TUDORZA PRESSAIR Drug Patent Profile

Which patents cover Tudorza Pressair, and when can generic versions of Tudorza Pressair launch?

Tudorza Pressair is a drug marketed by Covis and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-two patent family members in thirty-six countries.

The generic ingredient in TUDORZA PRESSAIR is aclidinium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aclidinium bromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Tudorza Pressair

Tudorza Pressair was eligible for patent challenges on July 23, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TUDORZA PRESSAIR

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	484
Drug Prices:	Drug price information for TUDORZA PRESSAIR
What excipients (inactive ingredients) are in TUDORZA PRESSAIR?	TUDORZA PRESSAIR excipients list
DailyMed Link:	TUDORZA PRESSAIR at DailyMed

See drug prices for TUDORZA PRESSAIR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TUDORZA PRESSAIR

NDA:

202450

Dosage:

POWDER, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TUDORZA PRESSAIR

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

US Patents and Regulatory Information for TUDORZA PRESSAIR

TUDORZA PRESSAIR is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes			Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes			Y

Expired US Patents for TUDORZA PRESSAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012

EU/EMA Drug Approvals for TUDORZA PRESSAIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Covis Pharma Europe B.V.	Bretaris Genuair	aclidinium bromide	EMEA/H/C/002706Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).	Authorised	no	no	no	2012-07-20
Covis Pharma Europe B.V.	Eklira Genuair	aclidinium bromide	EMEA/H/C/002211Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).	Authorised	no	no	no	2012-07-20

International Patents for TUDORZA PRESSAIR

When does loss-of-exclusivity occur for TUDORZA PRESSAIR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TUDORZA PRESSAIR around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	002534	CARTUCHO PARA UN POLVO FARMACEUTICO Y UN INHALADOR QUE LO COMPRENDE
China	1325129
Uruguay	26244	NUEVOS DERIVADOS DE QUINUCLIDINA Y COMPOSICIONES FARMACÉUTICAS QUE LOS CONTIENEN.

Supplementary Protection Certificates for TUDORZA PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	2013/002	Ireland		PRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 20120720
1200431	C01200431/01	Switzerland		PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
1200431	PA2013001,C1200431	Lithuania		PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720

Market Dynamics and Financial Trajectory for TUDORZA PRESSAIR (Aclidinium Bromide)

Last updated: July 28, 2025

Introduction

TUDORZA PRESSAIR (aclidinium bromide) is a long-acting muscarinic antagonist (LAMA) indicated primarily for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Since its approval by the FDA in 2012, it has established itself within a competitive respiratory therapeutics market, driven by demographic trends, regulatory pathways, and evolving treatment guidelines. This report delineates the prevailing market dynamics and projects the financial trajectory for TUDORZA PRESSAIR within the COPD segment, considering competitive factors, patent status, commercialization strategies, and healthcare policy impacts.

Market Context and Overview

COPD Market Landscape

COPD remains a leading cause of morbidity and mortality worldwide, with an estimated 251 million cases globally as of 2020, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD). The increasing aging population, tobacco consumption trends, and environmental factors drive rising COPD prevalence [1].

The global COPD therapeutics market is projected to reach USD 30 billion by 2027, with a compounded annual growth rate (CAGR) of approximately 4.2% from 2020 to 2027. The market segments include bronchodilators (LAMA, LABA), inhaled corticosteroids (ICS), and combination therapies. Among these, LAMAs like TUDORZA PRESSAIR hold a significant share owing to their efficacy in airflow limitation and symptom control.

Product Positioning

TUDORZA PRESSAIR functions as a once-daily inhalation therapy, offering convenience and adherence advantages over multiple-dose regimens. Its primary competitors include Spiriva (tiotropium), Seebri Neohaler (glycopyrrolate), and newer fixed-dose combinations. Despite patient and clinician preference for combination therapies, monotherapies like TUDORZA PRESSAIR retain sales through their targeted efficacy and regulatory approvals.

Market Dynamics Influencing TUDORZA PRESSAIR

Regulatory Environment and Patent Landscape

The patent protection landscape has historically influenced TUDORZA PRESSAIR’s market exclusivity. Originally granted patent protections extend into the early 2020s, with subsequent patent filings and formulations providing additional exclusivity measures. The expiration or potential patent challenges could impact future sales, prompting AstraZeneca and its partners to innovate or acquire new formulations or combination therapies.

Regulatory considerations also include the US and EU approval pathways, post-marketing surveillance, and adherence to evolving inhaler device standards. Any regulatory modifications, such as new inhaler techniques or device approvals, could influence market penetration.

Competitive Dynamics

The COPD market is highly competitive, with existing monotherapies and combination inhalers. Spiriva (tiotropium), marketed by Boehringer Ingelheim, remains the dominant LAMA, commanding approximately 40% of the market share in the US. The advent of combination therapies such as Fluticasone/Salmeterol (Advair) and LABA/LAMA fixed-dose combinations (e.g., Anoro Ellipta—vilanterol/umeclidinium) challenge monotherapy growth.

TUDORZA PRESSAIR’s differentiation factors include its inhaler device (Pressair), dosing convenience, and clinical efficacy. However, competition from generic versions of older formulations or alternative delivery devices may erode market share.

Pricing and Reimbursement Policies

Reimbursement landscapes significantly influence sales. Managed care organizations (MCOs) and national healthcare systems emphasize cost-effectiveness, with formularies favoring generics and branded innovations with demonstrated value.

