Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Patent and Exclusivity Search Results from query on Appl No 020972 Product 001 in the OB_Rx list.

Appl No	Prod No	Patent No	Patent Expiration	Drug Substance Claim	Drug Product Claim	Patent Use Code
N020972	001	5519021	May 21, 2013	Y	Y
N020972	001	5519021*PED	Nov 21, 2013
N020972	001	5663169	Sep 2, 2014			U - 257
N020972	001	5663169*PED	Mar 2, 2015
N020972	001	5811423	Aug 7, 2012	Y	Y	U - 256
N020972	001	6238695	Apr 6, 2019		Y
N020972	001	6238695*PED	Oct 6, 2019
N020972	001	6555133	Apr 6, 2019			U - 248
N020972	001	6555133*PED	Oct 6, 2019
N020972	001	6639071	Feb 14, 2018	Y
N020972	001	6639071*PED	Aug 14, 2018
N020972	001	6939964	Jan 20, 2018	Y
N020972	001	6939964*PED	Jul 20, 2018

There is no unexpired exclusivity for this product.

Additional information:

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).
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.

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 22, 2013