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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 021880 Product 003 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
N021880 003 5635517 Oct 4, 2019 Y U - 1211
N021880 003 6045501 Aug 28, 2018 U - 1210
N021880 003 6281230 Jul 24, 2016 U - 1212
N021880 003 6281230 Jul 24, 2016 U - 1414
N021880 003 6315720 Oct 23, 2020 U - 1210
N021880 003 6555554 Jul 24, 2016 Y U - 1211
N021880 003 6561976 Aug 28, 2018 U - 1210
N021880 003 6561977 Oct 23, 2020 U - 1210
N021880 003 6755784 Oct 23, 2020 U - 1210
N021880 003 6908432 Aug 28, 2018 U - 1210
N021880 003 7119106 Jul 24, 2016 Y
N021880 003 7189740 Apr 11, 2023 U - 1215
N021880 003 7465800 Apr 27, 2027 Y Y
N021880 003 7468363 Oct 7, 2023 U - 1414
N021880 003 7855217 Nov 24, 2024 Y Y
N021880 003 7968569 Oct 7, 2023 U - 1216
N021880 003 8204763 Aug 28, 2018 U - 1249
N021880 003 8288415 Jul 24, 2016 Y Y
N021880 003 8315886 Oct 23, 2020 U - 1249
N021880 003 8404717 Apr 11, 2023 U - 1215
N021880 003 8530498 May 15, 2023 U - 1216
N021880 003 8589188 Aug 28, 2018 U - 1210
N021880 003 8626531 Oct 23, 2020 U - 1210
N021880 003 8648095 May 15, 2023 U - 1216
N021880 003 8741929 Mar 8, 2028 U - 1414

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021880 003 I - 672 Jun 5, 2016
N021880 003 ODE Jun 5, 2020


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 21, 2014

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