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-two 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. Sixty 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:	72
US Patents:	10
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	26
Patent Applications:	14
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	10,940,110		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,604,018		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	7,931,212		Y
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017		DISCN	Yes	No	9,168,556		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	8,511,581
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	7,458,372
Sumitomo Pharma Am	LONHALA MAGNAIR KIT	glycopyrrolate	SOLUTION;INHALATION	208437-001	Dec 5, 2017	7,316,067

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
Japan	4787307
Australia	2009326049	Aerosol therapy device
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)
Australia	2006281561	Inhalation therapy device comprising an ampoule for holding a drug to be atomized

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
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	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

Introduction to LONHALA MAGNAIR

LONHALA MAGNAIR, developed by Sunovion Pharmaceuticals Inc., is a significant advancement in the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema[1][4].

Market Need and Target Population

COPD is a prevalent and serious respiratory disease affecting millions of Americans, with approximately 15.7 million adults in the U.S. reporting a diagnosis. The disease is characterized by persistent respiratory symptoms and airflow limitation, often caused by significant exposure to toxic particles or gases[4].

Approval and Launch

LONHALA MAGNAIR received FDA approval in December 2017 and became available in U.S. pharmacies in early 2018. This approval marked a significant milestone in COPD treatment, offering patients a nebulized option that combines the efficacy of a proven medication with the convenience of a unique handheld nebulizer[1][4].

Clinical Efficacy and Safety

Clinical studies demonstrated that LONHALA MAGNAIR showed statistically significant and clinically important changes from baseline in forced exhalation (trough forced expiratory volume in one second, FEV1) at Week 12 versus placebo. The medication was generally well-tolerated, with common side effects including dyspnea and urinary tract infections[1][3].

Market Positioning

LONHALA MAGNAIR fills a critical gap in COPD treatment by offering a nebulized delivery option, which is particularly beneficial for patients who may have difficulties using handheld devices. This nebulizer, based on eFlow® technology developed by PARI Pharma GmbH, is virtually silent, portable, and delivers the medication in two to three minutes, allowing patients to breathe normally during use[1][4].

Financial Performance and Revenue

The financial performance of LONHALA MAGNAIR has been part of Sunovion's broader portfolio of COPD therapies. While specific revenue figures for LONHALA MAGNAIR alone are not detailed in the available sources, the drug's introduction was expected to contribute to Sunovion's revenue in the respiratory segment.

However, recent financial reports indicate that the sales of LONHALA MAGNAIR, along with another product KYNMOBI, have been discontinued. This decision is reflected in Sumitomo Pharma's financial results, which show a decline in revenue and profitability in the relevant segments[2][5].

Discontinuation of Sales

In 2023, it was announced that the sales of LONHALA MAGNAIR would be discontinued, along with KYNMOBI. This decision likely impacts the financial trajectory of the product, as it will no longer contribute to the company's revenue stream. The reasons behind this discontinuation are not explicitly stated but could be related to market dynamics, competition, or other strategic considerations[2].

Impact on Sunovion and Sumitomo Pharma

The discontinuation of LONHALA MAGNAIR sales will affect Sunovion's and Sumitomo Pharma's financial performance. Sumitomo Pharma's consolidated financial results for the year ended March 31, 2023, show a decline in core operating profit and revenue, partly due to the discontinuation of these products[2][5].

Competitive Landscape

The COPD treatment market is competitive, with various therapies available, including handheld inhalers and other nebulized options. LONHALA MAGNAIR's unique selling point was its nebulized delivery system, which appealed to a specific segment of patients. However, the discontinuation of its sales suggests that it may not have achieved the expected market penetration or profitability[1][4].

Patient and Healthcare Provider Perspective

For patients, the discontinuation of LONHALA MAGNAIR means they will need to explore alternative treatment options. Healthcare providers will also need to adjust their treatment protocols, potentially shifting to other available therapies that meet their patients' needs.

Future Outlook

The future outlook for LONHALA MAGNAIR is clear: it will no longer be a part of the treatment options for COPD patients. Sunovion and Sumitomo Pharma will likely focus on other products within their portfolios to drive revenue and growth.

Key Takeaways

• First Nebulized LAMA: LONHALA MAGNAIR was the first nebulized long-acting muscarinic antagonist approved for COPD treatment in the U.S.
• Clinical Efficacy: It demonstrated significant improvements in FEV1 and was generally well-tolerated.
• Market Positioning: It filled a gap for patients preferring nebulized delivery over handheld devices.
• Discontinuation: Sales of LONHALA MAGNAIR have been discontinued, impacting the financial performance of Sunovion and Sumitomo Pharma.
• Competitive Landscape: The COPD market remains competitive, with various treatment options available.

FAQs

Q: What is LONHALA MAGNAIR used for? A: LONHALA MAGNAIR is used for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Q: How is LONHALA MAGNAIR administered? A: LONHALA MAGNAIR is administered via inhalation using the MAGNAIR Nebulizer System, which delivers the medication in two to three minutes.

Q: Why was LONHALA MAGNAIR discontinued? A: The specific reasons for the discontinuation of LONHALA MAGNAIR sales are not detailed, but it is likely due to strategic or financial considerations.

Q: What are the common side effects of LONHALA MAGNAIR? A: Common side effects include dyspnea and urinary tract infections.

Q: How does LONHALA MAGNAIR compare to other COPD treatments? A: LONHALA MAGNAIR offered a unique nebulized delivery option, which was beneficial for patients who had difficulties using handheld devices.

Cited Sources

1. Sunovion Announces Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution Now Available in the U.S. for the Treatment of COPD - Business Wire
2. Investors Meeting Presentation for FY2022 - Sumitomo Pharma
3. LONHALA MAGNAIR (glycopyrrolate) inhalation solution, for oral inhalation - FDA
4. Sunovion Receives FDA Approval for Lonhala™ Magnair™ Inhalation Solution to Treat COPD - Business Wire
5. Consolidated Financial Results for the Year Ended March 31, 2023 - Sumitomo Pharma

Last updated: 2024-12-18