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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 022363 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
N022363 003 5753675 May 19, 2015 Y Y U - 998
N022363 003 5854259 Dec 29, 2015 Y
N022363 003 5856336 Dec 25, 2020 Y U - 998
N022363 003 6465477 Dec 20, 2016 Y
N022363 003 7022713 Feb 19, 2024 U - 998
N022363 003 8557993 Feb 2, 2024 Y Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022363 003 NCE Aug 3, 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

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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 July 2014
Patent and Generic Drug Product Data Last Updated August 27, 2014

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