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.

The generic ingredient in LONHALA MAGNAIR KIT is glycopyrrolate. There is one drug master file entry for this compound. Sixty-one 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

US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	104
Patent Applications:	5,035
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			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
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
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	2883583	ELEMENT D'OUVERTURE POUR OUVRIR UNE AMPOULE DANS UN DISPOSITIF DE GENERATION D'AEROSOL COMPRENANT LEDIT ELEMENT D'OUVERTURE (OPENING ELEMENT FOR OPENING AN AMPOULE IN AN AEROSOL GENERATION DEVICE AND AEROSOL GENERATION DEVICE COMPRISING THE OPENING ELEMENT)
China	104619303	打开气雾剂发生装置中的安瓿的打开元件和包括该打开元件的气雾剂发生装置 (Opening element for opening an ampoule in an aerosol generation device and aerosol generation device comprising the opening element)
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)
European Patent Office	2895136	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)
Spain	2740549

Supplementary Protection Certificates for LONHALA MAGNAIR KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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	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

Lonhalа Magnair Kit Market Dynamics, Financial Trajectory, Patent Position and Commercial Outlook

Last updated: August 3, 2026

Lonhala Magnair Kit, Sunovion Pharmaceuticals’ nebulized glycopyrrolate product for maintenance treatment of chronic obstructive pulmonary disease, reached the market as a differentiated but commercially narrow alternative to inhaled long-acting muscarinic antagonists. Sunovion discontinued U.S. commercial availability after December 31, 2023. Product-level revenue was not separately disclosed by Sunovion or parent company Sumitomo Pharma, so the financial trajectory is best assessed through regulatory milestones, product positioning, market competition and the company’s discontinuation decision.[1][2]

What is Lonhala Magnair Kit and how does it work?

Lonhala Magnair contains glycopyrrolate inhalation solution, a long-acting muscarinic antagonist, delivered through the Magnair nebulizer system. The approved dose is 25 mcg administered by oral inhalation twice daily for the long-term maintenance treatment of airflow obstruction in patients with COPD.[3]

The product was designed for patients who have difficulty using conventional handheld inhalers. Its delivery system used PARI’s eFlow technology, a vibrating-membrane nebulizer intended to provide a portable alternative to dry-powder inhalers, metered-dose inhalers and soft-mist inhalers.

Lonhala Magnair was not approved for acute bronchospasm or rescue treatment. Patients requiring immediate symptom relief were expected to use a short-acting bronchodilator.

Product attribute	Lonhala Magnair
Active ingredient	Glycopyrrolate
Drug class	Long-acting muscarinic antagonist
Indication	Maintenance treatment of COPD
FDA application	NDA 208437
Approved dose	25 mcg twice daily
Dosage form	Inhalation solution
Delivery device	Magnair eFlow nebulizer
U.S. approval	December 2017
Commercial status	Discontinued after December 31, 2023
Rescue indication	No
Biosimilar pathway	Not applicable

When did Lonhala Magnair receive FDA approval?

The FDA approved Lonhala Magnair in December 2017 for maintenance treatment of COPD in adults.[3] The approval expanded Sunovion’s respiratory portfolio beyond its established inhaled corticosteroid and bronchodilator products.

The approval depended on the clinical performance of glycopyrrolate and the usability of the Magnair delivery system. The product’s value proposition was therefore tied to both the active ingredient and the device. That combination differentiated Lonhala Magnair from glycopyrrolate products delivered through handheld inhalers.

The FDA label identified common adverse reactions including dyspnea, urinary tract infection and cough. As with other anticholinergic bronchodilators, the labeling addressed risks involving paradoxical bronchospasm, narrow-angle glaucoma and urinary retention.[3]

What market did Lonhala Magnair target?

Lonhala Magnair targeted the maintenance COPD market, particularly patients who could not reliably generate the inspiratory flow required by certain dry-powder inhalers or who had poor coordination with metered-dose inhalers.

Its principal commercial segments were:

• COPD patients with severe airflow limitation.
• Older patients with dexterity, cognition or coordination limitations.
• Patients already using nebulized maintenance therapy.
• Caregivers and clinicians seeking a portable nebulized LAMA.
• Patients who did not achieve adequate control with short-acting nebulized treatment.

The target market was clinically meaningful but commercially constrained. Most COPD maintenance prescriptions were supplied through established inhaler platforms, and many payers preferred products with broader formulary contracts, lower acquisition costs or combination therapy options.

The product also faced a practical adoption barrier: patients needed both the drug solution and the proprietary Magnair device. That created training, replacement and reimbursement requirements that were absent from standard inhalers.

How did Lonhala Magnair compare with competing COPD drugs?

Lonhala Magnair competed in a market dominated by long-acting inhaled bronchodilators and fixed-dose combinations. Relevant alternatives included Spiriva, Tudorza Pressair, Seebri Neohaler, Incruse Ellipta, Yupelri nebulizer solution, Anoro Ellipta, Stiolto Respimat and Trelegy Ellipta.