TUDORZA PRESSAIR’s pricing strategy has been aligned with market standards, but ongoing negotiations with payers and formulary placements impact revenue. The shift toward value-based care models may incentivize the adoption of therapies with proven long-term benefits, potentially favoring combination therapies with expanded indications.

Demographic Trends and Prescriber Patterns

Aging populations in North America, Europe, and parts of Asia are increasing COPD prevalence. This demographic trend bolsters long-term demand for maintenance therapies like TUDORZA PRESSAIR.

Clinician prescribing behavior is also influenced by clinical guidelines (GOLD, NICE) which favor bronchodilator monotherapy or combination regimens based on disease severity. TUDORZA PRESSAIR’s role as a long-acting monotherapy remains relevant, especially for early to moderate disease cases.

Adherence and Patient Preferences

Inhaler device efficacy, ease of use, and adherence are critical for therapeutic outcomes. The Pressair device’s innovative dose counter and feedback mechanism improve adherence, positively impacting market acceptance. However, patient education initiatives are necessary to maximize utilization.

Financial Trajectory and Revenue Projections

Historical Sales Performance

Since its launch, TUDORZA PRESSAIR has experienced steady but moderate growth owing to its niche positioning and competitive pressures. In 2021, AstraZeneca reported global COPD revenues of approximately USD 10 billion, with TUDORZA PRESSAIR accounting for a noteworthy but diminishing fraction due to increasing competition.

Growth Drivers

• Pipeline and Formulation Expansion: Exploration of fixed-dose combinations incorporating TUDORZA PRESSAIR or its active component can expand market share. For instance, AZ’s development of combo inhalers like PT010 (triple therapy) indicates strategic pipeline investments.

• Geographic Expansion: Growth in emerging markets such as Asia-Pacific, Latin America, and Middle East offers significant revenue prospects driven by increasing COPD prevalence and expanding healthcare access.

• Regulatory Approvals: Achieving approvals for new indications or additional formulations can elevate sales. Recent filings for once-daily formulations in new territories are promising.

Challenges to Financial Growth

• Patent Expirations: Imminent patent cliffs in key regions like the US could facilitate generic erosion, drastically lowering prices and sales volumes. AstraZeneca’s proactive patent strategies or introduction of next-generation formulations aim to mitigate this impact.

• Market Saturation: In matured markets, the growth trajectory may plateau as the COPD patient pool stabilizes. The global trend towards combination therapy use could further limit monotherapy market share.

• Pricing Pressures: Payer-driven price reductions and cost-containment initiatives threaten profit margins.

Future Revenue Estimates

Based on market trends, clinical uptake, and pipeline developments, TUDORZA PRESSAIR’s annual global sales are projected to reach USD 500–700 million within five years, assuming successful pipeline execution and geographic expansion. This forecast assumes moderate market penetration of combination therapies and sustained demand aligned with demographic growth.

Strategic Recommendations

• Incorporate Combination Therapies: Pairing TUDORZA PRESSAIR with other agents can address the increasing preference for triple therapies, thus maintaining revenue momentum.

• Leverage Digital Engagement: Employ digital health tools to enhance inhaler adherence and patient engagement, translating into improved clinical outcomes and sales.

• Explore New Indications: Investigate off-label or newly approved indications such as asthma or bronchiectasis to diversify revenue streams.

• Pipeline Diversification: Invest in inhaler device innovation and next-generation formulations to extend patent protection and competitive edge.

Key Takeaways

• The COPD therapeutics market remains robust but highly competitive, with TUDORZA PRESSAIR positioned as a key monotherapy option owing to its efficacy, device innovation, and dosing convenience.

• Patent expiration timelines and increasing adoption of combination therapies present both risks and opportunities for revenue growth. Strategic pipeline investments and geographic expansion are vital.

• Market drivers include demographic aging, evolving clinical guidelines favoring combination treatments, and rising COPD prevalence globally, especially in emerging markets.

• Reimbursement and pricing strategies will significantly influence future financial performance, with payers leaning toward cost-effective, combination therapies with superior adherence profiles.

• AstraZeneca’s ongoing innovation, strategic alignments, and pipeline development are essential to sustain TUDORZA PRESSAIR’s market presence and financial trajectory.

FAQs

1. What is the primary clinical advantage of TUDORZA PRESSAIR over competitors?
   Its once-daily dosing, innovative inhaler device with feedback mechanisms, and established efficacy make it a convenient and reliable choice for COPD maintenance therapy.

2. How vulnerable is TUDORZA PRESSAIR to patent expirations?
   Patent protections are set to expire in the early 2020s in certain regions, making generic competition a significant threat. AstraZeneca mitigates this through formulation patents, pipeline innovation, and pipeline expansion.

3. What market segments are showing the most growth for TUDORZA PRESSAIR?
   Emerging markets and geographic regions with increasing COPD prevalence offer growth opportunities, especially as access to inhaler therapies improves.

4. Will combination therapies replace monotherapies in the COPD market?
   Increasing evidence and guidelines favor combination therapies for advanced disease, which could limit monotherapy sales like TUDORZA PRESSAIR unless integrated into combination regimens or repositioned.

5. What strategic moves can AstraZeneca undertake to enhance TUDORZA PRESSAIR’s market share?
   Developing fixed-dose combinations, expanding into new geographies, investing in inhaler device innovation, and exploring new indications will be critical.

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Sources:
[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD), 2020 Report.