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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 022334 Product 001 in the OB_Rx list.


Patent Data

Appl No Prod No Patent No Patent
Expiration
Drug Substance
Claim
Drug Product
Claim
Patent Use
Code
Delist
Requested
N022334 001 5665772 Sep 9, 2019 Y Y
N022334 001 5665772*PED Mar 9, 2020
N022334 001 6004973 Jul 12, 2016 Y
N022334 001 6004973*PED Jan 12, 2017
N022334 001 7297703 Dec 6, 2019 Y
N022334 001 7297703*PED Jun 6, 2020
N022334 001 8410131 May 22, 2025 Y Y U - 1368
N022334 001 8410131*PED Nov 22, 2025
N022334 001 8436010 Feb 22, 2022 Y Y U - 1396
N022334 001 8436010*PED Aug 22, 2022

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022334 001 I - 630 Oct 29, 2013
N022334 001 I - 638 May 5, 2014
N022334 001 I - 650 Apr 26, 2015
N022334 001 I - 655 Jul 20, 2015
N022334 001 NCE Mar 30, 2014
N022334 001 ODE Apr 26, 2019
N022334 001 ODE May 5, 2018
N022334 001 ODE Oct 29, 2017
N022334 001 PED Apr 29, 2014
N022334 001 PED Sep 30, 2014
N022334 001 PED Nov 5, 2014
N022334 001 PED Oct 26, 2015
N022334 001 PED Apr 29, 2018
N022334 001 PED Nov 5, 2018
N022334 001 PED Oct 26, 2019


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 2014
Patent and Generic Drug Product Data Last Updated July 25, 2014

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