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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 021344 Product 001 in the OB_Rx list.


Patent Data

Appl No Prod No Patent No Patent
Expiration
Drug Substance
Claim
Drug Product
Claim
Patent Use
Code
Delist
Requested
N021344 001 6774122 Jan 9, 2021 U - 596
N021344 001 6774122*PED Jul 9, 2021
N021344 001 7456160 Jan 9, 2021 U - 596
N021344 001 7456160*PED Jul 9, 2021
N021344 001 8329680 Jan 9, 2021 U - 596
N021344 001 8329680*PED Jul 9, 2021
N021344 001 8466139 Jan 9, 2021 U - 596
N021344 001 8466139*PED Jul 9, 2021

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021344 001 D - 126 Sep 9, 2013
N021344 001 M - 103 May 17, 2014
N021344 001 M - 123 Nov 9, 2015
N021344 001 PED Nov 17, 2014
N021344 001 PED Mar 9, 2014


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

Return to Electronic Orange Book Home Page


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 2014
Patent and Generic Drug Product Data Last Updated November 26, 2014

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