Anchen hopes to override patents for Shire ADHD drug
DUBLIN Generic drug maker Anchen Pharmaceuticals is seeking regulatory approval for a generic version of an attention deficit hyperactivity disorder drug made by British drug maker Shire, Shire said Tuesday.
Shire said it had received notice that Anchen had filed a regulatory approval application with the Food and Drug Administration comtaining a paragraph IV certification, an official assertion that the patents covering Intuniv (guanfacine hydrochloride) extended-release tablets are invalid, unenforceable or won’t be infringed. Anchen’s certification is the third, after recent ones by Teva Pharmaceuticals USA and Actavis Elizabeth.
The three patents that Anchen hopes to override expire in 2015, 2020 and 2022, though the FDA can’t approve a generic version of Intuniv until September 2012, when Shire’s exclusivity period ends.
In other news, Shire said last week that it had filed a lawsuit against Teva in the U.S. District Court for the District of Delaware, alleging infringement of two of the patents covering Intuniv.
Mylan begins marketing generic ADHD treatment
PITTSBURGH Mylan has begun marketing a generic version of a drug for attention deficit hyperactivity disorder, the generic drug maker announced Monday.
Mylan’s methamphetamine hydrochloride tablets in the 5 mg strength are a generic version of Lundbeck’s Desoxyn and are the first generic version of that drug to gain approval from the Food and Drug Administration.
Methamphetamine hydrochloride tablets had sales of $9.3 million in 2009, according to IMS Health.
NACDS Foundation contributes $150,000 to Haiti relief efforts
PALM BEACH, Fla. The charitable arm of the National Association of Chain Drug Stores has contributed $150,000 to assist Haiti relief efforts following the devastating earthquake that struck the island nation.
The NACDS Foundation’s contributions included $50,000 each to organizations that have been immersed in this important work since the January earthquake: Doctors Without Borders, AmeriCares, and Convoy of Hope. Among their areas of expertise, Doctors Without Borders focuses on healthcare delivery; AmeriCares delivers much-needed medicines, medical supplies, water purification tablets, baby food and other resources; and Convoy of Hope provides meals, medical supplies and water filtration systems to places in need.
“Haiti has disappeared from the front pages of our newspapers, but it will take decades of work to restore the land of these proud people,” said NACDS Foundation chairman of the board and NACDS CEO Steve Anderson. “These contributions reflect the many, many steps that pharmacy chains and suppliers, and others across industries have made to assist Haiti at this time.”
Anderson announced the contributions during his remarks at the NACDS Annual Meeting in Palm Beach, Fla.
“The NACDS Foundation’s vision is to improve the health and wellness of the people in America, and the NACDS Foundation board of directors decided wisely to extend this vision globally amid the ongoing and tremendous need in Haiti,” said NACDS Foundation president Edith A. Rosato. “Our commitment to helping those in Haiti knows no bounds and we truly hope that this contribution will assist in the relief effort, and help maintain a focus on the long-term needs of the Haitian people.”
In addition to this contribution, the NACDS Foundation is matching dollar-for-dollar contributions of NACDS and NACDS Foundation staff members to Hope for Haiti, as part of the Green for Jeans program. Through this program, staff members make donations for the privilege of wearing jeans to work on Fridays.