Barr lifted as Shire Pharmaceuticals settles Adderall XR dispute

Shire Pharmaceuticals has agreed a settlement with generic rival Barr Pharmaceuticals, which sought to market a generic version of Shire's extended release Adderall XR drug used in Attention Deficit and Hyperactivity Disorder (ADHD) treatment. The companies have also agreed a six product development deal.

The settlement means Barr will be able to market a generic version of the drug in April 2009, in spite of the fact that Shire's patents extended to at least 2018.

Barr has also paid US$63m to Shire for the rights to market an older, "immediate release" version of the drug. Immediate release drugs of this nature have been controversial in the US because of their misuse as illegal amphetamines.

Bruce L. Downey, Barr's chairman and ceo said: "First and foremost, the agreements enable a pro-competitive and pro-consumer introduction of a generic version of Adderall XR more than nine years earlier than might otherwise have been possible. It will also result in an investment in research and development for six products initially, which will enhance our ability to expand our proprietary development activities. Finally, it provides us immediate access to the immediate-release Adderall brand product, a generic version of which we have manufactured and marketed since 2002."

Current annual sales for the branded Adderall product for the 12 months ended June 2006 are approximately $40 million, based on industry sources.

This agreement follows a spate of settlements, which have seen big pharmas offering large payments in order to keep generic competition at bay.

Dr Darren Smyth, partner at Marks & Clerk Patent and Trade Mark Attorneys, said: "These pay-offs have attracted stinging criticism, with claims that they are anti-competitive. The present settlement does not in-volve an exclusion payment of this nature."

Smyth continued: "Although today's settlement has been billed as a success for Shire, it is interesting to note that the company has sacrificed 9 years of the patent lifetime. There could be many reasons why they have chosen to do this, but one important factor is likely to be the confidence that Shire has in its drug pipeline, with its next generation ADHD treatment, NRP104, currently undergoing regulatory approval. This settlement illustrates just how easily an improved product can render prior monopolies expendable."

In the r&d agreement, Barr subsidiary Duramed has granted Shire a license to obtain regulatory approval for and market in certain specified territories Duramed's recently approved Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive product and five products in various stages of development using Duramed's transvaginal ring technology.