GLYCOPYRROLATE; INDACATEROL MALEATE - Generic Drug Details

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

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

Glycopyrrolate; indacaterol maleate has one hundred and forty-eight patent family members in forty countries.

Summary for GLYCOPYRROLATE; INDACATEROL MALEATE

International Patents:	148
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	GLYCOPYRROLATE; INDACATEROL MALEATE at DailyMed

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

Constraining patent/regulatory exclusivity:

8,479,730

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.

Anatomical Therapeutic Chemical (ATC) Classes for GLYCOPYRROLATE; 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 GLYCOPYRROLATE; 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	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	8,479,730		Y
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	8,182,838		Y
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	6,878,721		Y	Y

Expired US Patents for GLYCOPYRROLATE; INDACATEROL MALEATE

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	8,283,362
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	9,931,304
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,658,673
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	7,736,670
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,067,437
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	6,521,260
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	9,962,338

International Patents for GLYCOPYRROLATE; INDACATEROL MALEATE

Country	Patent Number	Title	Estimated Expiration
Norway	20015912
Russian Federation	2364400	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)
Japan	3785365
Japan	2012071146	INHALER
Germany	60042781
United Kingdom	0412562
Denmark	1747036

Supplementary Protection Certificates for GLYCOPYRROLATE; INDACATEROL MALEATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240	91651	Luxembourg		91651, EXPIRES: 20241130
1183240	SPC009/2010	Ireland		SPC009/2010: 20100813, EXPIRES: 20241129
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 [...]
1183240	SZ 7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
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

Market Dynamics and Financial Trajectory for Glycopyrrolate and Indacaterol Maleate

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for chronic respiratory and specialized treatments continues to evolve, driven by increasing prevalence of respiratory diseases and advances in targeted therapies. Among notable drugs, glycopyrrolate and indacaterol maleate occupy critical positions within their respective therapeutic categories, with distinct market dynamics and financial trajectories shaped by regulatory developments, clinical efficacy, competitive landscapes, and unmet medical needs.

This analysis explores the current market environment, growth drivers, challenges, and forecasted financial performance associated with glycopyrrolate and indacaterol maleate, offering insights for stakeholders in investment, R&D, and strategic planning.

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Glycopyrrolate: Market Overview and Dynamics

Therapeutic Indications and Market Position

Glycopyrrolate is a long-acting muscarinic antagonist (LAMA) primarily used to reduce secretions preoperatively, manage peptic ulcers, and more recently, treat chronic obstructive pulmonary disease (COPD). Its inhaled formulation, Glycopyrrolate Inhalation Solution (e.g., Robinul®), has gained prominence in COPD management, especially as an alternative to tiotropium and aclidinium (per recent guidelines and clinical trials).

The drug's repositioning in respiratory therapy has enhanced its market prospects, particularly with the advent of combination inhalers and innovative delivery devices.

Market Drivers

• Rising COPD Prevalence: Globally, COPD affects over 200 million people, with projections indicating a continued upward trend exacerbated by smoking, pollution, and aging populations (WHO). Glycopyrrolate’s targeted action and favorable safety profile position it as a vital component in COPD management algorithms.
• Regulatory Approvals and Label Expansions: Recent approvals for specific formulations and indications extend market reach, supported by positive clinical trial outcomes highlighting efficacy and safety.
• Patient-centric Delivery Devices: The development of user-friendly inhalation devices improves adherence, boosting prescriptions and reimbursement coverage.

Market Challenges

• Intense Competition: Glycopyrrolate faces competition from established LAMAs such as tiotropium, glycopyrronium (marketed as Seebri®), and emerging fixed-dose combination therapies.
• Patent and Generic Entry: Patent expirations in key markets, notably the US and Europe, lead to potential generic erosion, exerting downward pressure on pricing.
• Market Penetration Barriers: Provider familiarity with existing therapies and the need for education around new formulations or indications can slow adoption.

Financial Trajectory and Forecasts

Analysts project the global inhaled glycopyrrolate market to grow at a CAGR of approximately 6-8% over the next five years, driven by expanding COPD treatment adoption and innovation (notably in combination therapies). Revenue estimates for glycopyrrolate inhalation products are expected to reach USD 1.2 billion by 2028, from an estimated USD 700 million in 2023.

Emerging markets in Asia-Pacific show considerable growth potential due to increasing healthcare infrastructure and COPD awareness. Pricing strategies, patent rights, and R&D investments in next-generation inhalers will significantly influence financial outcomes.

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Indacaterol Maleate: Market Overview and Dynamics

Therapeutic Indications and Market Position

Indacaterol maleate is a once-daily LABA (long-acting beta-agonist) indicated primarily for COPD and, increasingly, for asthma. Its rapid onset and sustained bronchodilation position it favorably among long-acting bronchodilators, often used as monotherapy or in combination with corticosteroids.