Product	Active ingredient or class	Delivery system	Commercial positioning
Lonhala Magnair	Glycopyrrolate, LAMA	Portable nebulizer	Nebulized maintenance LAMA
Yupelri	Revefenacin, LAMA	Standard nebulizer	Once-daily nebulized LAMA
Spiriva	Tiotropium, LAMA	HandiHaler or Respimat	Established branded LAMA
Incruse Ellipta	Umeclidinium, LAMA	Dry-powder inhaler	Once-daily handheld LAMA
Anoro Ellipta	Umeclidinium/vilanterol	Dry-powder inhaler	LAMA/LABA combination
Stiolto Respimat	Tiotropium/olodaterol	Soft-mist inhaler	LAMA/LABA combination
Trelegy Ellipta	Fluticasone/umeclidinium/vilanterol	Dry-powder inhaler	Triple therapy

Yupelri was the most direct nebulized competitor because it addressed the same patient segment without requiring the Magnair device platform. Its once-daily dosing also offered a potential adherence advantage over Lonhala Magnair’s twice-daily regimen.

Combination products created a second competitive disadvantage. COPD treatment guidelines and prescribing practice increasingly supported escalation to LAMA/LABA or triple therapy for patients with persistent symptoms or exacerbations. Lonhala Magnair provided a LAMA alone, which limited its role in patients requiring multiple maintenance mechanisms.

What was the financial trajectory of Lonhala Magnair?

Sunovion did not report Lonhala Magnair revenue as a separate line item in public financial disclosures. Sumitomo Pharma reported North American and product-portfolio performance at aggregate levels, preventing a reliable calculation of product sales, gross margin or contribution profit.[1][2]

The commercial trajectory can be divided into four phases:

Period	Commercial phase	Financial interpretation
2017	FDA approval	Initial launch and market-access investment
2018-2019	Early commercialization	Brand-building, payer contracting and device adoption
2020-2021	Competitive expansion	Pressure from established inhalers and nebulized alternatives
2022-2023	Portfolio rationalization	Reduced strategic value and eventual discontinuation
After December 31, 2023	No U.S. commercial supply	U.S. product revenue effectively ended

The product did not become a major disclosed revenue driver for Sumitomo Pharma. The absence of product-level revenue reporting indicates that Lonhala Magnair remained below the company’s threshold for separate financial disclosure or was grouped within a broader respiratory portfolio.

The discontinuation decision likely reflected the combined effect of limited scale, device-related commercial complexity, competition from Yupelri and inhaler-based therapies, and the cost of maintaining a specialized delivery platform. Public company filings did not identify a product-specific revenue target, impairment amount or profitability figure for Lonhala Magnair.[1][2]

Why was Lonhala Magnair discontinued?

Sunovion announced that Lonhala Magnair would no longer be available after December 31, 2023. The discontinuation was a commercial decision rather than an FDA safety withdrawal, based on the available public product information.[4]

The decision had several likely commercial drivers:

1. Narrow patient pool. The product’s strongest rationale applied to patients unable to use conventional inhalers effectively.

2. Device dependence. The Magnair system required separate logistics, training and replacement support.

3. Twice-daily administration. Once-daily nebulized or inhaled alternatives offered simpler maintenance schedules.

4. Combination-therapy competition. LAMA/LABA and triple therapies captured a large share of maintenance escalation.

5. Specialty portfolio prioritization. Sunovion and Sumitomo Pharma had incentives to concentrate resources on products with stronger growth or larger addressable markets.

The discontinuation did not create a conventional generic-entry event. It removed the branded product from commercial distribution and reduced the value of any remaining U.S. market exclusivity.

What patents protected Lonhala Magnair?

Lonhala Magnair’s intellectual-property position involved two distinct layers: the glycopyrrolate inhalation formulation and the Magnair nebulizer delivery system.

The active ingredient, glycopyrrolate, is an established anticholinergic compound and did not provide meaningful new-molecule exclusivity. Protection instead depended on formulation claims, inhalation-solution characteristics, dosing methods, device claims and the combination of drug and delivery system.

Potentially relevant IP categories included:

• Glycopyrrolate inhalation-solution formulations.
• Twice-daily dosing for COPD maintenance.
• Nebulizer configurations and vibrating-membrane delivery.
• Drug-device combinations.
• Manufacturing and packaging of sterile inhalation solutions.
• Method-of-use claims covering long-acting bronchodilation.

FDA Orange Book listing data, rather than the existence of a patent family alone, determines whether a listed patent could support an FDA patent certification for an ANDA. The Orange Book must therefore be distinguished from broader patent databases and device patent portfolios.[5]

Were there Paragraph IV challenges or generic launches?

No publicly documented commercial generic launch for Lonhala Magnair is identified in the cited FDA and company materials. The product’s withdrawal also reduced the incentive for an ANDA sponsor to pursue a direct substitution strategy.

A generic applicant could face technical and regulatory issues beyond active-ingredient equivalence:

• Demonstrating equivalent delivery through the Magnair system.
• Establishing bioequivalence or equivalent clinical performance for a nebulized solution.
• Obtaining access to or designing around the proprietary delivery device.
• Addressing any Orange Book-listed formulation or method patents.
• Securing a commercial supply channel after the reference product’s withdrawal.

