Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

• Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
• Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
• As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N022519

Product 001
FAMOTIDINE; IBUPROFEN (DUEXIS) TABLET 26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8067451	07/18/2026		DP	U-1196		11/30/2011
001	8309127	07/18/2026		DP			11/13/2012
001	8318202	07/18/2026		DP			11/27/2012
001	8449910	07/18/2026		DP			05/28/2013
001	8501228	07/18/2026			U-1196		08/06/2013

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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