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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 022037 Product 004 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N022037 004 5854290 Sep 21, 2015 U - 494 Y
N022037 004 5854290*PED Mar 21, 2016
N022037 004 6287599 Dec 20, 2020 Y
N022037 004 6287599*PED Jun 20, 2021
N022037 004 6811794 Jul 4, 2022 Y U - 494
N022037 004 6811794*PED Jan 4, 2023

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022037 004 D - 145 Nov 19, 2017
N022037 004 PED May 19, 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 February 2015
Patent and Generic Drug Product Data Last Updated March 31, 2015