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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Patent and Exclusivity Search Results from query on Appl No 021937 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
N021937 001 5519021*PED Nov 21, 2013
N021937 001 5663169 Sep 2, 2014 U - 750
N021937 001 5663169 Sep 2, 2014 U - 1170
N021937 001 5663169*PED Mar 2, 2015
N021937 001 5814639 Sep 29, 2015 Y Y
N021937 001 5814639*PED Mar 29, 2016
N021937 001 5914331 Jul 2, 2017 Y
N021937 001 5914331*PED Jan 2, 2018
N021937 001 5922695 Jul 25, 2017 Y U - 750
N021937 001 5922695 Jul 25, 2017 Y U - 1170
N021937 001 5922695*PED Jan 25, 2018
N021937 001 5935946 Jul 25, 2017 Y Y U - 750
N021937 001 5935946 Jul 25, 2017 Y Y U - 1170
N021937 001 5935946*PED Jan 25, 2018
N021937 001 5977089 Jul 25, 2017 Y Y U - 750
N021937 001 5977089 Jul 25, 2017 Y Y U - 1170
N021937 001 5977089*PED Jan 25, 2018
N021937 001 6043230 Jul 25, 2017 U - 750
N021937 001 6043230 Jul 25, 2017 U - 1170
N021937 001 6043230*PED Jan 25, 2018
N021937 001 6639071 Feb 14, 2018 Y
N021937 001 6639071*PED Aug 14, 2018
N021937 001 6642245 Nov 4, 2020 U - 750
N021937 001 6642245 Nov 4, 2020 U - 1170
N021937 001 6642245*PED May 4, 2021
N021937 001 6703396 Mar 9, 2021 Y Y
N021937 001 6703396*PED Sep 9, 2021
N021937 001 6939964 Jan 20, 2018 Y
N021937 001 6939964*PED Jul 20, 2018
N021937 001 8592397 Jan 13, 2024 Y U - 750
N021937 001 8592397 Jan 13, 2024 Y U - 1170
N021937 001 8598185 May 1, 2028 Y
N021937 001 8716264 Jan 13, 2024 Y U - 257

Exclusivity Data

There is no unexpired exclusivity for this product.


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 August 2014
Patent and Generic Drug Product Data Last Updated September 17, 2014

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