Goodbye to Accutane--as generic competitors step in
Branded Accutane (isotretinoin), which first went on the market in 1982 for the treatment of severe acne, is no longer available for prescription. The pharmaceutical company Roche Holding AG (Basel, Switzerland) announced that it was discontinuing sales and withdrawing Accutane from the market as of June 26, 2009. The pharmaceutical company made the decision on the heels of a lawsuit which awarded over $33 million in damages to users who said the drug was responsible for causing inflammatory bowel disease. In addition, Roche has been forced to spend large amounts of money to defend themselves against many personal-injury lawsuits, including six cases that Roche lost after trial. In addition to the high costs of lawsuits, the branded drug had been reduced to less than 5% of isotretinoin’s market share after a slew of generic competitors hit the market in 2002. Before the drug’s patent expired, Accutane was Roche’s second biggest selling drug.
The drug going off the market is a disappointment for those with severe or intractable cystic acne. Roche has also been a leader in developing a rigorous risk-management program alongside the FDA for the prevention of birth defects and education regarding Accutane’s possible health risks. The good news is that because the drug was not pulled for safety reasons, it’s generic competitors will remain available for prescription.