Tracleer (Actelion)
Patent expiry: November 2015   

2012 sales: $1.600 billion
2011 sales: $1.721 billion
Change: (7%)

Actelion has been the quintessential one-trick pony, and it won't be long before others will be able to copy its act. The trick is Tracleer, the biotech's blockbuster pulmonary arterial hypertension (PAH) treatment. The drug, which goes off patent in 2015, made up 87% of the company's revenues last year.

Actelion has a successor drug to Tracleer before the FDA now. Macitentan, aka Opsumit, has turned in good trial results for PAH, and the company has not tried to disguise the fact that its future is riding on approval. It trimmed some jobs last year but has also kept plowing money into R&D in an effort to broaden its portfolio.

Tracleer actually is already facing generic competition in Canada, and sales did slip some last year. The Swiss company believes it has good relations in the PAH community and that patients will remain loyal in the face of generics, but that may be wishful thinking. It has been hedging its bets just in case. The company recently was sued by generics makers Apotex and Roxane Laboratories for refusing to sell them samples of Tracleer to make their copies. Actelion responded that it can do business with whomever it chooses. The U.S. Federal Trade Commission (FTC), however, doesn't see it quite that way. The agency believes the practice is anticompetitive and is supporting the position of the makers of generic drugs.

For more:
Drugmakers 'illegally' withhold samples from would-be copycats
Actelion surges as positive PhIII macitentan data reignites buyout buzz


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