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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 021360 Product 002 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N021360 002 5663169 Sep 2, 2014 U - 248
N021360 002 5663169*PED Mar 2, 2015
N021360 002 6639071 Feb 14, 2018 Y
N021360 002 6639071*PED Aug 14, 2018
N021360 002 6939964 Jan 20, 2018 Y
N021360 002 6939964*PED Jul 20, 2018

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021360 002 NPP May 2, 2016
N021360 002 PED Nov 2, 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 February 2015
Patent and Generic Drug Product Data Last Updated March 31, 2015