The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.
The patent cliff has continued, with the expiration of Purdue Pharma's patent on the long-acting opioid painkiller OxyContin (oxycodone), though companies looking to make generic versions have to include anti-tampering features; however, generic versions of another commonly abused opioid, Endo Pharmaceuticals' Opana ER (oxymorphone), won't need to include anti-tampering features.
The Food and Drug Administration is still working on regulations for biosimilars, as mandated by the Patient Protection and Affordable Care Act of 2010, which created an abbreviated regulatory approval pathway for them.
In addition to progress on the biosimilar front, the Supreme Court will soon reach decisions on two important generic drug industry cases. Federal Trade Commission v. Actavis, which DSN covered in its April issue, will decide the legality of patent settlements between branded and generic drug companies in which generic companies agree to hold off product launch in exchange for payment or the branded company agreeing to not launch an authorized generic. Another case, Mutual Pharmaceutical v. Bartlett, will decide if a generic drug company can be held liable for injuries caused by its products when those products are identical to their brand-name counterparts.
A lot will happen this year to affect the generic drug industry. The question is how will they play out?