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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 022525 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
N022525 002 5061703 Apr 11, 2015 U - 539
N022525 002 5061703*PED Oct 11, 2015
N022525 002 8039009 Mar 24, 2029 U - 539
N022525 002 8039009*PED Sep 24, 2029
N022525 002 8168209 Nov 22, 2025 Y
N022525 002 8168209*PED May 22, 2026
N022525 002 8173708 Nov 22, 2025 U - 539
N022525 002 8173708*PED May 22, 2026
N022525 002 8283379 Nov 22, 2025 U - 539
N022525 002 8283379*PED May 22, 2026
N022525 002 8329752 Nov 22, 2025 Y
N022525 002 8329752*PED May 22, 2026
N022525 002 8362085 Nov 22, 2025 U - 539
N022525 002 8362085*PED May 22, 2026

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022525 002 M - 138 Jul 3, 2017
N022525 002 PED Jan 3, 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 August 2014
Patent and Generic Drug Product Data Last Updated October 01, 2014

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