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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 021366 Product 005 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
N021366 005 6316460 Aug 4, 2020 Y
N021366 005 6316460*PED Feb 4, 2021
N021366 005 6858618 Dec 17, 2021 U - 618
N021366 005 6858618*PED Jun 17, 2022
N021366 005 7030152 Apr 2, 2018 U - 1032
N021366 005 7030152*PED Oct 2, 2018
N021366 005 7964614 Apr 2, 2018 U - 1032
N021366 005 7964614*PED Oct 2, 2018
N021366 005 RE37314 Jan 8, 2016 Y
N021366 005 RE37314*PED Jul 8, 2016

Exclusivity Data

There is no unexpired exclusivity for this product.


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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