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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 201367 Product 001 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N201367 001 6740669 Nov 14, 2022 Y Y
N201367 001 6740669*PED May 14, 2023
N201367 001 7750028 Oct 19, 2018 U - 106
N201367 001 7750028*PED Apr 19, 2019

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N201367 001 ODE Nov 14, 2015
N201367 001 PED May 14, 2016

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 October 2015
Patent and Generic Drug Product Data Last Updated November 25, 2015