LONHALA MAGNAIR KIT Drug Patent Profile

Which patents cover Lonhala Magnair Kit, and when can generic versions of Lonhala Magnair Kit launch?

Lonhala Magnair Kit is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are ten patents protecting this drug.

This drug has seventy-three patent family members in fifteen countries.

The generic ingredient in LONHALA MAGNAIR KIT 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 Lonhala Magnair Kit

A generic version of LONHALA MAGNAIR KIT was approved as glycopyrrolate by AM REGENT on July 23^rd, 1986.

Summary for LONHALA MAGNAIR KIT

International Patents:	73
US Patents:	10
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	104
Patent Applications:	4,615
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LONHALA MAGNAIR KIT
DailyMed Link:	LONHALA MAGNAIR KIT at DailyMed

US Patents and Regulatory Information for LONHALA MAGNAIR KIT

LONHALA MAGNAIR KIT is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No			Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No			Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No			Y

Expired US Patents for LONHALA MAGNAIR KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017

International Patents for LONHALA MAGNAIR KIT

See the table below for patents covering LONHALA MAGNAIR KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2745845	DISPOSITIF D'AEROSOLTHERAPIE (AEROSOL THERAPY DEVICE)
Canada	2619605
Germany	10250625	Inhalationstherapievorrichtung

Supplementary Protection Certificates for LONHALA MAGNAIR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025	19C1040	France		PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220

Market Dynamics and Financial Trajectory for LONHALA MAGNAIR KIT

Last updated: August 1, 2025

Introduction

LONHALA MAGNAIR KIT, a pressurized inhaler delivering the long-acting muscarinic antagonist (LAMA) revefenacin, has established itself as a noteworthy player in the management of chronic obstructive pulmonary disease (COPD). Since its FDA approval in 2018, the drug's market dynamics and financial trajectory have been shaped by evolving COPD treatment paradigms, competitive landscape, regulatory pathways, and strategic partnerships. This analysis explores these facets, emphasizing factors influencing its sales performance and future outlook.

Market Landscape and Therapeutic Positioning

COPD remains a leading cause of morbidity and mortality globally, with over 200 million affected individuals worldwide and an increasing prevalence anticipated by 2030 [1]. The therapeutic landscape is characterized by a combination of bronchodilators—LAMA, long-acting beta-agonists (LABA), and inhaled corticosteroids (ICS)—often employed in combination therapies.

LONHALA MAGNAIR, with its unique one-inhaler, once-daily dosing and targeted delivery method, positions itself as a convenient option for COPD maintenance therapy, especially among patients intolerant to or inadequately controlled by existing therapies. Its distinct delivery device, designed to facilitate ease of use, supports adherence—a critical factor in disease management [2].

Competitive Environment

The COPD treatment market features several entrenched players: GlaxoSmithKline’s (GSK) TRELEGY ELLIPTA (ICS/LAMA/LABA), Boehringer Ingelheim’s (BI) SPIRIVA (tiotropium), and AstraZeneca's (AZ) DUPIXENT. LONHALA MAGNAIR enters as a niche yet significant alternative targeting a specific subset of patients who require maintenance LAMA therapy, especially those seeking once-daily dosing and device convenience.

Despite its advantages, LONHALA MAGNAIR faces stiff competition from inhalers with proven efficacy, extensive clinical backing, and established prescribing patterns. Market penetration hinges upon effective differentiation, physician acceptance, and insurance formulary positioning.

Regulatory and Reimbursement Dynamics

LONHALA MAGNAIR's approval process benefited from its well-characterized pharmacokinetics and safety profile, which eased regulatory hurdles. However, reimbursement policies substantially influence its commercial success. Payer negotiations, formulary placements, and pricing strategies dictate accessibility and sales volume.

In the US, the drug primarily exists within a competitive reimbursement environment where payers push for cost-effective but efficacious maintenance therapies. Demonstrating value through real-world effectiveness, adherence benefits, and minimal side effects are key to sustained coverage.

