More to Veterinary Anthelmintic ProHeart® than Green Book Indicates
Summary
Analysis of the GenericsWeb Pipeline Patent Intelligence for Wyeth’s top selling veterinary anthelmintic ProHeart® (Moxidectin) shows that generic manufacturers should be wary of relying upon the US FDA Green Book for their critical patent expiry information.Analysis of the GenericsWeb Pipeline Patent Intelligence for Wyeth’s top selling veterinary anthelmintic ProHeart® (Moxidectin) shows that generic manufacturers should be wary of relying upon the US FDA Green Book for their critical patent expiry information.
The US FDA Green Book lists five critical US patents, of which three relate to formulations, one to a combination of actives, and, most significantly, only one to protection of the Moxidectin molecule. However, the Pipeline Developer report for Moxidectin compiled by GenericsWeb indicates that there are actually three patent families that disclose the active ingredient per se, including one patent family of particular significance that is not disclosed in the Green Book.
Generic manufacturers relying upon the US FDA Green Book for critical patent expiry information will be expecting Moxidectin to come “off patent” in 2007 in most territories. As such, they would be surprised to learn that the additional patent family identified by GenericsWeb protects ProHeart® from generic competition in the until two months after the Green Book listed patent. Furthermore, those manufacturers using the Green Book as a guide to the European patent situation will not be aware that an additional 2 years protection of the product is afforded in major European territories by virtue of SPC extensions.
“These anomalies in patent reference lists outline the dangers in taking shortcuts to determine the patent status of products with a view to launching generic equivalents.” said Leighton Howard, Managing Director of GenericsWeb.
The GenericsWeb Pipeline Developer report for Moxidectin identifies over 75 patent families relevant to development of a veterinary generic equivalent of ProHeart®, covering molecular forms, preparative processes, formulations, and indicated uses and administration. “The importance of a comprehensive patent search can never be underestimated,” continued Mr Howard, “given that only five patent families are listed in the Green Book, generic manufacturers are exposing themselves to large risks if they do not analyse the results of comprehensive patent searching”.
The extent of patent protection for the ProHeart® product demonstrates the firm resolve of innovator companies to protect their revenues wherever possible in this market, and the corresponding determination of generic competition in trying to overcome these obstacles.
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 customers contact Sweta Lee at s.lee@genericsweb.com tel. +44 870 879 0081.
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