Last updated: September 2, 2026
Aclidinium bromide/formoterol fumarate is a twice-daily long-acting muscarinic antagonist/long-acting beta2-agonist combination for maintenance treatment of chronic obstructive pulmonary disease. It is marketed as Duaklir Pressair in the United States and as Duaklir Genuair or equivalent regional brands in some international markets. The product has limited commercial scale relative to once-daily LAMA/LABA combinations and triple therapies.
Its financial profile is constrained by five factors: intense COPD competition, twice-daily dosing, limited differentiation from established LAMA/LABA products, regional licensing fragmentation and the absence of separately reported revenue. Patent and device protection can delay direct substitution, but the product does not have biologic-style exclusivity barriers.
What is aclidinium bromide/formoterol fumarate and how does it work?
Aclidinium bromide/formoterol fumarate combines:
| Component |
Pharmacologic class |
Function |
| Aclidinium bromide |
Long-acting muscarinic antagonist |
Blocks muscarinic receptors and reduces cholinergic bronchoconstriction |
| Formoterol fumarate |
Long-acting beta2-agonist |
Relaxes airway smooth muscle through beta2-receptor stimulation |
The combination is delivered through a multidose dry-powder inhaler. The United States product is Duaklir Pressair, administered as one inhalation twice daily. The FDA approved Duaklir Pressair in May 2019 for the long-term maintenance treatment of airflow obstruction in patients with COPD. It is not indicated for the treatment of acute bronchospasm or asthma. (U.S. Food and Drug Administration [FDA], 2019)
Aclidinium was previously commercialized as Tudorza Pressair in the United States. The combination therefore entered the market with an established LAMA component but faced competition from products offering once-daily dosing, broader clinical familiarity or triple therapy.
When did Duaklir Pressair receive FDA approval and exclusivity?
The FDA approved Duaklir Pressair on May 29, 2019, under New Drug Application 210595. Because aclidinium and formoterol had already been approved as separate active ingredients, the combination was not positioned as a conventional five-year new chemical entity exclusivity product.
The principal U.S. regulatory timeline is:
| Event |
Date |
| FDA approval of Tudorza Pressair |
2012 |
| FDA approval of Duaklir Pressair |
May 29, 2019 |
| Likely three-year new clinical investigation exclusivity period |
Through May 29, 2022 |
| Current commercial status |
Marketed, with U.S. rights held outside AstraZeneca after divestment |
The three-year exclusivity framework generally blocks approval of an abbreviated application relying on the new clinical investigations for the protected change. It does not create the same five-year barrier associated with a new active moiety. FDA Orange Book patent listings, rather than regulatory exclusivity alone, are the more relevant issue for generic timing. (FDA, 2024a)
What companies commercialize aclidinium/formoterol products?
Commercial rights have been divided among the originators and regional partners.
AstraZeneca and Covis Pharma
AstraZeneca acquired U.S. rights to Tudorza Pressair and Daliresp from Actavis in 2016. AstraZeneca later commercialized Duaklir Pressair in the United States. In 2021, AstraZeneca agreed to transfer U.S. commercial rights for Tudorza Pressair and Duaklir Pressair to Covis Pharma. The transaction followed AstraZeneca’s portfolio rationalization in respiratory medicines. (AstraZeneca, 2021)
Covis Pharma assumed U.S. commercialization of the products, while AstraZeneca retained manufacturing or other rights under the applicable transaction arrangements. Public filings did not provide a detailed product-level sales forecast or a separately reported acquisition price for the Duaklir rights.
Almirall
Almirall has been closely associated with aclidinium-based respiratory products outside the United States. The company commercialized Eklira Genuair and Duaklir Genuair in various markets and has reported respiratory-product revenue in aggregate rather than consistently disclosing a separate global figure for the combination.
Regional licensing structure
The product’s commercial footprint has depended on geography-specific rights, local registrations and inhaler supply. This structure reduces the usefulness of a single global sales estimate. U.S. ownership, European commercialization and manufacturing rights have not been fully aligned under one commercial entity.
How large is the market for aclidinium/formoterol?
Aclidinium/formoterol occupies the maintenance COPD LAMA/LABA segment. That segment is clinically established but commercially crowded.
