ARCAPTA NEOHALER Drug Patent Profile

When do Arcapta Neohaler patents expire, and what generic alternatives are available?

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

This drug has eighty-six patent family members in thirty-nine countries.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. Additional details are available on the indacaterol maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Arcapta Neohaler

Arcapta Neohaler was eligible for patent challenges on July 1, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ARCAPTA NEOHALER

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Patent Applications:	152
Drug Prices:	Drug price information for ARCAPTA NEOHALER
DailyMed Link:	ARCAPTA NEOHALER at DailyMed

See drug prices for ARCAPTA NEOHALER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ARCAPTA NEOHALER

Constraining patent/regulatory exclusivity:

8,479,730

NDA:

022383

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ARCAPTA NEOHALER

ARCAPTA NEOHALER is protected by two US patents.

This potential generic entry date is based on patent 8,479,730.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	6,878,721		Y	Y
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No	8,479,730		Y

Expired US Patents for ARCAPTA NEOHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,067,437
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,796,307
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011	8,658,673

International Patents for ARCAPTA NEOHALER

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

Country	Patent Number	Title	Estimated Expiration
Canada	2563573	DISPOSITIF D'INHALATION (INHALER DEVICE)
Czech Republic	302403	Agonisté beta-2-adrenoceptoru (Beta 2-adrenoreceptor agonists)
Japan	2007536962

Supplementary Protection Certificates for ARCAPTA NEOHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
1183240	SPC009/2010	Ireland		SPC009/2010: 20100813, EXPIRES: 20241129

ARCAPTA NEOHALER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Arcapta Neohaler

Introduction

Arcapta Neohaler, developed by Novartis, is a significant treatment option for patients with chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of Arcapta Neohaler, highlighting its impact, regulatory approvals, and commercial performance.

Market Need and Prevalence of COPD

COPD is a progressive and life-threatening lung disease affecting over 14 million Americans and is a major cause of long-term disability[1].

• The prevalence of COPD creates a substantial market need for effective treatments, driving demand for medications like Arcapta Neohaler.

Regulatory Approvals and Indications

• Arcapta Neohaler (indacaterol inhalation powder) was approved by the FDA in March 2012 for the long-term maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD, including chronic bronchitis and/or emphysema[1].
• It is the only once-daily, 24-hour long-acting beta2-agonist (LABA) approved in the US for this indication[1].

Clinical Efficacy

• Clinical trials demonstrated significant improvements in lung function (FEV1) lasting 24 hours, with improvements seen as early as five minutes after the first dose[1].
• Arcapta Neohaler also showed improvements in health-related quality of life, as measured by the St George's Respiratory Questionnaire (SGRQ)[1].

Safety and Tolerability

• The safety and tolerability of Arcapta Neohaler were assessed in a clinical program involving over 5,400 COPD patients. Adverse reactions were reported by 48% of patients treated with Arcapta Neohaler, with common serious adverse reactions including COPD exacerbation, pneumonia, angina pectoris, and atrial fibrillation[1].

Commercial Performance

• Following its approval, Arcapta Neohaler was launched in the US market, marking a significant milestone in Novartis's respiratory portfolio[1].
• The drug was initially commercialized by Novartis but later out-licensed to Sunovion Pharmaceuticals Inc. in December 2016 for US commercial rights. Novartis continued to manufacture the product[4].

Financial Impact

• The launch of Arcapta Neohaler contributed to Novartis's strong financial performance, particularly in the respiratory segment. Novartis's overall net sales achieved USD 58.6 billion, with significant investments in R&D[1].
• Although specific financial figures for Arcapta Neohaler are not detailed, its inclusion in Novartis's respiratory portfolio, which also includes other successful COPD treatments like Utibron Neohaler and Seebri Neohaler, indicates a substantial revenue stream[4].

Market Dynamics

• Competitive Landscape: The COPD treatment market is competitive, with several long-acting bronchodilators available. However, Arcapta Neohaler's once-daily dosing and 24-hour efficacy set it apart[1].
• Growth Drivers: The rising prevalence of COPD and the need for effective, long-term treatments drive the market growth. Regulatory approvals and positive clinical outcomes further support the drug's market position[1][3].
• Challenges: The market faces challenges such as pricing pressures, regulatory uncertainties, and competition from other respiratory treatments. These factors can impact the financial trajectory and market share of Arcapta Neohaler[4].

Global Reach

• Arcapta Neohaler, initially approved in the European Union under the brand name Onbrez Breezhaler in November 2009, is now approved in over 80 countries and available in more than 30 countries[1].

Licensing and Partnerships

• The licensing agreement with Sunovion Pharmaceuticals Inc. for US commercial rights highlights strategic partnerships in the pharmaceutical industry. Such agreements can enhance market reach and financial performance by leveraging the strengths of different companies[4].

Future Outlook

• The COPD treatment market is expected to continue growing, driven by the increasing prevalence of the disease and the need for innovative treatments. Arcapta Neohaler, with its unique once-daily dosing and proven efficacy, is well-positioned to remain a significant player in this market[3].

Key Takeaways

• Arcapta Neohaler is a novel once-daily LABA approved for the maintenance treatment of COPD.
• It has demonstrated significant improvements in lung function and health-related quality of life.
• The drug's commercial performance has contributed to Novartis's strong financials in the respiratory segment.
• Market dynamics are driven by the rising prevalence of COPD and the need for effective treatments, despite challenges such as competition and pricing pressures.

FAQs

Q: What is Arcapta Neohaler used for? A: Arcapta Neohaler is used for the long-term maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema[1].

Q: How often is Arcapta Neohaler administered? A: Arcapta Neohaler is administered once daily, providing 24-hour bronchodilation[1].

Q: What are the key clinical benefits of Arcapta Neohaler? A: Arcapta Neohaler improves lung function (FEV1) lasting 24 hours, with improvements seen as early as five minutes after the first dose, and also improves health-related quality of life[1].

Q: Who currently holds the US commercial rights for Arcapta Neohaler? A: The US commercial rights for Arcapta Neohaler are held by Sunovion Pharmaceuticals Inc., following a licensing agreement with Novartis in December 2016[4].

Q: How widespread is Arcapta Neohaler globally? A: Arcapta Neohaler is approved in over 80 countries and available in more than 30 countries worldwide[1].

Sources

1. Novartis Pharmaceuticals Corporation. "Novartis launches Arcapta™ Neohaler™, a novel once-daily bronchodilator for chronic obstructive pulmonary disease." PR Newswire, March 19, 2012.
2. Sumitomo Pharma. "Innovation today, healthier tomorrows - Sumitomo Pharma Annual Report 2017."
3. BioSpace. "U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033."
4. Novartis. "Novartis out-licenses three COPD products in the US." December 21, 2016.
5. FiercePharma. "Novartis delivered solid performance in the first quarter, with eight key regulatory approvals and all divisions contributing to growth."