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: N203634

Product 001
BUDESONIDE (UCERIS) TABLET, EXTENDED RELEASE 9MG

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
001	8895064	09/07/2031		DP			11/25/2014
001	9132093	09/07/2031		DP			09/16/2015
001	9192581	09/07/2031		DP	U-1325		12/03/2015
001	10307375	09/07/2031		DP			06/14/2019
001	10660858	09/07/2031		DP			07/21/2020

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

View a list of all patent use codes
View a list of all exclusivity codes