Merck won't be outdone on Fosamax. The company has struck a deal with an unidentified generics supplier for an authorized, copycat form of the osteoporosis drug. The Merck-blessed generic could go on sale as early as next month.
You'll recall that Fosamax's key patent is due to expire [1] Feb. 6, and two generics makers--Teva Pharmaceutical Industries and Barr Pharmaceuticals--are first in line. Because they were first to ask the FDA for approval for their versions of Fosamax, they have six-month exclusivity. But that exclusivity doesn't apply to Merck itself, which could sell its own generic form or do so with a partner.
This type of arrangement--for an authorized generic--has come under fire [2] as more and more pharma companies have begun to engage. Critics say they destroy the competitive advantage that six-month exclusivity is designed to confer; now, the Federal Trade Commission is studying the deals
- read the Wall Street Journal article [3]
Related Articles:
US Senate to take on authorized generics. Report [2]
Merck expects $1.8B hit on Fosamax. Report [1]
Merck touts Fosamax data. Report [4]
Merck profits jump by 62 percent. Report [5]
Links:
[1] http://www.fiercepharma.com/story/merck-expects-1-8b-hit-fosamax/2007-12-04
[2] http://www.fiercebiotech.com/story/us-senate-to-take-on-authorized-generics/2006-07-21
[3] http://online.wsj.com/article/SB120008726578884597.html?mod=googlenews_wsj
[4] http://www.fiercebiotech.com/story/also-noted-fda-expands-use-of-plavix-merck-touts-fosamax-data-and-much-more/2006-08-17
[5] http://www.fiercepharma.com/story/spotlight-merck-profits-jump-62-percent/2007-10-22