Merck hit by US patent blow
pharmafile | February 1, 2005 | News story | Sales and Marketing |
Merck has lost 10 years of US patent protection for the best-selling formulation of its second-biggest selling drug, following a legal challenge.
The patent for the once-weekly version of Fosamax (alendronate sodium) will now expire in February 2008, at the same time as the original Fosamax patent, after a US federal appeals court ruling.
Fosamax is the world's most-prescribed treatment for postmenopausal, male and glucocorticoid-induced osteoporosis, earning $3.2 billion in 2004 – 90% of its sales come from the once-weekly formulation.
Generic challenger Teva says its own version of Fosamax will be eligible for FDA approval as soon as the osteoporosis treatment loses patent protection.
Teva is having a strong 2005, having received FDA approval in January for generic versions of Bristol-Myers Squibb's type II diabetes treatment Glucovance, Ortho-McNeil Pharmaceutical's antibiotic Levaquin and Pfizer's antifungal agent Diflucan.
Merck says it is considering its options, including a request for reconsideration by the Court of Appeals.
Meanwhile, Fosamax is also facing generic competition in Europe, where an EU court is considering striking down its patent, which would open the way to generic competition in 2007.
Merck is currently struggling with the fallout from the withdrawal of its blockbuster arthritis pain drug Vioxx, the immediate financial impact of which has been the loss of up to $750 million in fourth quarter sales.
In 2004, Merck's net income decreased by about 13% while global sales rose by just $400 million – pharmaceutical product sales were led by cholesterol treatment Zocor, Fosamax, antihypertensive Cozaar, and asthma treatment Singulair.
Merck expects Fosamax to increase its sales to $3.6 billion in 2005 and retain its number two product portfolio position behind Zocor.
Zocor's sales should reach $4.5 billion in 2005, but the drug is due to add to Merck's woes by losing US patent protection in 2006.
