|By PR Newswire||
|December 12, 2012 01:12 PM EST||
NEW YORK, Dec. 12, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Inhalation & Nasal Spray Generic Drugs 2012
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
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?
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.
Contact Nicolas: [email protected]
Intl: +1 805-652-2626
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Sep. 25, 2016 10:45 PM EDT Reads: 1,812
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
Sep. 25, 2016 10:45 PM EDT Reads: 1,578
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Sep. 25, 2016 10:45 PM EDT Reads: 4,401
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Sep. 25, 2016 10:00 PM EDT Reads: 1,694
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
Sep. 25, 2016 09:30 PM EDT Reads: 2,486
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
Sep. 25, 2016 09:00 PM EDT Reads: 918
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
Sep. 25, 2016 07:30 PM EDT Reads: 2,601
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Sep. 25, 2016 07:15 PM EDT Reads: 1,239
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Sep. 25, 2016 05:30 PM EDT Reads: 1,559
SYS-CON Events announced today that Secure Channels will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
Sep. 25, 2016 05:15 PM EDT Reads: 1,530
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Sep. 25, 2016 05:00 PM EDT Reads: 1,771
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Sep. 25, 2016 03:00 PM EDT Reads: 1,591
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
Sep. 25, 2016 02:30 PM EDT Reads: 1,528
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
Sep. 25, 2016 02:00 PM EDT Reads: 1,523
SYS-CON Events announced today the Kubernetes and Google Container Engine Workshop, being held November 3, 2016, in conjunction with @DevOpsSummit at 19th Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA. This workshop led by Sebastian Scheele introduces participants to Kubernetes and Google Container Engine (GKE). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, students learn the key concepts and practices for deploying and maintainin...
Sep. 25, 2016 02:00 PM EDT Reads: 2,623