The main competing products include:
| Product |
Active ingredients |
Dosing or device profile |
Competitive position |
| Duaklir Pressair |
Aclidinium/formoterol |
Twice-daily dry powder |
Established but non-leading |
| Anoro Ellipta |
Umeclidinium/vilanterol |
Once-daily dry powder |
Strong convenience positioning |
| Stiolto Respimat |
Tiotropium/olodaterol |
Once-daily soft mist |
Strong physician familiarity |
| Bevespi Aerosphere |
Glycopyrrolate/formoterol |
Twice-daily metered-dose aerosol |
Alternative device and molecule profile |
| Utibron Neohaler |
Glycopyrrolate/indacaterol |
Twice-daily dry powder |
Reduced commercial relevance after portfolio changes |
| Ultibro Breezhaler |
Glycopyrronium/indacaterol |
Once-daily dry powder |
Ex-U.S. competitor |
| Trelegy Ellipta |
Fluticasone/umeclidinium/vilanterol |
Once-daily triple therapy |
Important step-up competitor |
The most important commercial pressure comes from once-daily LAMA/LABA products and inhaled corticosteroid/LAMA/LABA triple therapies. COPD treatment increasingly rewards simplified dosing, inhaler familiarity and escalation pathways. Duaklir’s twice-daily schedule creates a convenience disadvantage where formularies do not favor its net price.
There is no reliable public source that reports a standalone global market share for Duaklir. AstraZeneca, Almirall and Covis have generally disclosed respiratory portfolios in aggregate or have excluded individual low-scale products from headline financial reporting.
What is the financial trajectory of aclidinium/formoterol?
The product’s financial trajectory is better characterized as stable-to-declining mature-brand revenue than as a growth asset.
Revenue disclosure
Public company reporting does not provide a consistent, audited global revenue line for aclidinium/formoterol. Revenue may be embedded in:
- AstraZeneca’s respiratory portfolio before the U.S. divestment;
- Almirall’s respiratory segment;
- Covis Pharma’s private-company commercial portfolio; and
- Regional license and supply transactions.
This limits direct valuation based on product-level revenue. Analysts typically model the asset using prescription trends, payer access, average net price, channel inventory and expected generic entry rather than relying on reported brand sales.
Financial trajectory by phase
| Period |
Financial profile |
Primary driver |
| 2019-2021 |
Launch and portfolio buildout |
FDA approval, U.S. launch, payer contracting |
| 2021-2022 |
Ownership transition |
Transfer of U.S. rights to Covis |
| 2022-2024 |
Mature branded product |
Formulary access, COPD persistence and regional sales |
| Post-generic entry |
Erosion phase |
ANDA competition, device substitution and price compression |
The product has limited probability of becoming a major growth driver without a material label expansion, combination strategy, device innovation or favorable formulary repositioning. Its economic value is more likely to come from recurring cash flow in selected territories than from global market expansion.
What patents protect aclidinium bromide/formoterol?
Protection is likely to consist of several layers:
- Drug-substance and salt patents covering aclidinium or formoterol forms.
- Combination patents covering the co-formulation of aclidinium and formoterol.
- Inhaler and dose-delivery patents covering the Pressair or Genuair device.
- Manufacturing and particle-engineering patents covering dry-powder production.
- Method-of-use claims covering maintenance treatment of COPD.
The practical patent estate is more important as a combination of formulation and device rights than as a single active-ingredient patent. A generic applicant may attempt to avoid one layer while challenging another.
Orange Book status
Duaklir Pressair is an FDA-approved small-molecule inhaled product and may have listed patents in the Orange Book covering the drug product or delivery system. Orange Book listings can include patents that expire after the principal regulatory exclusivity period. The FDA’s electronic Orange Book should be used to confirm the current patent numbers, listed claims, delisting status and expiration dates because listings can change through litigation, certifications or regulatory updates. (FDA, 2024a)
A product-specific analysis should distinguish:
- patents listed against Duaklir Pressair;
- patents listed against Tudorza Pressair;
- patents covering the device independently;
- patents that are expired but remain relevant to historical litigation; and
- unlisted formulation or manufacturing patents that may still support trade-secret or infringement claims.
When does aclidinium/formoterol lose exclusivity?
The key U.S. regulatory exclusivity period likely ended in 2022, based on the May 2019 approval date and the three-year exclusivity framework for new clinical investigations. Patent expiry may extend effective protection beyond that date.
