GenericsWeb, a leader in established pharmaceutical patent searching and analysis, recently published an article based on its proprietary patent intelligence for GlaxoSmithKline's Amerge® and Naramig® (Naratriptan). The article analyses the patent landscape surrounding Naratriptan, 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:
# Unlike the case of Eletriptan marketed by Pfizer, there do not appear to be any specific innovator patents protecting the polymorphic forms for Naratriptan. This suggests that GlaxoSmithKline has missed an opportunity in extending and/or managing the lifecycle of this product, as such it will likely lose significant market share to a number of generic manufacturers upon the expiry of the patent protecting the active ingredient.
# The impending expiry of the US patent protecting the active ingredient of Amerge® in July this year will provide an opportunity to generic companies while the extended term of the European equivalent patent will prevent a launch of a generic version of this product in major European countries until March 2012.
# The term of the equivalent patent in other European countries such as Croatia, Hungary, Ireland, Italy, Poland, Romania and Slovakia is already expired due to no application of SPC or an absence of patent term extension provisions at the time of product launch. This provides a convenient ‘springboard’ for the manufacturers located in these countries who may want to enter the major European and/or the US market.
Naratriptan, a 5-hydroxytryptamine1 (5-HT1) receptor agonist commonly used in the treatment of migraine is marketed by GlaxoSmithKline. It is available as a Naratriptan hydrochloride in film coated tablets.
You can read the full article here.