Gilead patent for Ranexa challenged by Lupin
FOSTER CITY, Calif. Indian generic drug maker Lupin is challenging a Gilead Sciences patent for a drug that treats chronic angina, Gilead said.
Gilead said it received a notice that Lupin had filed an approval application with the Food and Drug Administration for a generic version of Ranexa (ranolazine) extended-release tablets. Lupin’s application contained a Paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that Gilead’s patents covering Ranexa are invalid, unenforceable or won’t be infringed by Lupin’s version.
Under the Hatch-Waxman Act, Gilead has 45 days from the receipt of the letter to file a patent infringement lawsuit against Lupin. Such a suit would prohibit the FDA from approving Lupin’s version of the drug for two and a half years or until the court rules against Gilead. The patents covering Ranexa are set to expire in 2019, according to FDA records.
Lobbying for FMAP extension: It makes sense
WHAT IT MEANS AND WHY IT’S IMPORTANT Chain and independent pharmacy retailers learned a long time ago that going to bat for disadvantaged consumers in the communities they serve often can make good economic sense, as well as make them good corporate citizens. Their current campaign to convince Congress to extend the temporary federal boost in medical assistance for lower-income Americans hit hard by a brutal recession is a perfect case in point.
(THE NEWS: Pharmacy groups seek federal medical assistance percentage extension. For the full story, click here)
Five national pharmacy and retail groups – the National Association of Chain Drug Stores, National Community Pharmacists Association, American Pharmacists Association, Food Marketing Institute and National Alliance of State Pharmacy Associations – have joined forces to plead with the Senate for continued indirect relief for those Americans. Their goal: to convince federal lawmakers to pass legislation that would extend the additional medical assistance funding now going to programs like Medicaid that provide a health safety net for the millions of long-term or recently unemployed or underemployed Americans and their dependents.
The program is called FMAP, for federal medical assistance percentage. Created under the American Recovery and Reinvestment Act, it opened a wider funding spigot for states staggered by the recession and the resulting loss of tax revenues, allowing them to continue providing their share of health benefits to lower-income people through such programs as Medicaid.
All well and good, considering the enormous burden the financial meltdown has put on tens of millions of Americans. But FMAP, as currently written, is set to expire at the end of calendar 2010. And it’s increasingly apparent that states will continue to reap the bitter harvest of this recession long after that expiration date as they struggle to make up drastic funding shortfalls.
Indeed, NACDS and the other pharmacy groups pushing for an extension of FMAP predict the state budgetary crisis will continue to plague state-administered medical assistance programs for at least two more years, “with state budget deficits approaching $180 billion.” Their answer, contained in a June 8 written plea to Senate majority leader Harry Reid, D-Nev., minority leader Mitch McConnell, R-Ky., and other top lawmakers, is straightforward: extend the program for another six months, through June 30, 2011.
It goes without saying that serving as a champion for hard-hit healthcare consumers is both an altruistic gesture and a solid way for pharmacy retailers to build long-term gratitude and loyalty among those consumers. But lobbying Congress for an extension of FMAP also makes good business sense. Pharmacy leaders are, in essence, assuring the economic viability and ongoing market support of those customers.
“We strongly believe,” the pharmacy groups told Reid and McConnell, “that extending the current FMAP increases, as part of the tax extenders legislation or as standalone legislation, is critical to serving the healthcare needs of some of our most vulnerable citizens, and to assist states grappling with enormous budget challenges.”
FDA evaluating Benicar trials
SILVER SPRING, Md. The Food and Drug Administration said Friday it was evaluating data from two clinical trials of a hypertension drug to investigate a possible risk of cardiovascular-related death in diabetic patients.
The two trials, “ROADMAP” and “ORIENT,” compared Daiichi Sankyo’s Benicar (olmesartan medoxomil) with placebo in patients with Type 2 diabetes. Still, the FDA cautioned that it had not concluded that Benicar raises the risk of death and said that the drug’s benefits for patients with hypertension outweighed its potential risks.
The FDA said it would review the primary data from the two studies, which were designed to determine whether Benicar slowed the progression of kidney disease in Type 2 diabetes patients.
Benicar and Benicar HCT (olmesartan modoxomil and hydrochlorothiazide) had combined U.S. sales of around $971 million, according to Daiichi Sankyo financial data, based on current yen-dollar exchange rates.