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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 022181 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
N022181 001 7566462 Nov 16, 2025 Y
N022181 001 7566462*PED May 16, 2026
N022181 001 7566714 Nov 17, 2024 U - 989
N022181 001 7566714*PED May 17, 2025
N022181 001 7612073 Nov 17, 2024 U - 1010
N022181 001 7612073*PED May 17, 2025
N022181 001 7727987 Nov 17, 2024 Y
N022181 001 7727987*PED May 17, 2025
N022181 001 7947681 Nov 17, 2024 U - 1156 Y
N022181 001 7947681*PED May 17, 2025
N022181 001 8003126 Nov 16, 2025
N022181 001 8003126*PED May 17, 2015
N022181 001 8067416 Nov 17, 2024 U - 989
N022181 001 8067416*PED May 17, 2025
N022181 001 8318745 Nov 17, 2024 Y
N022181 001 8318745*PED May 17, 2025
N022181 001 RE43797 Nov 17, 2024 U - 1156
N022181 001 RE43797*PED May 17, 2025

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022181 001 ODE Dec 13, 2014
N022181 001 NPP Apr 23, 2017
N022181 001 PED Jun 13, 2015
N022181 001 PED Oct 23, 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 October 2014
Patent and Generic Drug Product Data Last Updated November 21, 2014

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