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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 003 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 003 5583122 Dec 10, 2013 Y Y U - 222
N020835 003 5583122 Dec 10, 2013 Y Y U - 756
N020835 003 5583122*PED Jun 10, 2014
N020835 003 5994329 Jul 17, 2018 U - 353
N020835 003 5994329*PED Jan 17, 2019
N020835 003 6015801 Jul 17, 2018 U - 353
N020835 003 6015801*PED Jan 17, 2019
N020835 003 6165513 Jun 10, 2018 Y
N020835 003 6165513*PED Dec 10, 2018
N020835 003 6432932 Jul 17, 2018 U - 595
N020835 003 6432932*PED Jan 17, 2019
N020835 003 6465443 Aug 14, 2018 Y
N020835 003 6465443*PED Feb 14, 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 October 2014
Patent and Generic Drug Product Data Last Updated November 26, 2014

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