Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Patent and Exclusivity Search Results from query on Appl No 021588 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
N021588	002	5521184	Jan 4, 2015
N021588	002	5521184*PED	Jul 4, 2015
N021588	002	6894051	May 23, 2019	Y	Y	U - 649
N021588	002	6894051*PED	Nov 23, 2019
N021588	002	6958335	Dec 19, 2021			U - 791
N021588	002	6958335*PED	Jun 19, 2022
N021588	002	7544799	Jan 16, 2019	Y	Y
N021588	002	7544799*PED	Jul 16, 2019

 

Appl No	Prod No	Exclusivity Code	Exclusivity Expiration
N021588	002	ODE	Feb 1, 2009
N021588	002	PED	Nov 10, 2008
N021588	002	PED	Aug 1, 2009
N021588	002	I - 583	Dec 19, 2011
N021588	002	I - 512	Oct 19, 2009
N021588	002	ODE	Oct 19, 2013
N021588	002	I - 511	Oct 19, 2009
N021588	002	ODE	Oct 19, 2013
N021588	002	ODE	Oct 19, 2013
N021588	002	ODE	Oct 19, 2013
N021588	002	ODE	Oct 19, 2013
N021588	002	I - 513	Oct 19, 2009
N021588	002	I - 510	Oct 19, 2009
N021588	002	I - 514	Oct 19, 2009

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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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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