The commercial loss-of-exclusivity date is therefore not necessarily the same as the FDA exclusivity date. The relevant sequence is:
- regulatory exclusivity expiration;
- Orange Book patent challenges;
- Paragraph IV litigation, if filed;
- approval of an ANDA or other abbreviated application;
- launch under a 180-day first-filer framework, if applicable; and
- subsequent multi-generic price erosion.
For an inhaled product, generic launch may occur later than the earliest theoretical patent expiry because the applicant must demonstrate device equivalence, establish dose uniformity and satisfy complex pharmaceutical-equivalence requirements.
What generic entry risks exist for Duaklir Pressair?
Generic risk is moderate but technically more complex than for a conventional tablet.
Paragraph IV exposure
An ANDA applicant can challenge listed patents through a Paragraph IV certification. The applicant may assert that a patent is invalid, unenforceable or not infringed. The branded sponsor can file an infringement action within 45 days, potentially triggering a 30-month stay of final ANDA approval under the Hatch-Waxman framework. (FDA, 2024b)
The principal risk variables are:
- whether combination patents remain unexpired;
- whether the Pressair device claims are listed and enforceable;
- whether the generic applicant proposes a sufficiently similar inhaler;
- whether the FDA accepts the proposed device as therapeutically equivalent; and
- whether a settlement permits an agreed launch date.
No broadly publicized, market-defining Paragraph IV settlement involving Duaklir Pressair had established a clear generic entry date through mid-2024. The absence of a reported settlement does not establish the absence of confidential certifications, pending litigation or regional challenges.
Device and manufacturing barriers
Dry-powder inhalers create barriers that are less significant for oral solid dosage forms. Generic manufacturers must address:
- powder aerodynamic performance;
- delivered-dose consistency;
- moisture control;
- capsule or blister handling;
- inhaler resistance and inspiratory-flow requirements;
- device reliability; and
- human-factors and usability requirements.
These barriers can support a longer period of branded pricing, but they do not eliminate generic risk. Once an FDA-designated therapeutically equivalent product is available, payer substitution can accelerate.
Are there biosimilar risks for aclidinium/formoterol?
There is no biosimilar risk because aclidinium bromide/formoterol fumarate is a chemically synthesized small-molecule combination, not a biologic.
The relevant competitive threats are:
- ANDA-approved generic combinations;
- authorized generic arrangements;
- single-agent substitution with separate LAMA and LABA products;
- formulary migration to once-daily combinations; and
- escalation to triple therapy.
The device component makes the product more complex than a standard tablet, but the regulatory route remains a small-molecule generic pathway rather than the biosimilar pathway.
How does aclidinium/formoterol compare with competing COPD combinations?
Duaklir’s main strength is dual bronchodilation with a familiar LAMA/LABA mechanism and established dry-powder delivery. Its main weakness is twice-daily dosing in a market where once-daily products and single-inhaler triple therapy have strong commercial positions.
| Factor |
Duaklir |
Once-daily LAMA/LABA |
Triple therapy |
| Bronchodilation |
Dual |
Dual |
Dual plus inhaled corticosteroid |
| Dosing convenience |
Twice daily |
Once daily |
Usually once daily |
| Exacerbation positioning |
Limited relative to triple therapy |
Depends on product |
Stronger for selected patients |
| Device differentiation |
Pressair/Genuair platform |
Ellipta, Respimat and other platforms |
Often integrated single inhaler |
| Generic complexity |
Moderate to high |
Moderate to high |
Higher because of three actives |
| Commercial outlook |
Mature and selective |
More favorable |
Strong where guideline escalation supports use |
The product is most defensible in patients or markets where the Pressair device is accepted, inhaled corticosteroid exposure is not desired and payer coverage supports twice-daily treatment.
What licensing deals affect the product?
The most commercially relevant transaction was AstraZeneca’s transfer of U.S. rights for Tudorza Pressair and Duaklir Pressair to Covis Pharma. The deal changed the product’s U.S. commercial owner and reduced AstraZeneca’s direct exposure to mature respiratory brands. (AstraZeneca, 2021)
Almirall’s regional rights and historical development arrangements also remain relevant. Commercial economics can differ materially by country because of:
- local reimbursement;
- tender pricing;
- patent status;
- device registration;
- supply responsibilities; and
- national substitution rules.
