UTIBRON Drug Patent Profile

Which patents cover Utibron, and what generic alternatives are available?

Utibron is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and forty-eight patent family members in forty countries.

The generic ingredient in UTIBRON is glycopyrrolate; indacaterol maleate. There are seventeen drug master file entries for this compound. Additional details are available on the glycopyrrolate; indacaterol maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Utibron

Utibron 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.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for UTIBRON

International Patents:	148
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	11
Drug Prices:	Drug price information for UTIBRON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UTIBRON
DailyMed Link:	UTIBRON at DailyMed

See drug prices for UTIBRON

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

Constraining patent/regulatory exclusivity:

8,479,730

NDA:

207930

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 UTIBRON

UTIBRON is protected by three 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	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	6,878,721		Y	Y
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	8,182,838		Y
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	8,479,730		Y

Expired US Patents for UTIBRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,048,451
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	9,931,304
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	6,521,260
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,435,567
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	8,303,991

International Patents for UTIBRON

See the table below for patents covering UTIBRON around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	5042426
Canada	2375810	AGONISTES DU RECEPTEUR BETA 2-ADRENERGIQUE (BETA2-ADRENOCEPTOR AGONISTS)
Slovakia	284248
United Kingdom	0011712
Bulgaria	101858

Supplementary Protection Certificates for UTIBRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	SPC/GB10/009	United Kingdom		PRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
1267866	C300651	Netherlands		PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
1267866	2013/014	Ireland		PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866	CA 2014 00020	Denmark		PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
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

UTIBRON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Utibron Neohaler

Introduction

Utibron Neohaler, a combination therapy of indacaterol and glycopyrrolate, is a significant treatment for chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of Utibron Neohaler, particularly focusing on the licensing agreement between Novartis and Sunovion Pharmaceuticals.

Market Dynamics

Licensing Agreement

In December 2016, Novartis announced a licensing agreement with Sunovion Pharmaceuticals Inc. for the US commercial rights to Utibron Neohaler, along with two other COPD treatments, Seebri Neohaler and Arcapta Neohaler. This deal was specific to the US market and did not affect Novartis' global strategy for these products[1][3][4].

Why the Licensing Agreement? Novartis believed that these products would have greater impact in the US when commercialized by a company with an established presence in the COPD field. Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation, emphasized that Novartis would focus on areas in the US where they have strong capabilities and leadership, bringing the greatest value to physicians and patients[3][4].

Global Presence

Outside the US, Novartis maintains a full respiratory presence and portfolio, with Ultibro Breezhaler (indacaterol/glycopyrronium) being the leading therapy in its class. Novartis is committed to building category leadership and meeting the evolving needs of patients with respiratory diseases, including asthma and COPD[1][3][4].

Financial Trajectory

Revenue Impact

The licensing agreement did not immediately impact Novartis' global revenue from these products, as the company continued to manufacture them for Sunovion. However, it allowed Novartis to focus on other areas of its US portfolio, potentially optimizing resource allocation and financial performance[1][3].

Manufacturing and Supply

Novartis continued to manufacture Utibron Neohaler and other licensed products for Sunovion, ensuring a stable supply chain. This arrangement helped maintain the financial stability of the product line while allowing Sunovion to leverage its established presence in the US COPD market[1][3][4].

Market Performance

In markets outside the US, Novartis' respiratory portfolio, including Ultibro Breezhaler, has shown strong performance. Ultibro Breezhaler is the leading therapy in its class, contributing significantly to Novartis' global revenue. This success underscores the financial viability and market acceptance of these products[1][3][4].

Financial Metrics and Performance

Revenue Growth

While the licensing agreement itself did not directly contribute to immediate revenue growth for Novartis in the US, it allowed the company to realign its resources. Globally, Novartis' respiratory portfolio has seen steady growth, driven by strong sales of products like Ultibro Breezhaler[1][3].

Cost and Profitability

The agreement reduced certain operational costs for Novartis, as it no longer had to manage the commercialization of these products in the US. This cost reduction, combined with the continued manufacturing revenue, helped in maintaining profitability. For instance, Novartis avoided the costs associated with marketing and distributing these products in the US, which could have impacted their bottom line[1][3].

Risks and Uncertainties

Regulatory and Market Risks

The financial trajectory of Utibron Neohaler and other licensed products is subject to various risks, including regulatory actions, market dynamics, and healthcare cost containment pressures. These factors can affect the realization of potential benefits from the licensing agreement and the overall performance of the products[1][3].

Competitive Landscape

The COPD market is highly competitive, with multiple players offering various treatments. The success of Utibron Neohaler and other Novartis products depends on their ability to compete effectively against other therapies, which can impact their financial performance[1][3].

Key Takeaways

• Licensing Agreement: Novartis licensed the US commercial rights for Utibron Neohaler to Sunovion, focusing on areas where they have strong capabilities.
• Global Presence: Novartis maintains a strong global respiratory portfolio, with Ultibro Breezhaler leading in its class outside the US.
• Financial Stability: The agreement ensured stable manufacturing revenue and allowed Novartis to realign resources.
• Market Performance: Strong global sales of Novartis' respiratory products, including Ultibro Breezhaler.
• Risks and Uncertainties: Subject to regulatory, market, and competitive risks.

FAQs

Q: What was the nature of the licensing agreement between Novartis and Sunovion for Utibron Neohaler? A: Novartis licensed the US commercial rights for Utibron Neohaler, along with Seebri Neohaler and Arcapta Neohaler, to Sunovion Pharmaceuticals Inc., while continuing to manufacture these products.

Q: How did this agreement affect Novartis' global strategy? A: The agreement was specific to the US market and did not affect Novartis' global strategy for these products. Novartis continued to maintain a full respiratory presence and portfolio outside the US.

Q: What are the key financial implications of this agreement? A: The agreement allowed Novartis to reduce operational costs associated with commercializing these products in the US and focus on other areas of its portfolio, potentially optimizing resource allocation and financial performance.

Q: What are the risks associated with the financial trajectory of Utibron Neohaler? A: The financial trajectory is subject to regulatory actions, market dynamics, healthcare cost containment pressures, and competitive landscape risks.

Q: How has the global market responded to Novartis' respiratory portfolio, including Ultibro Breezhaler? A: The global market has responded positively, with Ultibro Breezhaler being the leading therapy in its class outside the US, contributing significantly to Novartis' global revenue.

Sources

1. Novartis Press Release: "Novartis out-licenses three COPD products in the US"[1]
2. Globenewswire: "2019 Preliminary Results - Vectura reports"[2]
3. PR Newswire: "Novartis out-licenses three COPD products in the US"[3]
4. Drug Discovery Trends: "Novartis Out-Licenses Three COPD Products in the US"[4]