Viewing data from:

AIRDUO RESPICLICK

NDA

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | N208799 | TEVA PHARMACEUTICAL INDUSTRIES LTD

6 strengths7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)TodayPED (+6 mo)

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

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2039

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2041

Today

Apr. 6, 2035

Apr. 6, 2035

Aug. 14, 2031

Jun. 14, 2036

Jan. 6, 2041

Mar. 26, 2040

Feb. 20, 2040

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

88 trials from ClinicalTrials.gov, 81 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets NCT00328718	Phase 3	Completed	GlaxoSmithKline	526	2005-10 → 2007-04
A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT01706328	Phase 3	Completed	GlaxoSmithKline	828	2012-10-15 → 2013-06-17
Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg NCT01762800	Phase 4	Completed	GlaxoSmithKline	407	2013-02 → 2015-09
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler NCT02980133	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	841	2016-12-28 → 2019-04-13
Study Of Asthma In Patients Of African Descent NCT00102765	Phase 4	Completed	GlaxoSmithKline	479	2004-11 → 2007-04
Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations NCT00115492	Phase 4	Completed	GlaxoSmithKline	797	2004-12 → 2007-06
Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.NCT00169546	Phase 4	Completed	GlaxoSmithKline	64	2003-01 → 2005-12
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT00268216	Phase 3	Completed	GlaxoSmithKline	6,228	2000-09 → 2005-11
Study Of Allergic Rhinitis In Patients Who Also Have Asthma NCT00296491	Phase 4	Completed	GlaxoSmithKline	725	2005-09 → 2007-10
Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)NCT00424008	Phase 3	Completed	Organon and Co	722	2007-04 → 2008-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$113.81

per ea

Lowest NADAC/Unit

$103.38

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093360882FLUTICASONE-SALMETEROL 113-14	$113.81	EA	Generic	—	2026-06-17
00093360782FLUTICASONE-SALMETEROL 55-14	$111.44	EA	Generic	—	2026-06-17
00093360982FLUTICASONE-SALMETEROL 232-14	$103.38	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$61.80

Highest Price

$362.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-3607-82FLUTICASONE 55MCG/SALMETEROL 14MCG INHL,ORAL	$85.98	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3607-82FLUTICASONE 55MCG/SALMETEROL 14MCG INHL,ORAL	$61.80	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3608-82FLUTICASONE 113MCG/SALMETEROL 14MCG INHL,ORAL	$85.98	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3608-82FLUTICASONE 113MCG/SALMETEROL 14MCG INHL,ORAL	$66.55	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3609-82FLUTICASONE 232MCG/SALMETEROL 14MCG INHL,ORAL	$85.98	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3609-82FLUTICASONE 232MCG/SALMETEROL 14MCG INHL,ORAL	$64.10	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Airduo Respiclick (2024)

Total Spending

$257K

Total Claims

593

Beneficiaries

346

Avg Cost/Unit

$362.27

Spending Trend

$270K(2019)→$256K(2020)→$256K(2021)→$272K(2022)→$207K(2023)→$257K(2024)

YoY Change:-9.9%

5yr CAGR:+3.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 17, 2023	SUPPL -26	View Letter (PDF)
Mar 10, 2022	SUPPL -19	View Letter (PDF)
Jul 13, 2021	SUPPL -21	View Letter (PDF)
Feb 25, 2020	SUPPL -11	View Letter (PDF)
Mar 12, 2018	SUPPL -1	View Letter (PDF)
Dec 27, 2017	SUPPL -2	View Letter (PDF)
Jan 31, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#004 — 0.055MG/INH;EQ 0.014MG BASE/INH

RLD

7 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jul 12, 2019

#005 — 0.113MG/INH;EQ 0.014MG BASE/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jul 12, 2019

#006 — 0.232MG/INH;EQ 0.014MG BASE/INH

RLD

6 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jul 12, 2019

#001 — 0.055MG/INH;EQ 0.014MG BASE/INH

RLD

4 patents0 exclusivities▴

POWDER;INHALATION | Approved: Jan 27, 2017

Patents (4) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9066957	Oct 6, 2034PED: Apr 6, 2035	PED	—	Yes		—
9415008	Oct 6, 2034PED: Apr 6, 2035	PED	—	Yes		—
10195375	Feb 14, 2031PED: Aug 14, 2031	PED	—	Yes	—	—
11969544	Aug 20, 2039PED: Feb 20, 2040	PED	—	Yes	—	—

#002 — 0.113MG/INH;EQ 0.014MG BASE/INH

RLD

3 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jan 27, 2017

#003 — 0.232MG/INH;EQ 0.014MG BASE/INH

RLD

3 patents0 exclusivities▾

POWDER;INHALATION | Approved: Jan 27, 2017