Sep 21 2006
Court cases regarding patent infringement effectively slow generics in coming to market, however US lawmakers and FDA continue to make it easier for generic drugs to gain approval (Cutting Edge Information).
Pfizer faces a litany of patent cases regarding its Lipitor patent, which is set to expire in 2011. Ranbaxy wants to push its generic equivalent of Lipitor to market before Lipitor's patent expiration. With recent regulatory changes, branded companies can only delay generic product launch once under each patent in question. Pfizer's task ahead entails preventing generic competition from taking away Lipitor's market share while it remains under patent exclusivity.
The District Court of The Hague in the Netherlands ruled to uphold the patent for the basic ingredient in Lipitor until its 2011 expiration. Although the Dutch decision does not affect Lipitor patents in the US, Pfizer hopes that cases in the United States will be ruled in favor of protecting Lipitor's market exclusivity as well.
"Innovative drug companies need to utilize market research to act early in preparing their brands which are threatened by generic competition," said Eric Bolesh, project team leader at Cutting Edge Information. "Generic competitors continue to make gains on branded companies in terms of ease in entering the market."
Cutting Edge Information's report "Combating Generics: Pharmaceutical Brand Defense for 2007" can assist companies in finding generic defense strategies customized for their brands. This report contains case studies and actionable strategies pharmaceutical companies must know to retain market share and defend their patents.
To download a free summary of "Combating Generics: Pharmaceutical Brand Defense for 2007," please visit http://www.pharmagenerics.com/.
http://www.cuttingedgeinfo.com/ and http://www.pharmagenerics.com/