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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 021153 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
N021153 002 5714504*PED Aug 3, 2015
N021153 002 5900424 May 4, 2016 Y U - 373
N021153 002 5900424 May 4, 2016 Y U - 729
N021153 002 5900424 May 4, 2016 Y U - 770
N021153 002 5900424*PED Nov 4, 2016
N021153 002 6147103 Oct 9, 2018
N021153 002 6147103*PED Apr 9, 2019
N021153 002 6166213 Oct 9, 2018
N021153 002 6166213*PED Apr 9, 2019
N021153 002 6191148 Oct 9, 2018
N021153 002 6191148*PED Apr 9, 2019
N021153 002 6369085 May 25, 2018 Y Y U - 729
N021153 002 6369085 May 25, 2018 Y Y U - 770
N021153 002 6369085*PED Nov 25, 2018
N021153 002 6428810 Nov 3, 2019 Y U - 469
N021153 002 6428810 Nov 3, 2019 Y U - 729
N021153 002 6428810 Nov 3, 2019 Y U - 770
N021153 002 6428810*PED May 3, 2020
N021153 002 7411070 May 25, 2018 Y
N021153 002 7411070*PED Nov 25, 2018
N021153 002 8466175 May 25, 2018 U - 1417
N021153 002 8466175*PED Nov 25, 2018

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 January 2016
Patent and Generic Drug Product Data Last Updated March 02, 2016

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