Summary and Analysis
A federal judge has ruled that a lawsuit brought by 42 states against Suboxone manufacturer Indivior may proceed. The states have accused the pharmaceutical firm of using illegal tactics to shield its opioid addiction treatment drug, Suboxone, from generic competition.
So far, the FDA has approved three medications (buprenorphine, methadone and naltrexone) aimed at managing opioid withdrawal symptoms and reducing opioid cravings. Two of these drugs—buprenorphine and methadone—are themselves opioids and are carefully regulated and tightly controlled. Both have a significant potential for overdose, abuse and diversion. Suboxone is a combination of two drugs: buprenorphine and naloxone.
Like other opioids, Suboxone causes physical dependency when taken regularly over a long period of time. Numerous studies have shown that many people who use Suboxone illicitly often do so in an effort to self-treat or self-manage opioid withdrawal symptoms. Non-medically supervised use of Suboxone is dangerous, particularly when the drug is injected. Injecting Suboxone comes with the risks of developing abscesses, infections, and acquiring bloodborne illnesses such as HIV and hepatitis. (see the article The Dangers of Suboxone)
Excerpted from Reuters
(Reuters) – Drugmaker Indivior Inc must face a lawsuit by 42 state attorneys general accusing it of using illegal tactics to shield its opioid addiction treatment Suboxone from generic competition, a federal judge has ruled. States have said that the company’s conduct forced consumers to pay inflated prices for the treatment amid an epidemic of opioid addiction.
U.S. District Judge Mitchell Goldberg in Philadelphia found Monday that a reasonable jury could find that Indivior’s switch from a pill to an oral film form of the drug in 2009 was intended to extend its monopoly just as generic manufacturers were poised to begin selling their own pills, a strategy known as product hopping.