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

2036

2037

2038

2039

2040

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Airduo Respiclick (2023)

Total Spending

$207K

Total Claims

467

Beneficiaries

254

Avg Cost/Unit

$402.11

Spending Trend

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

YoY Change:+10.1%

5yr CAGR:+6.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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