Viewing data from:

TUDORZA PRESSAIR

NDA

ACLIDINIUM BROMIDE | N202450 | AZURITY PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

Today

10085974

Mar. 13, 2029

11000517

Mar. 13, 2029

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

40 trials from ClinicalTrials.gov, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)NCT00358436	Phase 3	Completed	AstraZeneca	804	2006-08 → 2008-06
Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)NCT00891462	Phase 3	Completed	AstraZeneca	561	2009-04 → 2009-11
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)NCT00970268	Phase 3	Completed	AstraZeneca	291	2009-08 → 2010-10
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients NCT00435760	Phase 3	Completed	AstraZeneca	115	2007-02 → 2007-08
Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients NCT03022097	Phase 3	Completed	AstraZeneca	1,625	2017-02-02 → 2022-04-14
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)NCT01437397	Phase 3	Completed	AstraZeneca	1,692	2011-09 → 2013-02
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers NCT03104634	Phase 3	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	43	2017-05-01 → 2019-02-01
A Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)NCT02153489	Phase 4	Completed	AstraZeneca	30	2014-04 → 2015-06
Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT01908140	Phase 3	Completed	AstraZeneca	933	2013-09 → 2014-08
Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination NCT01462942	Phase 3	Completed	AstraZeneca	2,443	2011-10 → 2013-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 2 NDCs

Highest NADAC/Unit

$431.19

per ea

Lowest NADAC/Unit

$257.59

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70515000201TUDORZA PRESSAIR 400 MCG INHAL	$431.19	EA	Brand	—	2026-08-19
70515000202TUDORZA PRESSAIR 400 MCG INHAL	$257.59	EA	Brand	—	2026-08-19

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$185.13

Highest Price

$443.22

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70515-0002-01TUDORZA PRESSAIR 400MCG (60 DOSE)	$264.98	Big4	Covis Pharm S.a.r.l., Bertrange, Zug Branch	06/30/2026
70515-0002-01TUDORZA PRESSAIR 400MCG (60 DOSE)	$443.22	FSS	Covis Pharm S.a.r.l., Bertrange, Zug Branch	06/30/2026
70515-0002-02TUDORZA PRESSAIR 400MCG (30 DOSE)	$185.13	Big4	Covis Pharm S.a.r.l., Bertrange, Zug Branch	06/30/2026
70515-0002-02TUDORZA PRESSAIR 400MCG (30 DOSE)	$226.86	FSS	Covis Pharm S.a.r.l., Bertrange, Zug Branch	06/30/2026

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

Medicare Part D Spending

CMS annual spending data for Tudorza Pressair (2024)

Total Spending

$5.1M

Total Claims

7,487

Beneficiaries

1,936

Avg Cost/Unit

$383.18

Spending Trend

$34.9M(2019)→$25.6M(2020)→$18.0M(2021)→$14.4M(2022)→$10.6M(2023)→$5.1M(2024)

YoY Change:-29.2%

5yr CAGR:-8.6%

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

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDACLIDINIUM BROMIDE [ROUTE CODE "AU"]

DMF 280932014

INKE SAACLIDINIUM BROMIDE

DMF 364372023

HOVIONE FARMACIENCIA SAInactiveACLIDINIUM BROMIDE MICRONIZED

DMF 342312019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Apr 1, 2019	SUPPL -12	View Letter (PDF)
Nov 15, 2018	SUPPL -11	View Letter (PDF)
Mar 18, 2016	SUPPL -6	View Letter (PDF)
Apr 6, 2015	SUPPL -5	View Letter (PDF)
Nov 3, 2014	SUPPL -3	View Letter (PDF)
Jul 21, 2014	SUPPL -2	View Letter (PDF)
Jul 25, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4MG/INH

RLD

2 patents0 exclusivities▴

POWDER, METERED;INHALATION | Approved: Jul 23, 2012

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10085974	Mar 13, 2029	—	—	Yes		—
11000517	Mar 13, 2029	—	—	Yes		—