Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 020835 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
N020835 001 5583122 Dec 10, 2013 U - 222
N020835 001 5583122*PED Jun 10, 2014
N020835 001 6165513 Jun 10, 2018
N020835 001 6165513*PED Dec 10, 2018

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N020835 001 PED Jan 23, 2013
N020835 001 M - 61 Jul 23, 2012

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 April, 2013
    Patent and Generic Drug Product Data Last Updated: May 17, 2013
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