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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 021688 Product 002 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N021688 002 6011068 Mar 8, 2018 Y Y
N021688 002 6031003 Dec 14, 2016
N021688 002 6211244 Oct 23, 2015 Y Y U - 560
N021688 002 6313146 Dec 14, 2016 Y Y
N021688 002 7829595 Sep 22, 2026 Y U - 1098
N021688 002 9375405 Sep 22, 2026 Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021688 002 ODE Feb 25, 2018
N021688 002 ODE Nov 21, 2021

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 June 2016
Patent and Generic Drug Product Data Last Updated July 26, 2016