UTIBRON NEOHALER Drug Patent Profile

When do Utibron Neohaler patents expire, and what generic alternatives are available?

Utibron Neohaler is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and forty-eight patent family members in forty countries.

The generic ingredient in UTIBRON NEOHALER is glycopyrrolate; indacaterol maleate. There are seventeen drug master file entries for this compound. Additional details are available on the glycopyrrolate; indacaterol maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Utibron Neohaler

Utibron Neohaler was eligible for patent challenges on July 1, 2015.

Indicators of Generic Entry

Summary for UTIBRON NEOHALER

International Patents:	148
US Patents:	3
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for UTIBRON NEOHALER
What excipients (inactive ingredients) are in UTIBRON NEOHALER?	UTIBRON NEOHALER excipients list
DailyMed Link:	UTIBRON NEOHALER at DailyMed

See drug prices for UTIBRON NEOHALER

US Patents and Regulatory Information for UTIBRON NEOHALER

UTIBRON NEOHALER is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y	Y
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No			Y

Expired US Patents for UTIBRON NEOHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015

International Patents for UTIBRON NEOHALER

See the table below for patents covering UTIBRON NEOHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4914345
New Zealand	543026	Pharmaceutical compositions comprising apomorphine for pulmonary inhalation
Hong Kong	1092068	DRY POWDER COMPOSITION COMPRISING CO-JET MILLED PARTICLES FOR PULMONARY INHALATION
Denmark	1913939
Portugal	1920763
Denmark	1232745
New Zealand	521972	Improvements in or relating to formulations for use in inhaler devices

Supplementary Protection Certificates for UTIBRON NEOHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	CR 2013 00015	Denmark		PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
1267866	SPC/GB13/020	United Kingdom		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928
1267866	C01267866/02	Switzerland		FORMER OWNER: SOSEI R&D LTD., GB
1267866	2013C/023	Belgium		PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002
1183240	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
1267866	C300583	Netherlands		PRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928

Market Dynamics and Financial Trajectory for UTIBRON NEOHALER

Last updated: July 30, 2025

Introduction

UTIBRON NEOHALER, a combination inhaler developed by AstraZeneca, represents a significant advancement in the management of chronic obstructive pulmonary disease (COPD). Combining indacaterol, a long-acting beta-2 adrenergic agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), UTIBRON NEOHALER offers a dual mechanism of action designed to improve patient outcomes. As the global COPD therapeutics market evolves, understanding UTIBRON NEOHALER’s market dynamics and financial trajectory is essential for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers.

Market Landscape and Competitive Positioning

Global COPD Market Overview

The COPD therapeutics market is projected to surpass USD 12 billion by 2027, driven by increasing prevalence, aging populations, and unmet clinical needs [1]. The disease burden is most pronounced in regions like North America, Europe, and parts of Asia-Pacific, where healthcare infrastructure supports advanced therapeutics. The increasing adoption of inhaled medications, especially combo inhalers, reflects a shift toward therapies that enhance adherence and efficacy.

UTIBRON NEOHALER’s Position in the Market

UTIBRON NEOHALER entered a competitive landscape with established players like GlaxoSmithKline’s Advair (fluticasone/salmeterol), Boehringer Ingelheim’s Spiriva (tiotropium), and other combination inhalers. Its unique formulation—combining indacaterol and glycopyrrolate—offers rapid onset and sustained bronchodilation, positioning it as an effective option for COPD maintenance therapy.

The inhaler’s approval in the U.S. (2017) and subsequent expansions in Europe and emerging markets have contributed to its growing market share. Its advantages include simplified dosing regimens and improved symptom control, appealing to both clinicians and patients.

Competitive Dynamics

The competitive edge of UTIBRON NEOHALER hinges on its dual-action mechanism, safety profile, and ease of use. However, the therapeutic landscape faces challenges from generic alternatives, patent cliffs, and the proliferation of new inhaler formulations. Additionally, strong marketing strategies by rivals and increasing use of triple therapy inhalers (LABA/LAMA/ICS) influence market dynamics.

Market Drivers and Inhibitors

Drivers

• Rising COPD Prevalence: Global COPD cases are projected to reach over 200 million by 2030, predominantly driven by smoking and exposure to environmental pollutants [2].
• Aging Population: Elderly populations are more susceptible, creating higher demand for long-term maintenance therapies like UTIBRON NEOHALER.
• Increased Awareness and Diagnosis: Improved diagnostic practices are expanding the treated patient base.
• Shift Toward Dual and Triple Therapy: Evidence favors inhalers offering multiple mechanisms, increasing demand for fixed-dose combinations like UTIBRON NEOHALER.

Inhibitors

• Patent Expiry and Generics: Patent attrition could erode market exclusivity, leading to generic competition.
• Pricing Pressures: Cost containment policies across healthcare systems can limit price growth.
• Therapeutic Alternatives: The rise of triple therapy inhalers (e.g., budesonide/formoterol/glycopyrrolate) could reduce reliance on dual-agent inhalers.
• Regulatory Challenges: Diverse regulatory landscapes may delay market expansion in emerging regions.

