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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 021908 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
N021908 001 5284858 Jul 14, 2014 Y
N021908 001 6414016 Sep 5, 2020 U - 717
N021908 001 6414016 Sep 5, 2020 U - 1392
N021908 001 6583174 Oct 16, 2020 Y
N021908 001 6982283 Dec 4, 2022 U - 1391
N021908 001 7064148 Aug 30, 2022 U - 739
N021908 001 7064148 Aug 30, 2022 U - 1404
N021908 001 7417067 Oct 16, 2020 Y
N021908 001 8026393 Oct 25, 2027 Y
N021908 001 8071613 Sep 5, 2020 U - 1203
N021908 001 8071613 Sep 5, 2020 U - 1393
N021908 001 8088934 May 18, 2021 Y
N021908 001 8097649 Oct 16, 2020 Y
N021908 001 8097653 Nov 14, 2022 U - 1214
N021908 001 8097653 Nov 14, 2022 U - 1394
N021908 001 8114890 Sep 5, 2020 Y
N021908 001 8338639 Jan 23, 2027 Y
N021908 001 8389542 Nov 14, 2022 Y U - 1345
N021908 001 8389542 Nov 14, 2022 Y U - 1395
N021908 001 8748481 Sep 1, 2025 U - 1520
N021908 001 8779187 Jul 23, 2027 Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021908 001 I - 670 Apr 19, 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 September 2014
Patent and Generic Drug Product Data Last Updated October 22, 2014

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