Click here to close now.


News Feed Item

Inhalation & Nasal Spray Generic Drugs 2012

NEW YORK, Dec. 12, 2012  /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Inhalation & Nasal Spray Generic Drugs 2012 .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Generic_Drug

It is no surprise then, that such high revenue originator drugs are attracting interest from prospective generic competitors. Unlike the oral generics market, however, where numerous companies typically compete for a revenue share, relatively few companies have the technology and expertise to compete in the market for generic inhalation and nasal spray products. But for those that are successful, there are significant revenue opportunities.

Overcoming the delivery challenge
While it is possible for companies to develop bioequivalent generic versions of nasal spray products, significant barriers remain to gaining entry into the more lucrative asthma/COPD market. The few generic inhalable products currently approved by the FDA in this therapy area are solutions, generally for delivery via a nebuliser. This is
partly due to developments in the delivery devices, following the phasing out of CFCs in metered dose inhalers (MDIs) in favour of devices that use the more ozone friendly
hydrofluoroalkane (HFA).

Developing a hand-held generic inhaler is no easy task. The bioavailability of the drug in the airway relies on a combination of the drug and the delivery device. To date, companies have been unable to gain marketing approval for bioequivalent generics in the US via the ANDA route. Some generics have been approved in the EU, but these are generally branded products that use proprietary inhalation devices and are, therefore, not pure generics and unlikely to be interchangeable at the pharmacy.

Key questions answered:

What delivery solutions have been found?
Which are the products to watch?
Who's making the running in this sector?

The answer to these and thousands of other key business questions can be found in this new market research study from Espicom. Essential reading for pharma executives, those in the generic field and the commercial community, this 128-page fact-filled report provides a complete and comprehensive review of the issues, trends, products and companies that are shaping the global market in this sector.

Development of generic alternatives in this sector will require some inspired thinking. Maybe not a generic approach at all?

Patent issues
The generic market is undergoing radical restructuring, with much rationalisation of the corporate landscape. In such a competitive environment, companies are now seeking not just new opportunities, but opportunities which combine good profit levels and a degree of product novelty ? both of which are available in the inhalation and nasal spray market.

Side stepping the bioequivalence problem
A few companies have avoided this problem by gaining approval for branded products that use proprietary inhalation devices. Among these are Teva, which has two successful branded asthma inhalers, Proair (salbutamol) and Qvar (beclomethasone dipropionate); and Orion, with its Easyhaler DPI. In October 2011, Teva became the first company to launch a generic salmeterol xinafoate 25mcg pMDI in the UK, following approval by the MHRA in April 2011. The UK marketing authorisation holder for the product, which is branded Neovent/Sereflo, is Neolab Ltd, a UK-based pharmaceutical development company. GSK has been quick to point out that Neovent is a branded product that is not identical to Serevent and, therefore, not an interchangeable generic. This is clearly Teva's approach: its beclomethasone dipropionate HFA nasal aerosol for the treatment of SAR will not be a generic and an NDA was submitted in May 2011 to the FDA.

Gearing up for Seretide/Advair?
Undoubtedly the biggest prize for generic manufacturers will be the current market leader: GSK's Seretide/Advair, which achieved revenue of US$8,247 million in 2011 –
nearly twice the value of its nearest competitor. GSK has US patents for Advair with expiry dates up to July 2025, although the combination patent expired in 2010. In Europe the UK patent has been revoked, but Seretide is protected by Supplementary Protection Certification in other countries until 2013.

At least two generic versions of Seretide/Advair are currently in development. Sandoz and Vectura are jointly developing VR315, a combination product that is widely thought to be generic Seretide/Advair. Sandoz currently has development and commercialisation rights in Europe and other markets, excluding the US. Vectura licensed the US rights to this product to an undisclosed pharmaceutical company in August 2011. Mylan is developing a generic fluticasone+salmeterol combination product, utilising Pfizer's dry powder inhaler delivery platform, following an agreement between the companies in 2011. Mylan is targeting a launch of its generic in Europe in 2015, followed by the US in 2016.

To order this report:
Generic_Drug Industry:
Inhalation & Nasal Spray Generic Drugs 2012

Contact Nicolas: [email protected]
US: (805)-652-2626
Intl: +1 805-652-2626


SOURCE Reportlinker

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Docker is hot. However, as Docker container use spreads into more mature production pipelines, there can be issues about control of Docker images to ensure they are production-ready. Is a promotion-based model appropriate to control and track the flow of Docker images from development to production? In his session at DevOps Summit, Fred Simon, Co-founder and Chief Architect of JFrog, will demonstrate how to implement a promotion model for Docker images using a binary repository, and then show h...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively.
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Achim Weiss is Chief Executive Officer and co-founder of ProfitBricks. In 1995, he broke off his studies to co-found the web hosting company "Schlund+Partner." The company "Schlund+Partner" later became the 1&1 web hosting product line. From 1995 to 2008, he was the technical director for several important projects: the largest web hosting platform in the world, the second largest DSL platform, a video on-demand delivery network, the largest eMail backend in Europe, and a universal billing syste...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. Migration to cloud shifts computing resources from your data center, which can yield significant advantages provided that the cloud vendor an offer enterprise-grade quality for your application.
The IoT is upon us, but today’s databases, built on 30-year-old math, require multiple platforms to create a single solution. Data demands of the IoT require Big Data systems that can handle ingest, transactions and analytics concurrently adapting to varied situations as they occur, with speed at scale. In his session at @ThingsExpo, Chad Jones, chief strategy officer at Deep Information Sciences, will look differently at IoT data so enterprises can fully leverage their IoT potential. He’ll sha...
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi's VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driv...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...
As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ability. Many are unable to effectively engage and inspire, creating forward momentum in the direction of desired change. Renowned for its approach to leadership and emphasis on their people, organizations increasingly look to our military for insight into these challenges.
Nowadays, a large number of sensors and devices are connected to the network. Leading-edge IoT technologies integrate various types of sensor data to create a new value for several business decision scenarios. The transparent cloud is a model of a new IoT emergence service platform. Many service providers store and access various types of sensor data in order to create and find out new business values by integrating such data.
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction....
Containers are changing the security landscape for software development and deployment. As with any security solutions, security approaches that work for developers, operations personnel and security professionals is a requirement. In his session at @DevOpsSummit, Kevin Gilpin, CTO and Co-Founder of Conjur, will discuss various security considerations for container-based infrastructure and related DevOps workflows.