Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 021906 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
N021906 002 5541206 Jul 30, 2013 Y Y U - 688
N021906 002 5541206*PED Jan 30, 2014
N021906 002 5648497 Jul 15, 2014 Y Y
N021906 002 5648497*PED Jan 15, 2015
N021906 002 5886036 Nov 19, 2013 Y Y U - 895
N021906 002 5886036*PED May 19, 2014
N021906 002 5914332 Dec 13, 2015 Y Y U - 688
N021906 002 5914332*PED Jun 13, 2016
N021906 002 6037157 Jun 26, 2016 U - 688
N021906 002 6037157*PED Dec 26, 2016
N021906 002 6284767 Feb 15, 2016 Y U - 688
N021906 002 6284767*PED Aug 15, 2016
N021906 002 6703403 Jun 26, 2016 U - 688
N021906 002 6703403*PED Dec 26, 2016
N021906 002 7148359 Jul 19, 2019 Y
N021906 002 7148359*PED Jan 19, 2020
N021906 002 7364752 Nov 10, 2020 Y U - 688
N021906 002 7364752*PED May 10, 2021
N021906 002 8025899 Dec 14, 2027 Y
N021906 002 8025899*PED Jun 14, 2028
N021906 002 8268349 Aug 25, 2024 Y
N021906 002 8268349*PED Feb 25, 2025
N021906 002 8309613 Dec 24, 2024 U - 688
N021906 002 8309613*PED Jun 24, 2025
N021906 002 8377952 Oct 22, 2027 U - 1372
N021906 002 8377952*PED Apr 22, 2028
N021906 002 8399015 Aug 25, 2024 Y
N021906 002 8399015*PED Feb 25, 2025

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021906 002 D - 124 Apr 27, 2013

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 April, 2013
    Patent and Generic Drug Product Data Last Updated: May 23, 2013
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