drug Product Data Last Updated July 29, 2016