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Drug maker's legal battle with the FDA delays generic competition

Endo Pharmaceuticals games the system by asking the FDA to rule that an old version of its drug is unsafe

It is a highly popular prescription medicine. Unfortunately, Opana is also highly popular in the wrong circles.

The drug is an opioid pain reliever similar to OxyContin. And like OxyContin, Opana is often abused. Millions of people throughout the nation crush prescription opioids like these (to defeat the pills’ extended release design), then inject or snort the medications in order to get a quick, powerful high.

Gaming the System

Innovative drug companies (and their innovative lawyers) have come up with a variety of ways to game the legal system in order to delay generic competition. One common technique is “evergreening” or “product hopping”: Before the patent on a popular drug expires, the manufacturer obtains a patent on a slightly modified version of the drug. For instance, the new version may be a capsule instead of a tablet; the amount of the active ingredient may be increased, so fewer pills need be consumed at one time; or the new version may have an extended time release formula. There are all sorts of possible modifications. 


Steven Seidenberg

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