Levitra® - Opportunity for Proactive Generic Companies?

SYDNEY, N.S.W., 2 Mar 2007 – The recently released GenericsWeb Pipeline Developer patent report for Levitra® (Vardenafil) highlights the importance of high quality patent information when considering development of generic equivalents in the early stages of a product’s lifecycle.

Levitra®, launched by Bayer in 2003, is closely related to Pfizer’s blockbuster product Viagra® (Sildenafil), and is indicated for the treatment of erectile dysfunction. According to Bayer, sales of Levitra® were €260 million in 2005. Levitra® contains Vardenafil hydrochloride in the form of a trihydrate and is sold as oral film-coated tablets.

Proactive generic companies seeking to circumvent Bayer’s patent position will be encouraged by the fact that of the seventy two patent families identified as being relevant to generic competition, only two protect the molecule – one claiming the molecule per se and the other covering a method for its preparation.

At this stage of the product’s life-cycle only one patent protecting the Vardenafil molecule per se is listed in the Orange Book, however, analysis of the Pipeline Developer report by patent information experts at GenericsWeb reveals a number of patent families that could further delay generic versions of this drug, yet are not listed in the Orange Book. Of particular interest is Bayer’s pending patent covering the preparation of solid dosage forms of Vardenafil hydrochloride in the trihydrate form that is expected to expire in 2023 if granted by patent offices across the globe. Risks are also evident in the identification of Bayer’s filed patents claiming rapidly disintegrating oral formulations, which could protect a significant share of the product’s revenues from generic entry, should alternative formulations be approved later in the drug’s lifecycle.

“Life Cycle Management (LCM) strategies of innovator companies are often designed to introduce barriers to generic entry” commented Leighton Howard, Managing Director of GenericsWeb. “It is therefore critical to understand the full patent landscape of the current product and any potential line extensions when devising strategies for generic entry” he continued.

Although expiry of the ‘molecule’ patent for Levitra® is more than ten years away, generic companies are already showing signs of interest in this molecule by filing their own patent protection for methods to circumvent key innovator patents. Mr. Howard also points out that “this is a clear signal that the generics industry is responding to innovator LCM strategies and the increased competition in the generic field by comprehensively analysing patent protection earlier in the product’s life cycle.”

About GenericsWeb

GenericsWeb Pipeline Patent Intelligence provides unrivalled patent knowledge required to navigate your generic drug development with confidence, all at the click of a button. Established in 1999, GenericsWeb has customers in over 30 countries including legal practices, government departments, consultants and generic manufacturers. For further information about GenericsWeb Pipeline Patent Intelligence, contact Jesse Tale at j.tale@genericsweb.com tel. +61-2-98186111 or, for European and U.S. customers contact Sweta Lee at s.lee@genericsweb.com tel. +44 870 879 0081.

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