Financial Trajectory and Revenue Projections

Historical Performance

Since its FDA approval in 2017, UTIBRON NEOHALER has demonstrated steady adoption, supported by clinical evidence and strategic marketing. AstraZeneca reported strong COPD franchise growth, with inhaler sales contributing substantially ([3]).

Future Revenue Outlook

Projections indicate that the COPD inhaler segment, including UTIBRON NEOHALER, will maintain a compound annual growth rate (CAGR) of approximately 4-6% through 2030, driven by increasing prevalence and expanding geographic access. The global expansion into emerging markets, where COPD diagnosis rates are rising, could boost revenues.

Market Penetration Strategies

AstraZeneca’s focus on clinical education, patient adherence programs, and strategic partnerships enhances UTIBRON NEOHALER’s market trajectory. The launch of newer inhaler devices and combination therapies tailored for specific patient subgroups will further influence sales.

Impact of Patent and Competition

Patent protections in the U.S. and Europe secure exclusivity until mid-2020s, supporting revenue stability. However, impending patent expirations could precipitate revenue declines unless mitigated by label extensions, formulations, or new indications.

Regulatory and Market Expansion Outlook

Emerging markets, particularly in Asia-Pacific and Latin America, present lucrative opportunities. Regulatory approvals in these regions are poised to unlock new patient populations. Continued clinical development to demonstrate broader efficacy and safety profiles could underpin label expansions, further elevating Britannia’s market dosing.

Pricing and Reimbursement Landscape

Pricing strategies vary by region, with premium positioning in high-income markets justified by clinical benefits and convenience. Governments and insurers are increasingly adopting value-based reimbursement models, emphasizing cost-effective COPD management solutions. These trends could influence profitability and market access strategies for UTIBRON NEOHALER.

Key Risks and Mitigation Strategies

• Generic Entry: Developing multiple formulations and obtaining new indications can extend patent life and defend market share.
• Market Saturation: Focused marketing and post-marketing studies reinforce the inhaler’s clinical advantages.
• Regulatory Delays: Early engagement with regulatory agencies ensures smoother approval processes in new regions.
• Pricing Pressures: Demonstrating cost-effectiveness through real-world evidence supports favorable reimbursement terms.

Conclusion

UTIBRON NEOHALER’s market dynamics are shaped by the global rise in COPD prevalence, evolving therapeutic standards, and strategic regulatory and marketing initiatives. Its financial trajectory is poised for steady growth, contingent on patent protection, competitive positioning, and expansion into emerging markets. Continuous innovation and deployment of comprehensive clinical data will be crucial to maintaining its market relevance and optimizing revenue streams.

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Key Takeaways

• Competitive Position: UTIBRON NEOHALER holds a strategic advantage due to its dual-mechanism inhalation therapy, with strong growth prospects in COPD management.
• Market Growth: A CAGR of 4-6% is forecast for the inhaler segment through 2030, driven by increasing COPD prevalence and aging demographics.
• Expansion Opportunities: Emerging markets and label expansions are critical for sustaining revenue growth.
• Challenges: Patent cliffs, pricing pressures, and competitive therapies necessitate proactive lifecycle management.
• Strategic Focus: Ongoing clinical research, regional regulatory engagement, and adherence programs are pivotal for maximizing financial returns.

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FAQs

1. How does UTIBRON NEOHALER differ from other COPD inhalers?
UTIBRON NEOHALER uniquely combines indacaterol (a LABA) with glycopyrrolate (a LAMA) in a single device, offering rapid onset and sustained bronchodilation, which improves symptom control compared to monotherapies or other combinations.

2. What are the primary markets for UTIBRON NEOHALER?
The primary markets include North America and Europe, with expanding opportunities in Asia-Pacific, Latin America, and the Middle East, driven by increasing COPD diagnoses and healthcare infrastructure improvements.

3. When are patent protections for UTIBRON NEOHALER expected to expire?
Patent protections are anticipated to extend until mid-2020s; however, patent extensions, new formulations, or additional indications may prolong market exclusivity.

4. How is reimbursement landscape shaping for inhalers like UTIBRON NEOHALER?
Reimbursement policies increasingly favor value-based models that reward clinical benefit, influencing pricing strategies and access decisions across healthcare systems.

5. What is the outlook for novel formulations or delivery mechanisms for UTIBRON NEOHALER?
Innovation in inhaler devices and combination therapies, along with real-world evidence demonstrating improved adherence and outcomes, will support market expansion and sustained revenue growth.

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References

[1] Market Research Future, "Global COPD Therapeutics Market," 2022.
[2] World Health Organization, "Chronic Obstructive Pulmonary Disease (COPD)," 2021.
[3] AstraZeneca Annual Report, 2022.