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: N208799

Product 006
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE (AIRDUO DIGIHALER) POWDER 0.232MG/INH;EQ 0.014MG BASE/INH

Patent Data

Product No	Patent No	Patent Expiration	Drug Substance	Drug Product	Patent Use Code	Delist Requested	Submission Date
006	8651103	03/26/2028		DP			08/02/2019
006	8651103*PED	09/26/2028
006	8714149	02/25/2032		DP			08/02/2019
006	8714149*PED	08/25/2032
006	8978966	01/13/2032		DP			08/02/2019
006	8978966*PED	07/13/2032
006	9066957	10/06/2034		DP	U-645		08/02/2019
006	9066957*PED	04/06/2035
006	9216260	06/28/2031		DP			08/02/2019
006	9216260*PED	12/28/2031
006	9463288	05/19/2025		DP			08/02/2019
006	9463288*PED	11/19/2025
006	9616024	09/01/2024		DP			08/02/2019
006	9616024*PED	03/01/2025
006	9731087	05/18/2031		DP			08/02/2019
006	9731087*PED	11/18/2031
006	9782550	08/28/2035		DP			08/02/2019
006	9782550*PED	02/28/2036
006	9782551	08/28/2035		DP			08/02/2019
006	9782551*PED	02/28/2036
006	9987229	09/01/2024		DP			08/02/2019
006	9987229*PED	03/01/2025
006	10022510	05/18/2031		DP			08/02/2019
006	10022510*PED	11/18/2031
006	10124131	05/18/2031		DP			08/02/2019
006	10124131*PED	11/18/2031
006	10195375	02/14/2031		DP			08/02/2019
006	10195375*PED	08/14/2031
006	10561808	01/01/2032		DP			03/19/2020
006	10561808*PED	07/01/2032
006	10569034	08/16/2036		DP			03/12/2020
006	10569034*PED	02/16/2037
006	10765820	05/19/2025		DP			10/06/2020
006	10765820*PED	11/19/2025
006	10918816	12/14/2035		DP			03/18/2021
006	10918816*PED	06/14/2036
006	11000653	12/18/2038		DP			06/10/2021
006	11000653*PED	06/18/2039
006	11173259	07/06/2040		DP			12/08/2021
006	11173259*PED	01/06/2041
006	11266796	02/22/2041		DP			04/07/2022
006	11266796*PED	08/22/2041
006	11344685	09/26/2039		DP			06/29/2022
006	11344685*PED	03/26/2040
006	11351317	02/10/2038		DP			06/29/2022
006	11351317*PED	08/10/2038
006	11357935	09/24/2038		DP			07/13/2022
006	11439777	05/24/2040		DP			10/06/2022
006	11464923	06/19/2040		DP			11/10/2022

Exclusivity Data

Product No	Exclusivity Code	Exclusivity Expiration

 

 

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