Orange Book product · Brand (NDA)

AIRDUO DIGIHALER

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Brand (NDA)NDA 208799DISCN TEVA PHARM

Jul 12, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 12, 2019
7 yr ago
Today
Patent 10195375 expires
Listed drug product patent expiration.
Feb 14, 2031
in 4 yr 9 mo
Patent 10195375*PED expires
Listed listed patent expiration.
Aug 14, 2031
in 5 yr 3 mo
Patent 9066957 expires
Listed drug product patent expiration.
Oct 06, 2034
in 8 yr 5 mo
Patent 9066957*PED expires
Listed listed patent expiration.
Apr 06, 2035
in 8 yr 11 mo
Patent 10918816 expires
Listed drug product patent expiration.
Dec 14, 2035
in 9 yr 8 mo
Patent 10918816*PED expires
Listed listed patent expiration.
Jun 14, 2036
in 10 yr 2 mo
Patent 11969544 expires
Listed drug product patent expiration.
Aug 20, 2039
in 13 yr 4 mo
Patent 11344685 expires
Listed drug product patent expiration.
Sep 26, 2039
in 13 yr 6 mo
Patent 11969544*PED expires
Listed listed patent expiration.
Feb 20, 2040
in 13 yr 10 mo
Patent 11344685*PED expires
Listed listed patent expiration.
Mar 26, 2040
in 14 yr
Patent 11173259 expires
Listed drug product patent expiration.
Jul 06, 2040
in 14 yr 3 mo
Patent 11173259*PED expires
Listed listed patent expiration.
Jan 06, 2041
in 14 yr 9 mo

Active ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Strength

0.113MG/INH;EQ 0.014MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 208799

Product number

005

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10195375	Feb 14, 2031	in 4 yr 9 mo	Product
10195375*PED	Aug 14, 2031	in 5 yr 3 mo
9066957	Oct 06, 2034	in 8 yr 5 mo	ProductU-645
9066957*PED	Apr 06, 2035	in 8 yr 11 mo
10918816	Dec 14, 2035	in 9 yr 8 mo	Product
10918816*PED	Jun 14, 2036	in 10 yr 2 mo
11969544	Aug 20, 2039	in 13 yr 4 mo	Product
11344685	Sep 26, 2039	in 13 yr 6 mo	Product
11969544*PED	Feb 20, 2040	in 13 yr 10 mo
11344685*PED	Mar 26, 2040	in 14 yr
11173259	Jul 06, 2040	in 14 yr 3 mo	Product
11173259*PED	Jan 06, 2041	in 14 yr 9 mo