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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 022037 Product 002 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
N022037 002 5854290 Sep 21, 2015 U - 494 Y
N022037 002 5854290*PED Mar 21, 2016
N022037 002 6287599 Dec 20, 2020 Y
N022037 002 6287599*PED Jun 20, 2021
N022037 002 6811794 Jul 4, 2022 Y U - 494
N022037 002 6811794*PED Jan 4, 2023

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022037 002 I - 635 Feb 25, 2014
N022037 002 D - 145 Nov 19, 2017
N022037 002 PED Aug 25, 2014
N022037 002 PED May 19, 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 November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014

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