Generic Naropin® (Ropivacaine) - Key patent barriers to launch identified by GenericsWeb

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GenericsWeb analyses the patent landscape surrounding Ropivacaine, highlighting the need for comprehensive patent information in the development of launch strategies for generic products to minimise the risk of litigation.

GenericsWeb, a leader in established pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for AstraZeneca's Naropin® (Ropivacaine). The article analyses the patent landscape surrounding Ropivacaine, highlighting the need for comprehensive patent information in the development of launch strategies for generic products to minimise the risk of litigation.

Key findings of the article include:

# Patents filed by AstraZeneca to protect the use of specific concentrations of Ropivacaine in treating pain have been litigated and successfully defended in the US, preventing the launch of a US generic Ropivacaine product until September 2014 or an appeal overturns the original decision. Interestingly, the same patents in Europe will probably not constrain generic competition beyond SPC expiry of the active ingredient patent later this year. Thus it is likely that a generic Ropivacaine product will be on the European market in September 2010 where Teva and Mylan, having granted marketing authorisations, are waiting to launch.

# Key patent barriers protect the use of Ropivacaine for the management of pain. Of particular concern is the patent family which claims the use of low concentrations of Ropivacaine. "The patent members for this family protect only the analgesic indication for Naropin®, allowing generics a possible opportunity to launch products with only the anaesthetic indication." said Colleen Bray, a patent analyst at GenericsWeb.

# Patenting activity relating to Ropivacaine has focused heavily on formulation patents, due to a large number of platform technology patents that relate generally to anaesthetics.

# The patent protecting the active ingredient in Naropin®, Ropivacaine hydrochloride monohydrate, has expired in some territories, however there is considerable variation across Europe, therefore "companies seeking to enter these markets are encouraged to obtain a complete understanding of the landscape surrounding the Naropin® product" comments Miss Bray.

You can read the full article here: http://www.genericsweb.com/druginfocus/Ropivacaine

ABOUT GENERICSWEB - THE SEARCH IS OVER
GenericsWeb, the leader in pharmaceutical patent searching and analysis holds an impeccable track record in providing quality patent information, allowing numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com

PIPELINE DEVELOPER
Pipeline Developer is a professional patent database providing the very best in comprehensive patent information while minimising the risk of wasted developments or legal action. Searched and analysed by highly trained, dedicated staff using sophisticated searching techniques, Pipeline Developer delivers results you can rely on through a convenient online interface. For more information on Pipeline Developer visit http://www.genericsweb.com

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Zac Kardiasmenos
GenericsWeb
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