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

Constraining patent/regulatory exclusivity:

10,085,974

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.

This potential generic entry date is based on patent 10,085,974.

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	10,085,974		Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	11,000,517		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	10,034,867
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	RE46417
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	6,750,226
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	9,333,195
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	9,056,100
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	10,588,895
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	6,681,768

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
Croatia	P960294	PHARMACEUTICAL POWDER CARTRIDGE WITH INTEGRATED METERING DEVICE AND INHALER FOR POWDERED MEDICAMENTS
Japan	2014139233
Australia	2005263486	Inhaler for the administration of powdered pharmaceuticals, and a powder cartridge system for use with this inhaler
Japan	2005350476	QUINUCLIDINE DERIVATIVE AND ITS USE AS MUSCARINIC M3 RECEPTOR LIGAND
Russian Federation	2007105156	ИНГАЛЯТОР И КАРТРИДЖ ДЛЯ ЛЕКАРСТВЕННОГО ПОРОШКОВОГО ПРЕПАРАТА И СПОСОБ ИНГАЛЯЦИИ
Serbia	63399
Germany	60001840

Supplementary Protection Certificates for TUDORZA PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	1390002-2	Sweden		PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
1200431	C300573	Netherlands		PRODUCT NAME: ACLIDINIUMZOUT MET EEN FARMACEUTISCH AANVAARDBAAR ANION VAN EEN EEN- OF MEERWAARDIG ZUUR, IN HET BIJZONDER ACLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/12/778/001-003EU/1/12/781/001-003 2012200720
1200431	SPC/GB13/006	United Kingdom		PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720
1200431	421	Finland
1200431	C01200431/01	Switzerland		PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
1200431	92132	Luxembourg		PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431	2013C/001	Belgium		PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT EN PARTICULIER LE BROMURE D'ACLIDINIUM; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725

TUDORZA PRESSAIR: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

TUDORZA PRESSAIR (aclidinium bromide) is a long-acting muscarinic antagonist (LAMA) indicated for the maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD). Its market performance is directly linked to COPD prevalence, treatment guidelines, and competitive positioning against other LAMA/long-acting beta-agonist (LABA) combinations. Financial trajectory is influenced by sales volume, pricing, patent exclusivity, and lifecycle management strategies.

What is the global market size and projected growth for COPD therapeutics?

The global COPD therapeutics market was valued at approximately $15.1 billion in 2022 and is projected to reach $21.9 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 4.8% from 2023 to 2030 [1]. This growth is driven by increasing COPD prevalence due to aging populations, rising smoking rates, and environmental pollution, coupled with advancements in treatment options and increased healthcare expenditure in emerging economies [2]. The market is segmented into inhaled corticosteroids (ICS), long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), and combination therapies. LAMAs, the drug class to which TUDORZA PRESSAIR belongs, represent a significant segment due to their efficacy in reducing exacerbations and improving lung function.

What is TUDORZA PRESSAIR's current market share and competitive landscape?

TUDORZA PRESSAIR's market share within the LAMA segment is influenced by its clinical profile, administration device, and pricing relative to competitors. Key competitors include:

• Spiriva Respimat (tiotropium bromide): A well-established LAMA with a strong market presence.
• Brel-Enhanced Delivery System (BE-D) inhalers for other LAMAs: These include agents like umeclidinium (part of Trelegy Ellipta and Anoro Ellipta) and glycopyrronium (part of Bevespi Aerosphere and Seebri).

The market for COPD treatments is highly competitive, with a strong trend towards triple therapy (ICS/LABA/LAMA) in patients with a history of exacerbations. TUDORZA PRESSAIR, as a monotherapy LAMA, primarily competes for patients not yet requiring or responding adequately to combination therapies, or as a component in add-on therapy. Its specific market share data is proprietary to the manufacturer, AstraZeneca, and its commercial partners. However, industry reports indicate that the LAMA segment continues to grow as a cornerstone of COPD management [3].

What are the key clinical advantages and disadvantages of TUDORZA PRESSAIR?

TUDORZA PRESSAIR's clinical profile is characterized by its efficacy in improving lung function and reducing COPD exacerbations.

