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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 022554 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
N022554 001 6861053 Aug 11, 2019 U - 1707
N022554 001 6861053 Aug 11, 2019 U - 1708
N022554 001 7045620 Jun 19, 2024 Y
N022554 001 7452857 Aug 11, 2019 U - 1707
N022554 001 7452857 Aug 11, 2019 U - 1708
N022554 001 7605240 Aug 11, 2019 U - 1708
N022554 001 7605240 Aug 11, 2019 U - 1707
N022554 001 7612199 Jun 19, 2024 Y Y
N022554 001 7718608 Aug 11, 2019 U - 1708
N022554 001 7718608 Aug 11, 2019 U - 1707
N022554 001 7902206 Jun 19, 2024 Y Y
N022554 001 7906542 Jun 1, 2025 Y Y
N022554 001 7915275 Feb 23, 2025 U - 1707
N022554 001 7915275 Feb 23, 2025 U - 1708
N022554 001 7935799 Aug 11, 2019 U - 1708
N022554 001 7935799 Aug 11, 2019 U - 1707
N022554 001 8158644 Jun 19, 2024 Y
N022554 001 8158781 Jun 19, 2024 Y
N022554 001 8193196 Sep 2, 2027 Y Y U - 1708
N022554 001 8193196 Sep 2, 2027 Y Y U - 1707
N022554 001 8309569 Jul 18, 2029 U - 1708
N022554 001 8309569 Jul 18, 2029 U - 1707
N022554 001 8518949 Feb 27, 2026 Y
N022554 001 8642573 Oct 2, 2029 U - 1481
N022554 001 8741904 Feb 27, 2026 Y U - 1708
N022554 001 8741904 Feb 27, 2026 Y U - 1707
N022554 001 8741904 Feb 27, 2026 Y U - 1526
N022554 001 8829017 Jul 24, 2029 U - 1562
N022554 001 8835452 Jun 19, 2024 Y Y
N022554 001 8853231 Jun 19, 2024 Y
N022554 001 8946252 Jul 24, 2029 U - 1481
N022554 001 8969398 Oct 2, 2029 U - 1481

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022554 001 I - 709 May 27, 2018
N022554 001 ODE Mar 24, 2017


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 June 2015
Patent and Generic Drug Product Data Last Updated July 31, 2015

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