Empowering generic drugs to reduce the impact of expired drug patents

Merck is taking proactive steps to mitigate the financial impact of the upcoming patent expiration for its blockbuster drug, Fosamax. To prepare for this, the company is set to launch an authorized generic version of the medication. On January 14, Merck confirmed it has entered into an agreement with an undisclosed partner. The generic version of Fosamax 70 mg is expected to be available on February 6, marking a strategic move to maintain market presence and revenue. In the third quarter of last year, Fosamax generated sales of $725 million. Analysts from Cowen & Co. estimate that the drug's U.S. sales reached as high as $3 billion in recent years, but projections suggest a significant decline to $1.85 billion by 2009—a drop of over 50%. This decline underscores the urgency for Merck to secure its position in the market through generic alternatives. Barr Pharmaceuticals and Teva Pharmaceuticals are also preparing to launch their own generic versions of Fosamax on February 6, aiming to secure the 180-day exclusivity period. This strategy could significantly affect existing competitors, particularly Actonel, a drug jointly marketed by Procter & Gamble and Sanofi-Aventis. Doctors may increasingly prefer the more affordable generic options, further pressuring branded pharmaceutical companies. Recent studies have raised concerns about the safety of Fosamax and Novartis' Zometa, linking them to an increased risk of atrial fibrillation. As a result, all bisphosphonate drugs are currently under review by the FDA. This regulatory scrutiny adds another layer of complexity for Merck and other manufacturers as they navigate the evolving landscape of drug regulation and market competition.

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