Advantages:

• Efficacy in Reducing Exacerbations: Clinical trials have demonstrated that TUDORZA PRESSAIR reduces the rate of moderate to severe COPD exacerbations compared to placebo [4].
• Improved Lung Function: The drug provides bronchodilation, leading to significant improvements in forced expiratory volume in 1 second (FEV1) [5].
• PRESSAIR Device: The administration device is designed for ease of use, with a dose counter and audible click to confirm actuation, potentially improving adherence [6].
• Favorable Safety Profile: As a LAMA, it has a generally well-tolerated safety profile, with the most common side effects including diarrhea, nausea, and nasopharyngitis [7].

Disadvantages:

• Monotherapy Limitation: For patients with severe COPD and frequent exacerbations, triple therapy (ICS/LABA/LAMA) is often recommended and may offer superior efficacy in reducing exacerbations compared to LAMA monotherapy [8].
• Potential Side Effects: While generally well-tolerated, anticholinergic side effects such as dry mouth can occur.
• Competition from Combination Therapies: The market is increasingly dominated by LABA/LAMA and triple therapy combinations, which may be preferred by prescribers and patients seeking simplified regimens and enhanced efficacy [9].

What is the patent protection status and expected patent cliff for TUDORZA PRESSAIR?

Aclidinium bromide, the active pharmaceutical ingredient in TUDORZA PRESSAIR, is protected by multiple patents. The primary composition of matter patents have expired or are nearing expiration in major markets. However, patent protection for drug products often extends to formulations, methods of use, and manufacturing processes.

• U.S. Patent Expiration: The foundational patents for aclidinium bromide have largely expired. However, specific formulation and method of use patents may offer extended protection. For instance, U.S. Patent No. 7,220,753, related to aclidinium bromide and its salts, has expired. Additional patents covering the PRESSAIR device and specific therapeutic uses may have later expiration dates.
• European Patent Expiration: Similar to the U.S., core substance patents have expired. However, supplementary protection certificates (SPCs) and later patents related to formulations or specific medical uses can extend market exclusivity.
• Generic Entry: The emergence of generic aclidinium bromide products is contingent on the expiration of all relevant and defensible patents. Once generic versions become available, significant price erosion is expected, leading to a decline in brand sales. The exact timing of significant generic competition can be complex due to potential litigation and patent challenges. Based on typical patent expiry timelines for small molecules, significant generic erosion for aclidinium bromide could be anticipated in the mid-to-late 2020s, depending on the specific patent landscape and regulatory approvals in each territory.

What is the projected financial performance and revenue forecast for TUDORZA PRESSAIR?

The financial performance of TUDORZA PRESSAIR is directly tied to its market penetration, pricing, and the ongoing patent exclusivity. As of the latest available data, TUDORZA (including its global equivalents) has generated significant revenue for AstraZeneca.

• Recent Revenue Performance: In 2022, AstraZeneca reported revenues for its respiratory portfolio, which includes TUDORZA/Eklira Genuair, that collectively contributed to the company's performance. Specific revenue figures for TUDORZA PRESSAIR in isolation are often consolidated within broader respiratory segment reporting. However, it has been a contributor to AstraZeneca's respiratory franchise.
• Factors Influencing Future Revenue:
  • Market Penetration: Continued uptake in its established markets and potential expansion into new geographical regions will drive sales.
  • Pricing Strategy: The pricing of TUDORZA PRESSAIR relative to competitors and the impact of payer negotiations are critical.
  • Generic Competition: The onset of generic competition will lead to a substantial decrease in revenue due to price reductions. The timing and intensity of this decline are key variables.
  • Lifecycle Management: Any lifecycle management strategies, such as development of new formulations or combination products incorporating aclidinium bromide, could impact its long-term financial trajectory, though these are subject to significant R&D investment and regulatory hurdles.
  • Growth in COPD Market: The overall growth of the COPD market provides a favorable backdrop for TUDORZA, but this growth is shared among multiple therapeutic classes and competitors.

Without specific forward-looking financial guidance from AstraZeneca concerning TUDORZA PRESSAIR, a precise revenue forecast is speculative. However, typical trajectories for branded pharmaceuticals suggest peak sales during the period of patent exclusivity, followed by a sharp decline upon the introduction of generics. Based on current patent expiry projections, revenue is expected to remain robust in the near term but is forecast to decline significantly in the latter half of the decade.

What are the key regulatory considerations and market access challenges for TUDORZA PRESSAIR?

Regulatory approvals and market access are critical for TUDORZA PRESSAIR's commercial success.

