Ranbaxy launches generic Aricept
GURGAON, India, and PRINCETON, N.J. — Ranbaxy Pharmaceuticals has received final approval for its generic Alzheimer’s drug from the Food and Drug Administration, giving the drug maker 180 days of market exclusivity.
Ranbaxy Pharmaceuticals, a subsidiary of Ranbaxy Labs, will manufacture and market donepezil hydrochloride tablets, a generic version of Aricept, in the 5-mg and 10-mg strength in the United States.
"We are pleased to announce the launch of donepezil, which expands Ranbaxy’s portfolio of affordable generic pharmaceuticals. Ranbaxy’s generic formulation of Aricept will benefit the U.S. healthcare system by providing a more affordable treatment option to patients, which will have a positive impact on escalating U.S. healthcare costs," said Bill Winter, VP trade sales at RPI.
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.