SEEBRI NEOHALER Drug Patent Profile

Which patents cover Seebri Neohaler, and what generic alternatives are available?

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

This drug has ninety-nine patent family members in thirty-two countries.

The generic ingredient in SEEBRI NEOHALER is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Seebri Neohaler

A generic version of SEEBRI NEOHALER was approved as glycopyrrolate by AM REGENT on July 23^rd, 1986.

Summary for SEEBRI NEOHALER

International Patents:	99
US Patents:	2
Applicants:	1
NDAs:	1
Drug Prices:	Drug price information for SEEBRI NEOHALER
What excipients (inactive ingredients) are in SEEBRI NEOHALER?	SEEBRI NEOHALER excipients list
DailyMed Link:	SEEBRI NEOHALER at DailyMed

See drug prices for SEEBRI NEOHALER

US Patents and Regulatory Information for SEEBRI NEOHALER

SEEBRI NEOHALER is protected by two 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	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No			Y
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015		DISCN	Yes	No			Y

Expired US Patents for SEEBRI NEOHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015
Novartis	SEEBRI NEOHALER	glycopyrrolate	POWDER;INHALATION	207923-001	Oct 29, 2015

International Patents for SEEBRI NEOHALER

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

Country	Patent Number	Title	Estimated Expiration
Norway	20060978
Poland	204251
China	101181263
Norway	324037

Supplementary Protection Certificates for SEEBRI NEOHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	92393	Luxembourg		PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923
1267866	132014902244065	Italy		PRODUCT NAME: INDACATEROLO O UN SUO SALE, IN PARTICOLARE IL SALE MALEATO, E GLICOPIRRONIO O UN SUO SALE, IN PARTICOLARE IL SALE BROMURO, IN ASSOCIAZIONE(ULTIBRO BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/862, 20130919
1267866	CA 2013 00015	Denmark
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210

Market Dynamics and Financial Trajectory for SEEBRI NEOHALER

Last updated: July 27, 2025

Introduction

SEEBRI NEOHALER, a brand of inhalation powder utilized predominantly in the management of chronic obstructive pulmonary disease (COPD), has established itself amid a competitive respiratory therapeutics market. Its market performance hinges on robust clinical efficacy, strategic positioning, and evolving healthcare trends. Analyzing the current market landscape and projecting its financial trajectory involves examining key industry drivers, competitive pressures, regulatory influences, and patient demand patterns.

Market Landscape and Competitive Positioning

Therapeutic Indications and Market Demand

SEEBRI NEOHALER's primary indication for COPD positions it within a substantial global market segment. According to the Global COPD Drugs Market report, the COPD therapeutics segment is projected to reach USD 27.4 billion by 2027, growing at a CAGR of 5.3% (source: [1]). The increasing prevalence of COPD, driven by aging populations and rising smoking rates, correlates directly with increased demand for inhaled therapies, including long-acting bronchodilators such as umeclidinium bromide—the active ingredient in SEEBRI NEOHALER.

Market Adoption and Prescriber Trends

The adoption curve for SEEBRI NEOHALER aligns with physician familiarity, formulary inclusion, and patient adherence. It benefits from the growing preference for once-daily inhalation therapies that improve compliance. However, competition with other LAMA (long-acting muscarinic antagonists) inhalers, such as tiotropium-based devices, requires innovative positioning and demonstrating distinctions in efficacy or convenience.

Competitive Landscape

SEEBRI NEOHALER faces competition from established brands like Spiriva HandiHaler (Boehringer Ingelheim), umeclidinium/vilanterol combinations (e.g., Anoro Ellipta), and emerging generic options. The competitive environment is intensified by patent expirations and the entry of biosimilars. Strategic alliances and pricing maneuvers are central to maintaining market share.

Regulatory and Reimbursement Environment

Regulatory Approvals and Market Entry

SEEBRI NEOHALER has obtained regulatory approvals across multiple jurisdictions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Market expansion into emerging economies depends on localized regulatory pathways and clinical trial data.

Reimbursement Policies

Reimbursement frameworks significantly influence sales trajectories. In developed markets, inclusion in national formularies and insurance coverage facilitate broader access. Cost-effectiveness analyses favoring SEEBRI NEOHALER can enable favorable reimbursement status, thus expanding its market footprint.

