Viewing data from:

AIRSUPRA

NDA

ALBUTEROL SULFATE; BUDESONIDE | N214070 | ASTRAZENECA PHARMACEUTICALS LP

1 strength1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 2 exclusivities by expiration date

Active (1)TodayExclusivity

2026

2027

2028

2029

2030

Today

9415009

May. 28, 2030

Jan. 10, 2026

M-317

Sep. 15, 2028

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

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma NCT03847896	Phase 3	Completed	Bond Avillion 2 Development LP	1,001	2019-03-20 → 2021-07-20
A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma NCT04234464	Phase 3	Completed	Bond Avillion 2 Development LP	60	2020-01-15 → 2020-08-28
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma NCT03769090	Phase 3	Completed	Bond Avillion 2 Development LP	3,132	2018-12-13 → 2022-02-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$45.06

per gm

Lowest NADAC/Unit

$45.06

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00310908012AIRSUPRA 90-80 MCG INHALER	$45.06	GM	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$363.28

Highest Price

$484.43

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-9080-12AIRSUPRA 90MCG/80MCG/SPRAY INHL	$484.43	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-9080-12AIRSUPRA 90MCG/80MCG/SPRAY INHL	$363.28	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

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

Medicare Part D Spending

CMS annual spending data for Airsupra (2024)

Total Spending

$24.8M

Total Claims

46,082

Beneficiaries

25,835

Avg Cost/Unit

$43.56

Spending Trend

$925K(2023)→$24.8M(2024)

YoY Change:-7.5%

5yr CAGR:-7.5%

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 18, 2025	SUPPL -1	View Letter (PDF)
Jan 11, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09MG BASE/INH;0.08MG/INH

RLD

1 patent2 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Jan 10, 2023

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9415009	May 28, 2030	—	—	—		—

Exclusivities (2)

Code	Date	Status
M-317	Sep 15, 2028	Active
NP	Jan 10, 2026	Expired