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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 021588 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
N021588 002 5521184 Jan 4, 2015
N021588 002 5521184*PED Jul 4, 2015
N021588 002 6894051 May 23, 2019 Y Y U - 649
N021588 002 6894051*PED Nov 23, 2019
N021588 002 6958335 Dec 19, 2021 U - 791
N021588 002 6958335*PED Jun 19, 2022
N021588 002 7544799 Jan 16, 2019 Y Y Y
N021588 002 7544799*PED Jul 16, 2019
N021588 002 RE43932 Jan 16, 2019 Y Y
N021588 002 RE43932*PED Jul 16, 2019

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021588 002 I - 666 Jan 25, 2016
N021588 002 ODE Jan 25, 2020
N021588 002 ODE Dec 19, 2015


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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