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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 021852 Product 001 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N021852 001 5763426 Jun 9, 2015 Y Y
N021852 001 6753013 Jan 27, 2020 Y U - 193
N021852 001 6753013 Jan 27, 2020 Y U - 88
N021852 001 RE39706 Jun 9, 2015 Y Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021852 001 NPP Dec 23, 2017

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 October 2015
Patent and Generic Drug Product Data Last Updated December 01, 2015