Market Drivers

• Enhanced Patient Compliance: Once-daily dosing enhances adherence compared to multiple-dose regimens, a pivotal factor driving prescriptions.
• Strong Clinical Evidence: Multiple trials demonstrate non-inferiority or superiority over competing LABAs, along with a favorable safety profile.
• Combination Therapies: Indacaterol is frequently combined with glycopyrrolate or fluticasone, creating multi-agent inhalers that improve outcomes and drive market share growth.

Market Challenges

• Therapeutic Competition: The presence of alternative LABAs like salmeterol, vilanterol, and olodaterol limits market share gains.
• Pricing and Patent Expiry Risks: Some formulations face patent challenges; generic versions threaten profit margins.
• Regulatory Nuances: Varying approvals across regions and delays in indication expansions can restrain revenue growth.

Financial Projection and Market Outlook

The global indacaterol maleate market is forecast to expand at a CAGR of roughly 5-7% through 2028. Expected revenues are projected to hit USD 1 billion in this period, up from around USD 600 million in 2023. North America remains the largest market, driven by high COPD prevalence and healthcare infrastructure. Asia-Pacific's rapid urbanization and smoking rates further support long-term growth.

Innovative inhaler devices and combination formulations integrating indacaterol maleate are expected to elevate sales. Strategic partnerships and patent rights management will play crucial roles in shaping the financial outlook.

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Market Interplay and Strategic Implications

Synergies Between Glycopyrrolate and Indacaterol Maleate

Both drugs are pivotal in COPD management, particularly in combination therapies that optimize bronchodilation and improve patient outcomes. The burgeoning interest in fixed-dose combinations (e.g., indacaterol with glycopyrrolate) underscores their complementary roles, presenting opportunities for market expansion and increased revenue streams.

Regulatory and R&D Trends

Regulators are increasingly favoring combination inhalers for their efficacy and convenience. R&D investments targeting long-acting formulations, improved delivery devices, and novel indications are central to maintaining competitive advantage. Companies that secure patents and expand indications ahead of competitors will benefit financially.

Market Risks and Opportunities

Patent expirations threaten price levels, but innovation in inhaler technology and expanding indications can offset erosion. Entering emerging markets early and building robust post-market surveillance for safety signals can underpin revenue growth.

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Conclusion

The market for glycopyrrolate and indacaterol maleate remains robust, driven by the global surge in COPD prevalence and ongoing clinical innovations. While competitive pressures and patent landscapes challenge profitability, strategic investments in R&D, device technology, and market expansion can foster sustained financial growth.

Investors and pharmaceutical companies should prioritize partnerships and pipeline advancements, leveraging regulatory trends favoring combination therapies. In a landscape that demands continuous innovation, firms that develop differentiated, patient-centric delivery solutions will maximize market share and revenues.

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Key Takeaways

• The global COPD treatment market is expanding, with glycopyrrolate and indacaterol maleate positioned as key players, with projected revenue growth to USD 2.2 billion combined by 2028.
• Competitive dynamics, including patent cliffs and generic threats, require strategic innovation and patent management to sustain profitability.
• The growing acceptance of combination inhalers and device innovations offer significant revenue opportunities but necessitate early R&D investments.
• Emerging markets present high-growth potential, driven by increasing disease burden and healthcare infrastructure development.
• Regulatory trends favoring fixed-dose combination therapies will likely accelerate market penetration and revenue streams for both drugs.

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FAQs

Q1: How does the competitive landscape impact glycopyrrolate’s financial outlook?
The presence of established LAMAs like tiotropium and glycopyrronium, along with patent expirations, intensifies price competition. Companies that innovate delivery devices and expand indications can offset generic erosion and capitalize on market demand.

Q2: What are the primary growth drivers for indacaterol maleate?
Once-daily dosing, proven clinical efficacy, and combination formulations enhance adherence and outcomes. Regulatory approvals in emerging markets and ongoing R&D into new indications further propel growth.

Q3: How do combination therapies influence market dynamics?
Combination inhalers improve patient compliance, streamline treatment, and often lead to higher pricing and reimbursement levels, thereby increasing overall market revenue.

Q4: What risks do patent expirations pose to the financial performance of these drugs?
Patent expirations open pathways for generics, reducing market exclusivity and significantly impacting profit margins unless replaced by innovative formulations or new indications.

Q5: Which markets hold the highest future growth potential?
North America remains the largest market, but Asia-Pacific's rapid urbanization, smoking prevalence, and healthcare access lend it high growth potential, especially with localized regulatory strategies.

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References:
[1] World Health Organization. Global surveillance, prevention and control of chronic respiratory diseases. 2021.
[2] MarketWatch. 2023 COPD inhaler market analysis.
[3] ClinicalTrials.gov. Recent studies on glycopyrrolate and indacaterol.
[4] Fitch Solutions. Pharmaceutical market forecasts 2023-2028.
[5] FDA and EMA approval databases.