INDACATEROL MALEATE - Generic Drug Details

What are the generic drug sources for indacaterol maleate and what is the scope of freedom to operate?

Indacaterol maleate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indacaterol maleate has eighty-six patent family members in thirty-nine countries.

Summary for INDACATEROL MALEATE

International Patents:	86
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	24
DailyMed Link:	INDACATEROL MALEATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INDACATEROL MALEATE

Dosage:

POWDER;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.

Recent Clinical Trials for INDACATEROL MALEATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mundipharma Research Limited	Phase 2/Phase 3
Novartis Pharmaceuticals	Phase 4
Novartis Pharmaceuticals	Phase 3

See all INDACATEROL MALEATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for INDACATEROL MALEATE

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for INDACATEROL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No			Y
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No			Y	Y

Expired US Patents for INDACATEROL MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011

International Patents for INDACATEROL MALEATE

Country	Patent Number	Title	Estimated Expiration
Portugal	2332915
Russian Federation	2363501	ИНГАЛЯТОР (INHALER)
Brazil	0011324	Agonistas de Adrenoceptores Beta 2, Processo de Preparação dos Mesmos, seu Uso e Composição Farmacêutica compreendendo os mesmos
European Patent Office	2332915	Agonistes du beta-2-adrenorecepteur (Beta2-adrenoceptor agonists)
New Zealand	515669	Beta 2 adrenoceptor agonists
Spain	2362429
Slovakia	287260

Supplementary Protection Certificates for INDACATEROL MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	SPC/GB10/009	United Kingdom		PRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
1183240	CA 2010 00006	Denmark		PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1183240	SZ 7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240	91651	Luxembourg		91651, EXPIRES: 20241130
1183240	7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1267866	122014000025	Germany		PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
1183240	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Indacaterol Maleate

Last updated: July 28, 2025

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Introduction

Indacaterol maleate, a long-acting β2-agonist (LABA), has gained prominence in the management of chronic obstructive pulmonary disease (COPD), with recent expansion into asthma treatment. Its unique pharmacological profile, combined with increasing global COPD prevalence, positions indacaterol maleate as a pivotal asset within the respiratory therapeutics landscape. Analyzing market dynamics and financial trajectories reveals strategic opportunities and challenges for pharmaceutical stakeholders.

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Pharmacological Profile and Therapeutic Significance

Indacaterol maleate offers 24-hour bronchodilation with once-daily dosing, improving patient adherence and quality of life. Approved primarily in 2011 in Europe (by Novartis, the innovator), its efficacy surpasses traditional short-acting bronchodilators, fostering uptake among clinicians. The drug’s inhalation therapy mechanism minimizes systemic side effects, bolstering its safety profile.

This drug’s therapeutic niche extends beyond COPD. Regulatory approvals in Japan and Europe, coupled with ongoing research into asthma indications, suggest potential expansion. The sustained clinical demand stems from its efficacy, tolerability, and convenience—factors resonating with aging populations.

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Market Dynamics

Global COPD Burden and Respiratory Disease Trends

COPD remains a leading cause of mortality, with an estimated 251 million cases globally (WHO, 2021). Its rising prevalence, especially in Asia and emerging markets, underpins sustained demand for novel long-acting bronchodilators like indacaterol maleate. The World Health Organization projects COPD to be the third-leading cause of death worldwide by 2030.

Similarly, asthma's global prevalence (~262 million cases) is rising, attracting attention for potential off-label or expanded indications of indacaterol maleate. Regulatory agencies are actively reviewing data to extend approval for this indication, potentially broadening market scope.

Competitive Landscape

Indacaterol maleate competes within a crowded respiratory drug market, including:

• Other LABAs: Olodaterol, vilanterol
• Combination therapies: Fluticasone/salmeterol, formoterol/budesonide

Notably, indacaterol’s once-daily dosing provides a competitive edge over twice-daily counterparts, influencing prescription patterns.

Major pharmaceutical players like Novartis, Sunovion, and GSK extensively market indacaterol or combination regimens including indacaterol derivatives. Patent expirations and biosimilar development could pressure pricing, although patent protections continue to sustain revenue streams.

Regulatory and Reimbursement Environment

Professional guidelines, such as GOLD (Global Initiative for Chronic Obstructive Lung Disease), recommend long-acting bronchodilators, including indacaterol, as first-line therapy. Reimbursement policies favor innovative inhalers with proven efficacy, often supporting premium pricing strategies. Conversely, cost containment measures in developing economies pose challenges, requiring pricing strategies aligned with local healthcare budgets.

Market Penetration and Adoption Dynamics

Early peak adoption occurred in Europe and Japan—markets with advanced healthcare infrastructure and high COPD prevalence. Adoption is progressing in North America, although regulatory delays and market saturation have tempered growth rates. Emerging markets such as China, India, and Brazil exhibit high growth potential driven by expanding healthcare coverage and rising disease burden.