A conventional ANDA would be more straightforward for a generic inhalation solution using a widely available nebulizer, but that product would not necessarily be substitutable for Lonhala Magnair under the same device-specific conditions.

No major public Paragraph IV litigation or settlement agreement materially affecting Lonhala Magnair is identified in the cited sources. The absence of a known settlement means there is no public generic-entry date comparable to those established in branded small-molecule patent settlements.

What is the Orange Book status of Lonhala Magnair?

Lonhala Magnair was approved under NDA 208437 and was subject to FDA drug-listing and patent-reporting rules applicable to approved drug products.[3][5]

The practical value of Orange Book protection declined after commercial discontinuation. An Orange Book-listed patent can remain legally relevant after a product is no longer actively marketed, but the commercial incentive to challenge the patent depends on the size of the remaining market and the possibility of an approved reference-product pathway.

The product should be distinguished from a withdrawn NDA. Commercial discontinuation does not automatically mean that FDA approval was withdrawn for safety or efficacy reasons. The regulatory record, drug listing and current FDA status must be reviewed separately from the company’s supply decision.

Does Lonhala Magnair face biosimilar risk?

No. Lonhala Magnair is a small-molecule glycopyrrolate product, not a biologic. Biosimilar provisions under the Public Health Service Act do not apply.

Potential competition would arise through an ANDA, a 505(b)(2) application or a different nebulized glycopyrrolate product. The relevant barriers are formulation equivalence, device compatibility, clinical bridging and patent certification, not biosimilar interchangeability.

What licensing deals affected Lonhala Magnair?

Lonhala Magnair depended on the Magnair delivery platform, which was associated with PARI’s eFlow nebulization technology. The public commercial record does not establish a separately disclosed revenue-sharing arrangement, royalty rate or milestone schedule for Lonhala Magnair.

The product’s economics likely included payments or supply obligations connected with the device platform, but those terms were not reported as a product-specific licensing transaction in the cited Sumitomo Pharma disclosures.[1][2]

What is the commercial outlook after discontinuation?

The U.S. commercial outlook is closed for the discontinued branded product. Revenue from new U.S. Lonhala Magnair prescriptions should be treated as terminated after the announced supply end date, subject only to residual inventory and channel effects.

The broader clinical need remains. Patients who cannot use handheld inhalers still require nebulized maintenance options, but that demand is more likely to flow to Yupelri, generic nebulized bronchodilators, caregiver-administered therapies and other device platforms.

For investors and licensing teams, the product is therefore more relevant as a case study in respiratory drug-device commercialization than as a continuing growth asset. Its remaining strategic value could involve legacy formulation know-how, device engineering, manufacturing knowledge or international rights, but the U.S. branded revenue opportunity is no longer active.

Key Takeaways

• Lonhala Magnair is a nebulized glycopyrrolate LAMA approved for maintenance COPD treatment.
• FDA approval occurred in December 2017 under NDA 208437.
• The product targeted patients who had difficulty using conventional inhalers.
• Its main differentiation was the Magnair eFlow nebulizer, not a novel active ingredient.
• Sunovion discontinued U.S. commercial availability after December 31, 2023.
• Sunovion and Sumitomo Pharma did not separately disclose Lonhala Magnair revenue.
• Direct competition included Yupelri, Spiriva, Incruse Ellipta and LAMA/LABA combination therapies.
• No biosimilar pathway applies because glycopyrrolate is a small molecule.
• No publicly documented major Paragraph IV settlement or commercial generic launch is identified in the cited materials.
• Remaining IP value is concentrated in formulation, device and drug-device combination claims.
• The product’s U.S. revenue trajectory is effectively terminal following discontinuation.

FAQs About Lonhala Magnair Kit

Is Lonhala Magnair still available in the United States?

No. Sunovion stated that Lonhala Magnair would no longer be available after December 31, 2023.[4]

What is the generic name for Lonhala Magnair?

The active ingredient is glycopyrrolate inhalation solution. A generic product would also need to address the delivery-system and regulatory requirements associated with the reference product.

Was Lonhala Magnair a rescue inhaler?

No. It was approved for long-term maintenance treatment of COPD and was not indicated for acute bronchospasm.

What replaced Lonhala Magnair?

Yupelri, revefenacin inhalation solution, is the closest commercially positioned nebulized LAMA alternative. Handheld LAMA products and LAMA/LABA combinations are other treatment alternatives, depending on patient capability and clinical need.

Did Lonhala Magnair generate material revenue for Sumitomo Pharma?

Public filings did not disclose product-level Lonhala Magnair revenue. The product was not reported as a separately material revenue contributor in the cited company disclosures.[1][2]

References

1. Sumitomo Pharma Co., Ltd. (2024). Annual report and financial results materials. https://www.sumitomo-pharma.com/ir/
2. Sunovion Pharmaceuticals Inc. (2023). Corporate and product information. https://www.sunovion.com/
3. U.S. Food and Drug Administration. (2017). Lonhala Magnair prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208437s000lbl.pdf
4. Sunovion Pharmaceuticals Inc. (2023). Lonhala Magnair availability notice. https://www.lonhalamagnair.com/
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/