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 021226 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
N021226 001 5541206 Jul 30, 2013 Y U - 348
N021226 001 5541206*PED Jan 30, 2014
N021226 001 5648497 Jul 15, 2014
N021226 001 5648497*PED Jan 15, 2015
N021226 001 5886036 Nov 19, 2013 Y Y
N021226 001 5886036*PED May 19, 2014
N021226 001 5914332 Dec 13, 2015 U - 351
N021226 001 5914332*PED Jun 13, 2016
N021226 001 5948436 Sep 13, 2013 Y
N021226 001 5948436*PED Mar 13, 2014
N021226 001 6037157 Jun 26, 2016 U - 346
N021226 001 6037157*PED Dec 26, 2016
N021226 001 6232333 Nov 7, 2017
N021226 001 6232333*PED May 7, 2018
N021226 001 6284767 Feb 15, 2016 Y U - 401
N021226 001 6284767 Feb 15, 2016 Y U - 688
N021226 001 6284767*PED Aug 15, 2016
N021226 001 6458818 Nov 7, 2017
N021226 001 6458818*PED May 7, 2018
N021226 001 6521651 Nov 7, 2017 Y
N021226 001 6521651*PED May 7, 2018
N021226 001 6703403 Jun 26, 2016 U - 257
N021226 001 6703403*PED Dec 26, 2016
N021226 001 7141593 May 22, 2020 Y
N021226 001 7141593*PED Nov 22, 2020
N021226 001 7432294 May 22, 2020 Y
N021226 001 7432294*PED Nov 22, 2020

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

Return to Electronic Orange Book Home Page

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 17, 2013
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