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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 022544 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
N022544 001 6340475 Sep 19, 2016 Y
N022544 001 6488962 Jun 20, 2020 Y
N022544 001 6635280 Sep 19, 2016 Y
N022544 001 6723340 Oct 25, 2021 Y
N022544 001 7438927 Feb 26, 2024 U - 1114
N022544 001 7731989 Oct 25, 2022 Y
N022544 001 8192756 Oct 25, 2022 Y U - 1114
N022544 001 8252332 Oct 25, 2022 Y U - 1114
N022544 001 8333992 Oct 25, 2022 Y U - 1114

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022544 001 NP Jan 28, 2014
N022544 001 ODE Jan 28, 2018


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 20, 2014

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