Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Product Details

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: N207921

Product 002
BECLOMETHASONE DIPROPIONATE (QVAR REDIHALER) AEROSOL, METERED 0.08MG/INH

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
002	8132712	09/07/2028		DP			08/28/2017
002	8931476	07/17/2031		DP			08/28/2017
002	10022509	05/18/2031		DP			08/13/2018
002	10022510	05/18/2031		DP			08/13/2018
002	10086156	05/18/2031		DP			10/16/2018
002	10561808	01/01/2032		DP			03/19/2020
002	10695512	05/18/2031		DP			07/28/2020
002	10792447	01/25/2039		DP			10/29/2020
002	11395888	01/26/2038		DP			08/19/2022
002	11395889	05/18/2031		DP			08/19/2022
002	11559637	07/21/2039		DP			02/22/2023
002	11583643	08/19/2041		DP			03/20/2023
002	11793953	01/26/2038		DP			11/13/2023
002	11865247	01/26/2038		DP			01/23/2024
002	11896759	01/26/2038		DP			03/11/2024

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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