It’s Giving Tuesday! When we raise $100k, another $100k is unlocked GIVE NOW

OxyContin’s waiting game: Generic drug makers salivate while the FDA wants safer pills

Dan Gorenstein Apr 16, 2013
HTML EMBED:
COPY

OxyContin’s waiting game: Generic drug makers salivate while the FDA wants safer pills

Dan Gorenstein Apr 16, 2013
HTML EMBED:
COPY

Patent protection for the painkiller OxyContin expires today. That means generic drug manufacturers hope to soon grab a chunk of the nearly $3 billion market. But first, the FDA must give its blessing — but right now, that’s far from certain.

OxyContin is one of the most dangerous and widely abused drugs available. And the FDA is hesitant is to flood the market with a painkiller that’s easily abused. So no matter how anxious generic drug makers are, RBC Capital Markets analyst Shibani Malhotra says the firms may have to wait.

“Every single company executive that we’ve spoken to believes that the market is going to have to move to tamper resistant products,” Malhotra says. 

The FDA may require tamper-resistant drugs, like a pill that’s impossible to crush into powder.

But Justin Collishaw, with Frost & Sullivan, says requiring tamper-resistant safeguards makes it harder for generics to get into the game. 

“Do I think that a generic manufacturer would develop their own tamper resistant formulation? The margins are not there,” Collishaw says.

Industry observers believe the issue is so thorny, the FDA may remain silent over the coming weeks.  

We’re here to help you navigate this changed world and economy.

Our mission at Marketplace is to raise the economic intelligence of the country. It’s a tough task, but it’s never been more important.

In the past year, we’ve seen record unemployment, stimulus bills, and reddit users influencing the stock market. Marketplace helps you understand it all, will fact-based, approachable, and unbiased reporting.

Generous support from listeners and readers is what powers our nonprofit news—and your donation today will help provide this essential service. For just $5/month, you can sustain independent journalism that keeps you and thousands of others informed.