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: N021929

Product 002
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE (SYMBICORT) AEROSOL, METERED 0.16MG/INH;0.0045MG/INH

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7587988	04/10/2026		DP
002	7587988*PED	10/10/2026
002	8387615	03/26/2027		DP
002	8387615*PED	09/26/2027
002	8528545	10/16/2028		DP			10/09/2013
002	8528545*PED	04/16/2029
002	8616196	04/07/2029		DP			01/29/2014
002	8616196*PED	10/07/2029
002	8875699	11/10/2024		DP			12/12/2014
002	8875699*PED	05/10/2025

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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