Merck has entered into yet another authorized generic deal - this time for its blockbuster Fosamax. However, the name of the generic partner is unknown... Here is what was reported in today's New York Times:
"said on Friday it had signed a deal for an authorized generic form of its blockbuster osteoporosis drug Fosamax, to become available after the United States patent on the drug lapses on Feb. 6.
“We can confirm an authorized generic deal for Fosamax has been signed, although specific details of the deal are proprietary,” said a Merck spokesman, Ron Rogers.
Fosamax, whose chemical name is alendronate, has annual sales of about $3 billion, making it the world’s top-selling osteoporosis drug. Now available in a once-weekly formulation, it was the first member of the widely used family of treatments known as bisphosphonates that inhibit cells called osteoclasts that break down bone tissue.
An authorized generic is a copycat form of a company’s branded medicine that is sold through a licensing agreement, usually with a generic-drug manufacturer. Such deals allow the original seller of a branded drug to hold on to a greater revenue stream from the medicine once it loses patent protection and becomes prey to competition from generics.
An authorized generic can significantly hurt sales of rival generics waiting to be launched once a branded drug’s patent lapses.
Analysts have said cheaper generics will not only batter sales of Merck’s branded Fosamax, but could hurt another once-weekly bisphosphonate, Actonel, which is sold by Procter & Gamble and the French drugmaker Sanofi-Aventis.
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“I think generic Fosamax should do some damage to Actonel, but the impact to Boniva should be much less because Boniva is more differentiated as a once-monthly pill,” said Shaojing Tong, an analyst with Mehta Partners.
Barr Pharmaceuticals said Friday that it plans to launch its generic of the basic 70-milligram form of Fosamax on Feb. 6.
A spokeswoman for Barr said the company expects the Israeli drugmaker Teva Pharmaceutical Industries to launch its own generic about the same time and that Barr and Teva would share 180-day marketing exclusivity for their products. ....
Typically, the first generic-drug maker to seek approval of a generic form of a branded medicine is entitled to six months of marketing exclusivity in the United States, assuming its product is approved. But an authorized generic upsets that lucrative scenario.
Fosamax is also sold in a formulation that is combined with either 2,800 units or 5,600 units of Vitamin D, a nutrient that supports bone and other tissues.
The formulation with the lower dose of Vitamin D will lose United States patent protection two months after basic Fosamax, while the combination product containing the higher dose of Vitamin D will be patent-protected through 2010, according to Mr. Rogers of Merck.
Cowen & Company forecast in July that 85 percent of United States prescriptions for alendronate and up to half of international prescriptions will be generic this year.
It forecast that global sales of Fosamax would plunge to $1.85 billion in 2008, hurt by the generics, and decline to $800 million in 2009....
