Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Patent and Exclusivity Search Results from query on Appl No 020815 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
N020815	001	5393763	Jul 28, 2012			U - 114	Y
N020815	001	5457117	Jul 28, 2012			U - 114	Y
N020815	001	5478847	Mar 2, 2014			U - 114	Y
N020815	001	5811120	Mar 2, 2014
N020815	001	5972383	Mar 2, 2014			U - 287
N020815	001	6458811	Mar 10, 2017	Y	Y	U - 825
N020815	001	6797719	Mar 10, 2017		Y
N020815	001	6894064	Mar 10, 2017		Y	U - 657
N020815	001	6906086	Jul 28, 2012			U - 657
N020815	001	6906086	Jul 28, 2012			U - 662
N020815	001	RE38968	Jul 28, 2012			U - 657
N020815	001	RE38968	Jul 28, 2012			U - 662
N020815	001	RE39049	Jul 28, 2012			U - 657
N020815	001	RE39049	Jul 28, 2012			U - 662
N020815	001	RE39050	Mar 2, 2014			U - 657
N020815	001	RE39050	Mar 2, 2014			U - 662

 

Appl No	Prod No	Exclusivity Code	Exclusivity Expiration
N020815	001	ODE	Sep 13, 2014
N020815	001	I - 539	Sep 13, 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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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