Market Drivers Influencing Financial Trajectory

Innovations in Drug Delivery and Pharmacodynamics

advancements in inhaler technology—such as improved dose accuracy and reduced device misusage—favor SEEBRI NEOHALER’s adoption rate. Confirming superior pharmacodynamics while maintaining safety profiles sustains competitive advantage.

Healthcare Trends Toward Personalized Therapy

The increasing emphasis on personalized COPD management, integrating biomarkers to tailor therapy, could influence SEEBRI NEOHALER’s market positioning, notably if combination therapies or phase-specific treatment protocols emerge.

Economic Factors and Healthcare Spending

Rising healthcare expenditure globally correlates with increased spending on respiratory therapies. Favorable pricing strategies, considering both volume-based discounts and value-based models, can improve revenue streams.

Financial Trajectory and Revenue Forecasts

Current Revenue Status

Considering the drug’s market presence, SEEBRI NEOHALER generated approximately USD 200 million globally in 2022, with steady growth attributable to expanding markets in the U.S., Europe, and Asia-Pacific. This figure indicates a resilient presence amidst competitive challenges.

Projected Growth

Analysts project a CAGR of approximately 4–6% over the next five years, driven by increased COPD prevalence, rising adoption rates in emerging markets, and incremental formulary acceptance.

Potential Market Expansion and Challenges

Emerging markets like China and India, where COPD burdens are high, present lucrative opportunities. However, hurdles such as local regulatory hurdles, price sensitivity, and competition from biosimilars could temper growth projections.

Impact of Patent and Exclusivity Timelines

Patent expiration timelines for key formulations influence future revenue streams. The expiration of primary patents around 2028 could lead to generic entry, pressuring pricing and margins.

Strategic Considerations for Sustained Market Performance

• Product Differentiation: Enhancement of the inhaler device to improve ease of use can gain market share.
• Combination Therapy Development: Collaborations to develop fixed-dose combinations could widen the therapeutic scope.
• Market Diversification: Expanding into new geographic territories with tailored regulatory strategies.
• Cost Management: Optimizing manufacturing efficiencies to sustain profitability amid price competition.

Conclusion

SEEBRI NEOHALER operates in a dynamic, expanding COPD therapeutics market characterized by high unmet needs and evolving healthcare paradigms. Its financial trajectory hinges on sustained innovation, strategic market entry, competitive positioning, and favorable regulatory and reimbursement frameworks. While poised for moderate growth, impending patent cliffs necessitate proactive measures to mitigate revenue decline and capitalize on emerging opportunities.

Key Takeaways

• The global COPD market is expanding, with increasing prevalence supporting continuous demand for inhaled bronchodilators like SEEBRI NEOHALER.
• Market success depends on differentiation via device innovation, clinical efficacy, and strategic pricing.
• Competition from brand and generic products necessitates ongoing innovation and market diversification.
• Patent expiration poses significant revenue risks; proactive lifecycle management is crucial.
• Emerging markets offer growth opportunities, contingent on navigating regulatory and pricing landscapes.

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FAQs

1. What are the primary drivers impacting SEEBRI NEOHALER’s market growth?
The main drivers include rising COPD prevalence, patient preference for once-daily inhalers, technological advancements in inhaler devices, and favorable reimbursement policies in key markets.

2. How does patent expiration influence SEEBRI NEOHALER’s revenues?
Patent expiration around 2028 may lead to generic competition, potentially reducing prices and therapies’ market share, thus impacting revenue unless mitigated through innovation and pipeline development.

3. Which regions present the highest growth potential for SEEBRI NEOHALER?
Emerging markets such as China, India, and Southeast Asia offer substantial growth opportunities driven by increasing COPD burden and expanding healthcare infrastructure.

4. How does SEEBRI NEOHALER compare with competitors like Spiriva HandiHaler?
SEEBRI NEOHALER’s differentiation hinges on device design, dosing convenience, and clinical efficacy. Competitive positioning requires highlighting these aspects alongside strategic pricing.

5. What strategic moves can sustain SEEBRI NEOHALER’s market relevance?
Innovation in delivery devices, development of combination therapies, geographic expansion, and proactive lifecycle management are key strategies to maintain market relevance.

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Sources
[1] Global COPD Drugs Market Report, 2022.