Pharmaceutical companies prepare as Plavix, other blockbuster drugs lose patent protectionIn yet another major loss for a pharmaceutical giant, the blockbuster drug Plavix is set to lose patent protection this year.

Plavix, which Bristol-Myers Squibb sells in the U.S. through an agreement with Sanofi-Aventis, is one of the most popular drugs in the world. Since first hitting pharmacy shelves in 1997, Plavix has become one of the most prescribed and utilized medical therapies in cardiovascular health.

The drug helps prevent blood clots that could potentially lead to heart attack and stroke in at-risk patients, Steven Nissen, the chairman of the Cleveland Clinic's cardiovascular medicine department, said in an interview with The New York Times. He added that when used in conjunction with aspirin, Plavix was significantly reducing the incidence of such potentially fatal cardiac events.

The drug manufacturing sector has been upended over the past few years, as other lucrative prescription medications also lost patent protection and large biotechnology firms went on acquisition sprees. On Thursday, the pharmaceutical intellectual property rules that had formerly prevented Plavix from being sold in generic form will expire, and experts said the repercussions would be felt throughout the healthcare sector.

In anticipation of the likely drop in sales, Bristol-Myers Squibb said it would not actively promote Plavix. Though the loss of patent protection is a blow to the pharmaceutical giant's revenue, it will ultimately benefit consumers as lower-priced generic versions of the medicine are produced.

Bristol-Myers Squibb and other biotechnology companies are reeling from such losses. Pfizer, the largest such U.S. business, has struggled to drive sales of Lipitor since the drug lost patent protection last year. In 2012, the pharmaceutical industry is set to lose a total of $38.5 billion because of the expiration of such non-competition provisions.

Companies have mulled a number of varying responses to the loss of patent protection, though none have emerged as a clear winner. Pfizer, for instance, has slashed its research and development and implemented ambitious cost reduction initiatives, campaigns that have thus far pleased shareholders. However, the company's pipeline has lagged as a result, and analysts have questioned whether such decisions would prove prescient or ill conceived over the long-term.

The loss of the sole rights to Plavis will likely have an outsized impact on Bristol-Myers Squibb. According to the company, sales of the drug hit $7.1 billion in 2011, a figure representing approximately 35 percent of total revenue. Over the course of its lifetime, Plavix has generated nearly $43 billion in sales.

Regulators have thus far given seven pharmaceutical companies the authority to manufacture and sell a generic form of Plavix, according to the Times. Companies across the globe actively work to prepare for the expiration of patent protections, as the pharma supply chain is circuitous and laden with complex safety rules. Uday Baldota, a Sun Pharmaceutical Industries spokesperson, asserted the firm often spends between seven and eight years readying for the introduction of a new medication.

Underscoring how careful logistics and business planning ultimately pays off, a generic version of Plavix is set to hit the U.S. market Friday, a mere 24 hours after Bristol-Myers Squibb officially loses its stranglehold on the drug.

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