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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 021356 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
N021356 001 5922695 Jul 25, 2017 Y U - 248
N021356 001 5922695 Jul 25, 2017 Y U - 256
N021356 001 5922695 Jul 25, 2017 Y U - 999
N021356 001 5922695 Jul 25, 2017 Y U - 250
N021356 001 5922695 Jul 25, 2017 Y U - 1275
N021356 001 5922695*PED Jan 25, 2018
N021356 001 5935946 Jul 25, 2017 Y Y U - 1275
N021356 001 5935946 Jul 25, 2017 Y Y U - 248
N021356 001 5935946 Jul 25, 2017 Y Y U - 256
N021356 001 5935946 Jul 25, 2017 Y Y U - 999
N021356 001 5935946 Jul 25, 2017 Y Y U - 250
N021356 001 5935946*PED Jan 25, 2018
N021356 001 5977089 Jul 25, 2017 Y Y U - 248
N021356 001 5977089 Jul 25, 2017 Y Y U - 256
N021356 001 5977089 Jul 25, 2017 Y Y U - 999
N021356 001 5977089 Jul 25, 2017 Y Y U - 250
N021356 001 5977089 Jul 25, 2017 Y Y U - 1275
N021356 001 5977089*PED Jan 25, 2018
N021356 001 6043230 Jul 25, 2017 U - 248
N021356 001 6043230 Jul 25, 2017 U - 256
N021356 001 6043230 Jul 25, 2017 U - 999
N021356 001 6043230 Jul 25, 2017 U - 250
N021356 001 6043230 Jul 25, 2017 U - 1275
N021356 001 6043230*PED Jan 25, 2018

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021356 001 M - 95 Oct 1, 2013
N021356 001 NPP Aug 16, 2015
N021356 001 NPP Jan 18, 2015
N021356 001 ODE Mar 24, 2017
N021356 001 PED Jul 18, 2015
N021356 001 PED Apr 1, 2014
N021356 001 PED Sep 24, 2013
N021356 001 PED Sep 24, 2017
N021356 001 M - 128 Jul 24, 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

Return to Electronic Orange Book Home Page


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 July 2014
Patent and Generic Drug Product Data Last Updated August 29, 2014

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