Pfizer reaches agreement with Impax over generic Detrol

Generics/News | Posted 07/09/2012 post-comment0 Post your comment

Pfizer has reached an agreement with Impax Laboratories (Impax) over the production and marketing of a generic drug alternative to the bladder-control treatment Detrol LA (tolterodine tartrate). The two companies have ‘settled a patent lawsuit’ based on a licence agreement dated 16 August 2012 that prohibits Impax from selling generic versions of Detrol LA ‘except as permitted under the settlement and license agreement.’


The agreement is the culmination of a court battle since 2008 when Impax first informed Pfizer of its application for FDA approval for generic Detrol LA, which is produced as extended-release capsules. Impax has its own proprietary controlled-release drug delivery technologies and formulation skills to create physiologically identical generic versions of brand-name products. Detrol and Detrol LA are lucrative targets, given that they generated US$883 million in global sales in 2011 for Pfizer. Impax currently has 39 Abbreviated New Drug Applications pending, at least seven of which have first-to-file or first-to-market potential, according to the company website.

Meanwhile, a 2010 lawsuit to prevent Mylan Pharmaceuticals from marketing a different generic form of Detrol LA has yet to reach conclusion. Reuters reports that the primary patent for Detrol LA expires in September 2012, while the patents for three additional Detrol formulations expire in 2020.

Pfizer and Impax are not revealing the details of the agreement, which adds to a growing concern over lack of transparency in settlements between pharmaceutical companies and generic producers.

Related articles

Is the end in sight for pay-for-delay?

Problematic patent settlements in EU on the decrease

Source: Bloomberg, Impax Laboratories, Reuters

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010