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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 021687 Product 004 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
N021687 004 5846966 Sep 21, 2013 Y U - 593
N021687 004 5846966 Sep 21, 2013 Y U - 473
N021687 004 5846966*PED Mar 21, 2014
N021687 004 RE37721 Oct 25, 2016 Y Y U - 473
N021687 004 RE37721*PED Apr 25, 2017
N021687 004 RE42461 Oct 25, 2016 Y Y U - 473
N021687 004 RE42461*PED Apr 25, 2017

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021687 004 M - 109 Jan 24, 2015


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 September 2014
Patent and Generic Drug Product Data Last Updated October 22, 2014

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