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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 021168 Product 002 in the OB_Rx list.

Patent Data

Appl No Prod No Patent No Patent
Drug Substance
Drug Product
Patent Use
N021168 002 6511678 Dec 18, 2018
N021168 002 6511678*PED Jun 18, 2019
N021168 002 6528090 Dec 18, 2018 Y
N021168 002 6528090*PED Jun 18, 2019
N021168 002 6713086 Dec 18, 2018 Y U - 579
N021168 002 6713086*PED Jun 18, 2019
N021168 002 6720004 Dec 18, 2018 Y
N021168 002 6720004*PED Jun 18, 2019

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 June 2016
Patent and Generic Drug Product Data Last Updated July 29, 2016