Physician familiarity, patient preferences, and formulary inclusion are critical determinants for market penetration. The advent of combination inhalers incorporating indacaterol enhances adherence and drives revenue, leveraging formulary exclusivity.

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Financial Trajectory

Revenue Trends and Projections

Since initial approval, indacaterol maleate’s global sales have grown steadily. In 2022, the respiratory pharmaceuticals segment, including indacaterol-based inhalers, amassed an estimated $15 billion globally, with indacaterol's market share projected to increase at a CAGR of 6-8% through 2030 (Sources: EvaluatePharma, 2022).

The primary revenue streams derive from:

• Brand-Name Sales: Novartis’s Ultibro Breezhaler and other branded combinations
• NDA and Patent Strategies: Ongoing patent protections sustain pricing power; biosimilar threats remain distant but imminent

Impact of Patent Expirations

Patent expiry timelines vary—Novartis’s core patents on indacaterol inhalers extend into the late 2020s. Patent cliffs could induce revenue erosion unless diversified through pipeline innovations or combination therapies. Generic competition, while currently limited, threatens future profitability.

Research and Development Investments

Significant expenditure targeting expanded indications (e.g., asthma), delivery system improvements, and combination therapy formulations underpin future growth. Budget allocations correspond with promising clinical trial results, possibly translating into new revenue streams over the next 5–7 years.

Pricing and Reimbursement Strategies

Pricing models vary by geography. Premium pricing persists in developed markets owing to clinical advantages and inhaler convenience, balancing cost-effectiveness considerations. Reimbursement agencies increasingly favor value-based assessments, influencing future revenue potential.

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Emerging Opportunities and Challenges

Market Expansion into Developing Economies

Massive populations with high COPD and asthma prevalence represent scalable markets. Challenges include pricing affordability, supply chain logistics, and regulatory hurdles. Local manufacturing, licensing agreements, and tiered pricing can mitigate these barriers.

Pipeline Development and Biosimilar Competition

Although biosimilars for indacaterol remain in early stages, patent expirations will attract competitors, demanding continuous innovation. Development of combination inhalers and personalized medicine approaches could offset impending generic competition.

Regulatory and Policy Shifts

Policy shifts favoring biosimilars and generic drugs could diminish branded drug revenues. Conversely, regulatory support for inhaler devices with improved delivery efficacy could bolster sales.

COVID-19 Impact

The pandemic disrupted healthcare services, affecting diagnosis and prescription rates. However, increased focus on respiratory health augurs well for long-term demand. Telemedicine adoption also influences patient management paradigms.

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Conclusion

Indacaterol maleate’s market dynamics are intricately linked to the global burden of COPD and asthma, evolving regulatory landscapes, and technological innovations in inhaler delivery systems. Its financial trajectory hinges on strategic patent management, expanding indications, and penetration into emerging markets. Continued R&D investments and tailored market entry strategies will shape its growth trajectory, ensuring sustained revenue streams amid competitive pressures.

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Key Takeaways

• Growth Drivers: Increasing COPD prevalence, patient adherence advantages, and favorable clinical profile support steady demand.
• Market Challenges: Patent expirations, biosimilar threats, and regional pricing constraints necessitate innovation and strategic planning.
• Expansion Opportunities: Emerging markets, new indications (e.g., asthma), and combination therapy formulations are pivotal.
• Regulatory Landscape: Favorable guidelines enhance adoption; policy shifts toward biosimilars could influence pricing strategies.
• Strategic Focus: Investment in pipeline development, personalized medicine, and device innovation will underpin future profitability.

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FAQs

1. What factors influence the market share of indacaterol maleate globally?
Market share is driven by disease prevalence, clinician prescribing habits, regulatory approvals, competitive therapies, pricing strategies, and patient adherence incentives.

2. How does patent expiration impact indacaterol maleate’s revenue prospects?
Patent expiry exposes the drug to generic competition, typically leading to price reductions and volume-driven sales, unless offset by pipeline innovations or brand loyalty.

3. What are the key growth markets for indacaterol maleate?
Emerging economies such as China, India, and Brazil represent significant growth opportunities due to rising respiratory disease burden and expanding healthcare infrastructure.

4. How are regulatory policies affecting indacaterol maleate’s market expansion?
Regulatory approvals influence access and reimbursement; supportive guidelines increase adoption, whereas delays and restrictive policies could hinder growth.

5. What future innovations could extend indacaterol maleate’s market life?
Development of combination therapies, inhaler device improvements, and new indications like asthma are potential avenues for sustained revenue.

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References

[1] World Health Organization. Global Surveillance, Prevention and Control of Chronic Respiratory Diseases: a comprehensive approach. 2021.
[2] EvaluatePharma. 2022 World Preview: Outlook to 2027.
[3] GOLD Reports. Global Initiative for Chronic Obstructive Lung Disease, 2022.