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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 022560 Product 001 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N022560 001 5583122 Dec 10, 2013 Y Y U - 662
N022560 001 5583122*PED Jun 10, 2014
N022560 001 5622721 Apr 21, 2014 Y U - 662
N022560 001 7645459 Jan 9, 2028 Y U - 662
N022560 001 7645460 Jan 9, 2028 Y U - 662
N022560 001 8246989 Jan 16, 2026 Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N022560 001 NDF Oct 8, 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 November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014