Impax confirms patent challenge for generic Concerta
HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.
Impax Labs on Tuesday confirmed that Alza Corp., a subsidiary of Johnson & Johson, filed a patent infringement suit against Impax in connection with Concerta (methylphenidate hydrochloride) extended-release 54-mg tablets. Impax filed its abbreviated new drug application for a generic version of Concerta with the Food and Drug Administration in November 2002, and submitted Paragraph IV patent certifications in connection with two patents that were listed in the FDA’s Orange Book in 2005.
Impax said its generic Concerta products are part of its strategic alliance agreement with Teva Pharmaceuticals. Once the ANDA is approved by the FDA, Teva will commercialize the products, the drug maker said.
U.S. sales of Concerta in the 54-mg strength approximately were $365 million for the 12 months ended Sept. 30, according to Wolters Kluwer.
WomenCare Global buys two oral contraceptive brands
CHAPEL HILL, N.C. — WomenCare Global has acquired two oral contraceptive brands from ICON, WomenCare said Monday.
The company acquired Roselle (levonorgestrel and ethinylestradiol) and Optinor (levonorgestrel). ICON developed both drugs under a partnership with an unnamed generic drug manufacturer.
“This partnership with WomenCare Global is a significant step forward in expanding access to quality-assured generic hormonal contraceptives at competitive prices,” ICON general manager David Smith said in a statement.
Impax challenges Abbott’s Simcor patent
HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.
Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.
Impax’s application contained a paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that the patent covering Simcor is invalid or unenforceable, or that Impax’s version won’t infringe upon it. Abbott responded last Wednesday by filing a patent infringement suit against Impax in the U.S. District Court for the District of Delaware.