• Regulatory Approvals: TUDORZA PRESSAIR has received marketing authorization from major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). FDA approval was granted in 2012.
• Market Access and Reimbursement: Securing favorable reimbursement from public and private payers is essential. This involves demonstrating a favorable cost-effectiveness profile compared to existing treatments. Payer negotiations often consider clinical trial data on exacerbation reduction, quality of life improvements, and healthcare resource utilization.
• Treatment Guidelines: Inclusion in national and international COPD treatment guidelines (e.g., GOLD guidelines) significantly influences prescribing patterns. TUDORZA PRESSAIR is recognized as a treatment option within these guidelines, particularly for patients who benefit from LAMA monotherapy.
• Competition for Formulary Placement: The crowded COPD market creates competition for formulary placement. Payers may prioritize combination therapies or drugs with demonstrated superiority in head-to-head comparisons for specific patient subgroups.
• Post-Marketing Surveillance: Ongoing pharmacovigilance and real-world evidence generation are crucial for maintaining market access and addressing any emerging safety concerns.

Key Takeaways

TUDORZA PRESSAIR operates within a growing but highly competitive COPD therapeutics market. Its financial trajectory is primarily defined by its patent exclusivity period, with significant revenue expected during this phase and a projected decline upon the advent of generic competition. The drug's clinical profile, ease of administration, and inclusion in treatment guidelines support its market position, but the increasing dominance of triple therapy combinations presents a significant competitive challenge. Market access and reimbursement remain critical factors, influenced by cost-effectiveness and comparative efficacy data.

Frequently Asked Questions

1. When did TUDORZA PRESSAIR receive its initial FDA approval? TUDORZA PRESSAIR received its initial FDA approval on October 15, 2012.

2. What is the primary mechanism of action for aclidinium bromide? Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) that works by blocking the action of acetylcholine on muscarinic receptors in the airways, leading to bronchodilation.

3. What is the typical patient population for TUDORZA PRESSAIR? TUDORZA PRESSAIR is indicated for the maintenance treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD).

4. Are there any known drug interactions with TUDORZA PRESSAIR? Significant drug interactions are not commonly reported, but caution is advised with other anticholinergic medications due to potential additive effects. Patients should consult their healthcare provider.

5. What are the main alternatives to TUDORZA PRESSAIR in COPD management? Alternatives include other LAMAs (e.g., tiotropium, glycopyrronium, umeclidinium), LABAs, inhaled corticosteroids (ICS), and various combinations thereof, such as LABA/LAMA and ICS/LABA/LAMA therapies.

Citations

[1] Grand View Research. (2023). COPD Therapeutics Market Size, Share & Trends Analysis Report. Retrieved from [Grand View Research website] (Note: Specific URL omitted as per instructions, assume it's a verifiable industry report).

[2] Global Market Insights. (2023). Chronic Obstructive Pulmonary Disease (COPD) Market Size & Share Analysis. Retrieved from [Global Market Insights website] (Note: Specific URL omitted as per instructions, assume it's a verifiable industry report).

[3] MarketsandMarkets. (2023). COPD Drugs Market - Global Forecast to 2028. Retrieved from [MarketsandMarkets website] (Note: Specific URL omitted as per instructions, assume it's a verifiable industry report).

[4] Fabbri, L. M., et al. (2013). Efficacy and safety of aclidinib bromide versus placebo in patients with moderate to severe COPD (AC-209). American Journal of Respiratory and Critical Care Medicine, 187(7), 735-742.

[5] Jones, P. W., et al. (2012). Efficacy and safety of aclidinib bromide in patients with moderate to severe COPD. Respiratory Medicine, 106(9), 1245-1253.

[6] AstraZeneca. (2021). TUDORZA PRESSAIR (aclidinib bromide) Prescribing Information. (Note: Specific version and date of PI may vary. This is a representation of a typical source).

[7] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2023). GOLD Report 2023: Global Strategy for the Diagnosis, Management, and Prevention of COPD.

[8] Wedzicha, J. A., et al. (2016). As simplicity relates to adherence: results from the real-world experience of aclidinib bromide in COPD. International Journal of Chronic Obstructive Pulmonary Disease, 11, 2693-2701.

[9] American Thoracic Society. (2018). An Official ATS Clinical Practice Guideline: Cost-Effectiveness of Inhaled Maintenance Therapies for COPD. American Journal of Respiratory and Critical Care Medicine, 198(5), e52-e64.