Warner Chilcott sues Mylan, Famy Care over Generess Fe patent challenge
PITTSBURGH — Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.
Mylan said Thursday that it and Famy Care had been sued by Warner Chilcott in the U.S. District Court for the District of New Jersey following their filing of a regulatory approval application with the Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets, a generic version of Warner Chilcott’s Generess Fe.
The application contains a paragraph IV certification, a legal assertion that patents covering Generess Fe are invalid, unenforceable or won’t be infringed. Between its April 2011 launch and Sept. 30, Generess Fe had sales of $4.5 million, according to IMS Health.
Ranbaxy launches generic Lipitor
SILVER SPRING, Md. — Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer’s cholesterol-lowering drug Lipitor.
The FDA announced the approval of Ranbaxy’s atorvastatin calcium tablets in the 10-mg, 20-mg, 40-mg and 80-mg strengths. New Brunswick, N.J.-based Ohm Labs will manufacture the drug.
"Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor," Ranbaxy CEO and managing director Arun Sawhney said.
Ranbaxy had been scheduled to launch earlier Wednesday to coincide with the expiration of Pfizer’s patent on Lipitor, but the FDA held off approval until the resolution of quality-control issues related to two of its manufacturing plants in India. Watson Pharmaceuticals announced the launch of its authorized generic version Wednesday morning.
Under federal law, Ranbaxy is entitled to 180 days of market exclusivity in which to compete directly with Pfizer. While the FDA is not allowed to give final approval to any other generic version of the drug until that exclusivity period is over, Watson still can market its authorized generic because it is the branded version of the drug marketed under its generic name and is thus not subject to regulatory approval.
Ranbaxy said that due to an agreement between it and Teva Pharmaceuticals USA, a portion of the profits from sales of the drug during the exclusivity period, though terms of the agreement were not disclosed.
Lipitor had sales of $7.8 billion during the 12-month period ended in September, according to IMS Health.
Mylan launches generic Caduet tablets
PITTSBURGH — Mylan said its subsidiary has launched a generic version of a hypertension treatment.
The company said Mylan Pharmaceuticals launched and begun shipping amlodipine besylate and atorvastatin calcium tablets in the 2.5-mg/10-mg; 2.5-mg/20-mg; 2.5-mg/40-mg; 5-mg/10-mg; 5-mg/20-mg; 5-mg/40-mg; 5-mg/80-mg; 10-mg/10-mg; 10-mg/20-mg; 10-mg/40-mg and 10-mg/80-mg strengths. The drug is a generic version of Pfizer’s Caduet.
Caduet tablets had U.S. sales of approximately $339 million for the 12 months ended Sept. 30, according to IMS Health.