Merck has signed an authorized-generic deal with an unidentified company to market a generic version of its blockbuster osteoporosis drug Fosamax (Alendronate sodium trihydrate), which could go on sale next month.
Merck spokesman Ron Rogers declined to identify the generics company on Friday, saying details of the deal were proprietary at this time.
Fosamax's key U.S. patent is set to expire on Feb. 6, which will clear the way for generic competition.
Teva and Barr are planning to launch generic copies of Fosamax. Under federal law, Teva and Barr have been scheduled to be the only third-party marketers of generic Fosamax for about six months, because they were the first to file for Food and Drug Administration approval of generic Fosamax.
But the six-month exclusivity period doesn't stop Merck from selling its own generic, either by itself or with a generic-company partner. In recent years, Merck and other branded pharmaceutical companies have begun to strike these authorized-generic deals.
Critics say authorized-generic deals undercut the competitive advantage held by the generic companies that are supposed to have six-month exclusivity periods. Branded manufacturers, however, say the deals give consumers another generic option.
The Federal Trade Commission is now conducting a study of the competitive impact of authorized-generic deals. It recently requested information from numerous pharmaceutical companies about the deals.
Fosamax is one of Merck's best-selling drugs and was forecast to generate sales of $2.9 billion to $3.1 billion in 2007. However, sales are expected to plunge to $1.1 billion to $1.4 billion this year as a result of generic competition. Earlier this week, the FDA also advised doctors and patients about the possibility of severe and sometimes incapacitating bone, joint or muscle pain linked to Fosamax and other osteoporosis drugs.
Barr said Friday that it plans to launch a generic version of Fosamax 70 milligram tablets on Feb. 6 and that it is entitled to the 180-day exclusivity period.
"We had anticipated sharing the exclusivity with Teva for this product," the company said. "We are not surprised that Merck is launching an authorized generic, as this has become a common antigeneric strategy for brand companies."
A Teva spokeswoman couldn't immediately be reached for comment.
Merck spokesman Ron Rogers declined to identify the generics company on Friday, saying details of the deal were proprietary at this time.
Fosamax's key U.S. patent is set to expire on Feb. 6, which will clear the way for generic competition.
Teva and Barr are planning to launch generic copies of Fosamax. Under federal law, Teva and Barr have been scheduled to be the only third-party marketers of generic Fosamax for about six months, because they were the first to file for Food and Drug Administration approval of generic Fosamax.
But the six-month exclusivity period doesn't stop Merck from selling its own generic, either by itself or with a generic-company partner. In recent years, Merck and other branded pharmaceutical companies have begun to strike these authorized-generic deals.
Critics say authorized-generic deals undercut the competitive advantage held by the generic companies that are supposed to have six-month exclusivity periods. Branded manufacturers, however, say the deals give consumers another generic option.
The Federal Trade Commission is now conducting a study of the competitive impact of authorized-generic deals. It recently requested information from numerous pharmaceutical companies about the deals.
Fosamax is one of Merck's best-selling drugs and was forecast to generate sales of $2.9 billion to $3.1 billion in 2007. However, sales are expected to plunge to $1.1 billion to $1.4 billion this year as a result of generic competition. Earlier this week, the FDA also advised doctors and patients about the possibility of severe and sometimes incapacitating bone, joint or muscle pain linked to Fosamax and other osteoporosis drugs.
Barr said Friday that it plans to launch a generic version of Fosamax 70 milligram tablets on Feb. 6 and that it is entitled to the 180-day exclusivity period.
"We had anticipated sharing the exclusivity with Teva for this product," the company said. "We are not surprised that Merck is launching an authorized generic, as this has become a common antigeneric strategy for brand companies."
A Teva spokeswoman couldn't immediately be reached for comment.
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