Watson seeks regulatory approval for generic Adderall XR
PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.
British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.
Shire said Watson’s latest application is distinct from the one it filed in 2007 that resulted in a settlement between the two companies. Under the Hatch-Waxman Act of 1984, Shire has the right to file a patent infringement lawsuit against Watson in response to the latest application.
Patent protection for the drug expires in April 2019.