Orange Book product · Brand (NDA)

AIRDUO RESPICLICK

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Brand (NDA)NDA 208799RX TEVA PHARM

Jan 27, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 27, 2017
9 yr 6 mo 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 11969544 expires
Listed drug product patent expiration.
Aug 20, 2039
in 13 yr 4 mo
Patent 11969544*PED expires
Listed listed patent expiration.
Feb 20, 2040
in 13 yr 10 mo

Active ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Strength

0.232MG/INH;EQ 0.014MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Not listed

Application

NDA 208799

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
11969544	Aug 20, 2039	in 13 yr 4 mo	Product
11969544*PED	Feb 20, 2040	in 13 yr 10 mo