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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 021008 Product 001 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N021008 001 5639480*PED Dec 17, 2014
N021008 001 5688530 Nov 18, 2014 U - 268
N021008 001 5688530*PED May 18, 2015
N021008 001 5922338 Jul 13, 2016 Y
N021008 001 5922338*PED Jan 13, 2017
N021008 001 5922682 Jul 13, 2016 Y
N021008 001 5922682*PED Jan 13, 2017

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 February 2015
Patent and Generic Drug Product Data Last Updated April 01, 2015