Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Patent and Exclusivity Search Results from query on Appl No 021071 Product 002 in the OB_Rx list.

Appl No	Prod No	Patent No	Patent Expiration	Drug Substance Claim	Drug Product Claim	Patent Use Code	Delist Requested
N021071	002	5002953	Sep 17, 2011	Y	Y	U - 329
N021071	002	5002953	Sep 17, 2011	Y	Y	U - 628
N021071	002	5002953	Sep 17, 2011	Y	Y	U - 840
N021071	002	5002953*PED	Mar 17, 2012
N021071	002	5741803	Apr 21, 2015	Y	Y	U - 329	Y
N021071	002	5741803	Apr 21, 2015	Y	Y	U - 628	Y
N021071	002	5741803*PED	Oct 21, 2015
N021071	002	6288095	Feb 11, 2017			U - 420	Y
N021071	002	6288095*PED	Aug 11, 2017
N021071	002	7358366	Apr 19, 2020	Y
N021071	002	7358366*PED	Oct 19, 2020

 

There is no unexpired exclusivity for this product.

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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.

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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 December, 2009

Patent and Generic Drug Product Data Last Updated: February 04, 2010