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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 022068 Product 001 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N022068 001 7169791 Jul 4, 2023 Y Y U - 836
N022068 001 8163904 Aug 23, 2028 Y Y
N022068 001 8293756 Sep 25, 2027 Y
N022068 001 8389537 Jul 18, 2026 Y Y U - 1374
N022068 001 8415363 Jul 18, 2026 Y Y U - 1407
N022068 001 8501760 Jul 18, 2026 Y Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022068 001 ODE Oct 29, 2014

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 February 2015
Patent and Generic Drug Product Data Last Updated March 27, 2015