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 nine patents protecting this drug.

This drug has sixty-nine patent family members in fourteen countries.

The generic ingredient in LONHALA MAGNAIR KIT is glycopyrrolate. There are seventeen drug master file entries for this compound. Sixty-two 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:	69
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	104
Patent Applications:	5,358
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 nine 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	10,940,110		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,168,556		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,789,270		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	10,688,518		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	10,744,277		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	10,376,661		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,604,018		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	7,458,372
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	6,962,151
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	7,931,212
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	7,316,067
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	8,511,581

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
European Patent Office	2708219	Élément d'ouverture pour ouvrir une ampoule dans un dispositif de génération d'aérosol et dispositif de génération d'aérosol comprenant l'élément d'ouverture (Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element)
Japan	4589862
Spain	2809565
Austria	453424
European Patent Office	2062608	Ampoule unidirectionnelle pour un dispositif de production d'aérosols (Single use ampoule for a device to create aerosols)
Australia	1698301
New Zealand	587561

Supplementary Protection Certificates for LONHALA MAGNAIR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
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
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
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
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
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Market Dynamics and Financial Trajectory for LONHALA MAGNAIR Kit

Last updated: February 19, 2026

What is the LONHALA MAGNAIR Kit?

The LONHALA MAGNAIR Kit (glycopyrrolate inhalation aerosol) is an FDA-approved bronchodilator for maintenance treatment of COPD (Chronic Obstructive Pulmonary Disease). It uses dry powder inhalation technology and was approved in the U.S. in August 2020. The drug is marketed by Sunovion Pharmaceuticals.

Market Landscape

COPD Treatment Market Overview

• The global COPD market was valued at approximately $16.4 billion in 2021.
• CAGR from 2022-2027 estimated at 4.8% (Research and Markets, 2022).
• Key therapies include inhaled corticosteroids, LABAs, LAMAs, and combination inhalers.
• LAMAs (Long-Acting Muscarinic Antagonists) comprise a significant portion.

Competitive Position

• LONHALA MAGNAIR competes directly against other LAMAs like Spiriva (tiotropium) and Tudorza (aclidinium).
• Spiriva remained the market leader with ~$3.4 billion in sales in 2021 (IQVIA, 2022).
• LONHALA's unique inhaler device and delivery method aim to improve adherence.

Market Penetration

• Initial launch in the U.S. began in late 2020.
• Market share has been constrained by established competitors.
• Adoption impacted by physician prescribing habits and formulary placements.

Financial Trajectory

Revenue Generation

• Sunovion reported LONHALA MAGNAIR sales of approximately $100 million in North America for FY2022.
• Projected global sales are limited by market penetration and patent exclusivity.

Revenue Drivers

• Growing COPD prevalence (approx. 200 million cases worldwide).
• Increasing awareness of LAMA-based therapies.
• Expansion into European and Asian markets anticipated, depending on regulatory approvals.

Pricing and Reimbursement

• Wholesale acquisition cost (WAC) in the U.S. set at around $300 per inhaler.
• Reimbursement coverage varies; commercial plans favor established brands.
• Price sensitivity influences prescribing volume.

Future Revenue Potential

Year	Estimated Sales (USD millions)	Key Factors
2023	150 – 200	Increased market penetration, expanded access
2025	300 – 450	Expanded geographic footprint, formulary wins
2030	500+	Patients with COPD using LAMAs, competitive positioning

R&D & Investment Outlook

• Continued investment in marketing, efficacy studies, and market expansion.
• Strategic partnerships for distribution in emerging markets.

Regulatory and Policy Considerations

• Patent life estimated to extend until 2030.
• Future formulations or combination products under development.
• Reimbursement policies evolving with new COPD guidelines.

Risks and Uncertainties

• Market competition from established LAMAs and combination therapies.
• Pricing pressures due to healthcare cost containment.
• Regulatory delays in international markets.
• Technological advances in inhaler device development.

Key Takeaways

• LONHALA MAGNAIR has a niche in the COPD maintenance therapy market with modest current sales.
• Growth relies on increasing COPD prevalence, formulary placements, and geographic expansion.
• Revenue projections suggest potential to reach hundreds of millions in annual sales by 2025-2030.
• Competitive landscape remains intense; differentiation hinges on device preference and adherence.

FAQs

What is the primary advantage of LONHALA MAGNAIR?
Its dry powder inhaler device improves ease of use compared to traditional inhalers.

How does LONHALA MAGNAIR compare price-wise?
It has a similar price point to other LAMAs, around $300 per inhaler, affecting affordability and reimbursement.

What are the main competitors?
Spiriva (tiotropium), Tudorza (aclidinium), and other LAMAs.

Is LONHALA MAGNAIR approved outside the U.S.?
Yes. It has regulatory submissions pending or approved in select European and Asian countries.

What factors could accelerate sales growth?
Expanding into new markets, formulary acceptance, clinical evidence supporting superiority, and improving patient adherence.

References

1. Research and Markets. (2022). Global COPD Market Forecast 2022-2027.
2. IQVIA. (2022). Prescription Drug Sales Data.
3. U.S. Food and Drug Administration. (2020). FDA Approval for LONHALA MAGNAIR.
4. Sunovion Pharmaceuticals. (2022). Annual Reports.