FDAnews
www.fdanews.com/articles/62976-barr-to-launch-adderall-ir

BARR TO LAUNCH ADDERALL IR

October 2, 2006

Barr Pharmaceutical announced Sept. 28 that it is now free to close a deal with Shire, acquiring the rights to Shire's attention-deficit/hyperactivity disorder drug Adderall immediate-release (IR) tablets. The initial 30-day waiting period on the agreement, required by the Hart-Scott-Rodino Antitrust Improvements Act, expired on Sept. 27 without further FTC action, Barr said in a statement.

Now the company can complete an Aug. 14 agreement transferring Adderall IR rights to Barr subsidiary Duramed Pharmaceuticals. Duramed acquired Shire's Adderall (immediate-release mixed amphetamine salts) tablets for $63 million after Shire dropped a lawsuit against Barr as part of a patent settlement involving Shire's extended-release Adderall XR.

The agreement allows Duramed to sell the brand version of the drug as well as the generic, which it already makes. In exchange, Shire will pay Duramed up to $165 million for a license to market, in certain territories, Duramed's Seasonique (levonorgestrel/ethinyl estradiol) birth control tablets and five other Seasonique products currently in development.

Barr expects to launch Adderall IR in the quarter ending Dec. 31, according to the release. The drug made $42.1 million in 2005.