Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 021427 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
N021427 004 5023269*PED Dec 11, 2013
N021427 004 5508276 Jul 18, 2014 Y
N021427 004 5508276*PED Jan 18, 2015
N021427 004 6596756 Sep 10, 2019 U - 882
N021427 004 6596756*PED Mar 10, 2020

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021427 004 I - 632 Nov 4, 2013
N021427 004 M - 61 Oct 18, 2015
N021427 004 PED May 4, 2014
N021427 004 PED Apr 18, 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 March 01, 2014
Patent and Generic Drug Product Data Last Updated April 17, 2014

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