Purdue Pharma and generic drugmaker Actavis ($ACT) have settled their patent suit over a special formulation of the painkiller OxyContin just 10 days afer the FDA banned generic versions that do not carry abuse resistant technology.
Actavis will be allowed to sell its version of the tamper resistant drug starting Jan. 1, 2014, assuming the FDA gives it approval by September. If not, then the deal calls for Actavis to market a limited amount of an authorized generic starting in October. OxyContin pulled in $2.8 billion in the U.S. in the 12 months ending Jan. 31, 2013, Actavis said.
In 2010, Purdue brought out the reformulated version, which it spent about $100 million developing. But earlier this month, the patent on its original version was set to expire. For months FDA regulators wrestled with the dangers of allowing a flood of cheap, generic versions of the original formulation of the drug to hit the market. That version can easily be crushed by addicts wanting a quick, cheap, heroin-like high. Some members of Congress and some law enforcement officials had urged the FDA to ban generics of the highly-abused drug.
On April 15, the day the patent was to expire, the FDA ruled "the benefits of original OxyContin no longer outweigh its risks" and banned any copies from approval. The agency also said it would allow those companies with tamper protected formulations to make a "label claim."
The FDA is urging drugmakers to develop more tamper-resistant meds to meet the needs of patients suffering from chronic pain. "The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Dr. Douglas Throckmorton, deputy director for regulatory programs at FDA's CDER, said when the FDA announced the ban on the generics.
- here's the Reuters story