Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Patent and Exclusivity Search Results from query on Appl No 020699 Product 001 in the OB_Rx list.

Appl No	Prod No	Patent No	Patent Expiration	Drug Substance Claim	Drug Product Claim	Patent Use Code	Delist Requested
N020699	001	5916923	Jun 28, 2013			U - 398
N020699	001	5916923*PED	Dec 28, 2013			U - 398
N020699	001	6274171	Mar 20, 2017
N020699	001	6274171*PED	Sep 20, 2017
N020699	001	6310101	Jun 28, 2013			U - 46
N020699	001	6403120	Mar 20, 2017			U - 451
N020699	001	6403120	Mar 20, 2017			U - 535
N020699	001	6403120*PED	Sep 20, 2017			U - 451
N020699	001	6403120*PED	Sep 20, 2017			U - 535
N020699	001	6419958	Mar 20, 2017			U - 459
N020699	001	6419958	Mar 20, 2017			U - 535
N020699	001	6419958*PED	Sep 20, 2017			U - 459
N020699	001	6419958*PED	Sep 20, 2017			U - 535
N020699	001	6444708	Jun 28, 2013			U - 398
N020699	001	6444708*PED	Dec 28, 2013			U - 398

 

Appl No	Prod No	Exclusivity Code	Exclusivity Expiration
N020699	001	I - 537	Nov 18, 2008
N020699	001	I - 538	Nov 18, 2008
N020699	001	I - 561	Dec 14, 2010

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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