Branded drug: Adderall XR
U.S. sales: $1.3 billion
Companies: Teva Pharmaceutical Industries, $799 million; Global Pharma, $516 million
To show up on both the best-selling generics list and a couple of drug shortages lists is somewhat of a feat, but that reflects the byzantine nature of the availability of generic Adderall. The extremely popular drug, first brought to market by Shire ($SHPG), is for the treatment of attention-deficit hyperactivity disorder (ADHD), one of the most commonly diagnosed childhood disorders. But because the drug contains a controlled substance, the Drug Enforcement Administration gives drug manufacturers annual quotas of how much they can make, which they say do not meet demand. Critics say the DEA is stingy given the rapid rise in sales of Adderall and other ADHD drugs. IMS data shows there was an 83% increase in sales of ADHD drugs between 2006 and 2011. The DEA says there is plenty of supply. Any shortages of generics it blames on manufacturers choosing to use more of their quotas to make the pricier branded versions instead of more generics.
Shire has been the only Adderall XR supplier. It sells a branded version, of course, and supplies two authorized generics to Teva Pharmaceutical Industries ($TEVA) and Global Pharmaceuticals, the generics division of Impax Laboratories ($IPXL). That cozy arrangement will soon be tested. The FDA in June approved Actavis, now owned by Watson Pharmaceuticals ($WPI), to be the first third-party rival. That approval came in more than a year earlier than expected.
FDA hits Shire with early nod for Adderall XR copycat
DEA quotas allow ADHD generics to run short
Shire shrugs off blame for Adderall shortage