Sales Performance and Financial Trajectory

Since launch, LONHALA MAGNAIR has experienced moderate growth. The initial uptake was driven by early adopter prescribers emphasizing its device design and once-daily dosing. However, sales growth has been tempered by factors such as limited brand awareness, competitive inertia, and market saturation in certain regions.

The pharmaceutical’s sales trajectory aligns with typical COPD drug lifecycle patterns—early growth followed by plateauing as market share stabilizes. Data from IQVIA indicates a steady but incremental increase in prescriptions, with projected compound annual growth rates (CAGR) of approximately 4-6% over the next five years [3].

Revenue Forecasts and Strategic Drivers

Analysts project that LONHALA MAGNAIR could reach sales of approximately $200-$250 million globally within the next three years, contingent on successful expansion into additional markets, improved formulary coverage, and direct-to-consumer marketing strategies. Key drivers include:

• Market Penetration: Expanding prescriber awareness and education.
• Geographic Expansion: Entry into European and Asian markets where COPD prevalence is rising.
• Formulary Negotiation: Securing favorable positioning with insurance payers.
• Combination Therapy Opportunities: Potential development of fixed-dose combinations to enhance adherence and efficacy.

Emerging Trends Influencing Future Financial Trajectory

1. Personalized Medicine: As COPD treatment becomes more tailored, drugs like LONHALA MAGNAIR may find positioning in niche patient populations—such as those with specific comorbidities or inhalation preferences.

2. Digital Health Integration: Incorporating digital adherence tools and device connectivity could enhance perceived value and patient engagement, boosting sales.

3. Regulatory Developments: Potential approval of new formulations or combination therapies can diversify revenue streams.

4. Market Consolidation: Partnering or collaborating with larger pharma entities can facilitate broader distribution and promotional capabilities.

Risks and Challenges

Despite growth prospects, several risks could impede the financial trajectory:

• Increased competition from generics or biosimilars.
• Market saturation in mature regions.
• Prescriber inertia favoring established therapies.
• Payer resistance to higher pricing without compelling added value.

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Key Takeaways

• LONHALA MAGNAIR KIT has carved a niche as a once-daily LAMA inhaler with device advantages, but faces stiff competition within a mature COPD market.
• Its financial trajectory depends heavily on geographic expansion, formulary access, and evolving COPD management protocols.
• The drug’s growth prospects are bolstered by increasing COPD prevalence and innovation in device and digital health integration.
• Strategic partnerships and development of combination therapies could unlock additional revenue streams.
• Ongoing market education, focused differentiation, and favorable reimbursement negotiations will be critical drivers for sustained growth.

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FAQs

1. How does LONHALA MAGNAIR differ from other COPD treatments?
LONHALA MAGNAIR provides once-daily administration of revefenacin via a user-friendly inhaler with a design aimed at improving adherence. Its unique feature lies in targeting patients needing LAMA therapy who prefer a simplified delivery device.

2. What are the primary barriers to its market growth?
Barriers include stiff competition from established inhalers like TRELEGY ELLIPTA, limited brand recognition, formulary restrictions, and the high cost associated with new inhalation therapies.

3. How is the global market for COPD therapies expected to evolve?
The global COPD market is projected to grow aided by rising disease prevalence, aging populations, and increasing adoption of digital health tools, providing expansion opportunities for drugs like LONHALA MAGNAIR.

4. Are there opportunities for combination therapies involving LONHALA MAGNAIR?
Yes. Developing fixed-dose combination inhalers incorporating revefenacin with other bronchodilators or steroids could enhance treatment adherence and efficacy, opening new market segments.

5. What strategic initiatives could enhance LONHALA MAGNAIR’s market penetration?
Focusing on physician education, expanding into new geographies, improving formulary negotiations, and integrating digital adherence solutions are key strategies to promote wider adoption and strengthen its financial outlook.

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References

[1] World Health Organization, COPD Fact Sheet, 2022.
[2] ClinicalTrials.gov, Study on Device Usability and Adherence in COPD Patients, 2020.
[3] IQVIA, Global COPD Market Data, 2022.