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: N204275

Product 002
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE (BREO ELLIPTA) POWDER 0.2MG/INH;EQ 0.025MG BASE/INH

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	7439393	05/21/2025	DS	DP	U-1691 U-2099 U-2100 U-3623		05/07/2015
002	7439393*PED	11/21/2025
002	8161968	02/05/2028		DP			05/07/2015
002	8161968*PED	08/05/2028
002	8511304	06/14/2027		DP	U-1691 U-3623		05/07/2015
002	8511304*PED	12/14/2027
002	8534281	03/08/2030		DP			05/07/2015
002	8534281*PED	09/08/2030
002	8746242	10/11/2030		DP			05/07/2015
002	8746242*PED	04/11/2031
002	9333310	10/02/2027		DP			05/20/2016
002	9333310*PED	04/02/2028
002	11116721	02/26/2029		DP	U-1691 U-3623		10/12/2021
002	11116721*PED	08/26/2029

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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