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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 021976 Product 005 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
N021976 005 5843946 Dec 1, 2015 Y U - 935
N021976 005 5843946 Dec 1, 2015 Y U - 1305
N021976 005 5843946 Dec 1, 2015 Y U - 1209
N021976 005 5843946 Dec 1, 2015 Y U - 744
N021976 005 5843946 Dec 1, 2015 Y U - 903
N021976 005 5843946*PED Jun 1, 2016
N021976 005 6037157 Jun 26, 2016 U - 935
N021976 005 6037157 Jun 26, 2016 U - 1305
N021976 005 6037157 Jun 26, 2016 U - 1209
N021976 005 6037157*PED Dec 26, 2016
N021976 005 6248775 Aug 13, 2014 Y
N021976 005 6248775*PED Feb 13, 2015
N021976 005 6703403 Jun 26, 2016 U - 935
N021976 005 6703403 Jun 26, 2016 U - 1305
N021976 005 6703403 Jun 26, 2016 U - 1209
N021976 005 6703403*PED Dec 26, 2016
N021976 005 7470506 Jun 23, 2019 U - 935
N021976 005 7470506 Jun 23, 2019 U - 1305
N021976 005 7470506 Jun 23, 2019 U - 1209
N021976 005 7470506*PED Dec 23, 2019
N021976 005 7700645 Dec 26, 2026 Y Y
N021976 005 7700645*PED Jun 26, 2027
N021976 005 8518987 Feb 16, 2024 Y Y
N021976 005 8518987*PED Aug 16, 2024
N021976 005 8597876 Jun 23, 2019 U - 1305
N021976 005 8597876*PED Dec 23, 2019
N021976 005 RE42889 Oct 19, 2016 Y
N021976 005 RE42889*PED Apr 19, 2017
N021976 005 RE43596 May 9, 2017 Y Y
N021976 005 RE43596*PED Nov 9, 2017
N021976 005 RE43802 Oct 19, 2016 U - 1305
N021976 005 RE43802*PED Apr 19, 2017

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021976 005 D - 129 Dec 13, 2013
N021976 005 D - 135 Feb 1, 2016
N021976 005 NPP Dec 16, 2014
N021976 005 PED Aug 1, 2016
N021976 005 PED Jun 16, 2015
N021976 005 PED Jun 13, 2014


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 September 2014
Patent and Generic Drug Product Data Last Updated October 30, 2014

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