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.
Savient’s Krystexxa launches in the United States
EAST BRUNSWICK, N.J. — Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.
The drug maker announced the U.S. commercial launch of Krystexxa (pegloticase).
"Since receiving FDA approval for Krystexxa, we have focused on preparing for a successful U.S. launch," said John Johnson, Savient CEO. "Our sales force has completed very thorough and extensive training. We are excited to deploy this highly talented and biologics experienced team into their territories. There has never been a more exciting time in the history of Savient, nor for the chronic gout patients, who have waited so long for a therapy that has the potential to change the course of their lives."
Par sees sales gains across all sectors
WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.
Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.
Leading products for the year included metoprolol succinate, a generic version of AstraZeneca’s high blood pressure treatment Toprol XL, which had sales of $73 million for the quarter and $473.2 million for the year; as well as sumatriptan, a generic version of GlaxoSmithKline’s migraine treatment Imitrex, which had sales of $19.9 million during the quarter and $73 million for the year as a whole.
Among branded products, the breast cancer treatment Megace ES (megestrol) had sales of $14.8 million for the quarter and $60.9 million for the year, while the vitamin B12 deficiency treatment Nascobal B12 (cyanocobalamin) nasal spray had sales of $4.8 million for the quarter and $17.7 million for the year.