No major licensing event has transformed the product into a global growth asset. Its value remains tied to regional cash generation and the durability of its device and formulation protection.
What is the competitive and investment outlook?
The commercial outlook is defensive rather than expansionary.
Revenue exposure
For AstraZeneca, Duaklir was a small component of a broader respiratory portfolio dominated by larger products. Following the U.S. rights transfer, direct revenue exposure shifted toward Covis and regional partners. For Almirall, aclidinium-based products remain relevant to respiratory operations but are not comparable in scale to the company’s most important dermatology assets.
Patent strength
Patent strength is moderate. The product has more protection than an unpatented mature inhaler if combination, formulation and device patents remain enforceable. It has less strategic protection than a biologic, a first-in-class medicine or a product with broad, unexpired composition-of-matter claims.
Patent durability depends on:
- the remaining life of combination claims;
- the scope of device patents;
- the enforceability of particle and manufacturing claims;
- the number of viable generic inhaler designs; and
- the outcome of any Paragraph IV litigation.
Generic launch scenarios
| Scenario |
Timing |
Financial effect |
| No successful challenge |
Delayed entry |
Gradual mature-brand decline |
| Single generic entrant |
First approved product |
Moderate price and volume erosion |
| Multiple generic entrants |
Competitive launch wave |
Sharp net-price compression |
| Authorized generic or settlement launch |
Controlled entry |
Earlier erosion with potentially managed transition |
| Device-driven delay |
Later substitution |
Extended branded revenue period |
Key Takeaways
- Aclidinium bromide/formoterol fumarate is a mature LAMA/LABA COPD product marketed primarily as Duaklir Pressair or Duaklir Genuair.
- FDA approval occurred on May 29, 2019; the principal combination-product regulatory exclusivity period likely expired in 2022.
- U.S. commercial rights moved from AstraZeneca to Covis Pharma, while Almirall has held important non-U.S. commercial interests.
- Product-level revenue is not consistently disclosed, limiting precise valuation and financial forecasting.
- The product competes against once-daily LAMA/LABA inhalers and triple therapies, which constrain growth.
- Generic risk is moderate because dry-powder inhaler technology and device equivalence raise entry barriers.
- No biosimilar risk applies.
- The patent estate is likely strongest where combination, formulation, device and manufacturing claims overlap.
- The financial trajectory is more consistent with mature-brand cash generation and eventual erosion than with material long-term growth.
FAQs About Aclidinium Bromide/Formoterol Patent and Market Risk
Who owns Duaklir Pressair in the United States?
Covis Pharma acquired U.S. commercial rights from AstraZeneca. Regional manufacturing, supply and intellectual-property rights may remain divided under transaction and licensing agreements.
Is Duaklir Pressair still FDA approved?
Yes. Duaklir Pressair remains an FDA-approved maintenance treatment for COPD, subject to current labeling and commercial availability.
Is aclidinium/formoterol the same as Tudorza Pressair?
No. Tudorza Pressair contains aclidinium bromide alone. Duaklir Pressair combines aclidinium bromide with formoterol fumarate.
Can patients substitute separate aclidinium and formoterol inhalers?
Separate products may provide the same broad pharmacologic classes, but they are not automatically substitutable for the fixed-dose combination. Prescribing, reimbursement and device-specific considerations apply.
What is the largest commercial threat to Duaklir?
The largest threat is competitive migration to once-daily LAMA/LABA products or single-inhaler triple therapy, followed by generic fixed-dose combination entry once device and patent barriers are overcome.
References
-
AstraZeneca. (2021). Annual report 2021. AstraZeneca PLC.
-
AstraZeneca. (2021). AstraZeneca agrees to divest US rights for Tudorza and Duaklir to Covis Pharma. AstraZeneca PLC.
-
Almirall, S.A. (2023). Annual report 2023. Almirall, S.A.
-
U.S. Food and Drug Administration. (2019). Drug approval package: Duaklir Pressair, NDA 210595. U.S. Department of Health and Human Services.
-
U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Electronic Orange Book. U.S. Department of Health and Human Services.
-
U.S. Food and Drug Administration. (2024b). Hatch-Waxman amendments and abbreviated new drug applications. U.S. Department of Health and Human Services.
