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Endo to receive royalties from generic opioid it once called 'unsafe': 7 things to know

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Amid growing rates of opioid overdoses in 2012, Endo International pulled a version of its best-selling painkiller, Opana ER, from the market, categorizing the drug as dangerous and susceptible to abuse, according to a report from CNN.

While the action appeared to be spurred by concern for public safety, some close observers of the drug industry suggest Endo’s move highlighted the lengths companies will go to protect profits from generic competition.  

Here are seven things to know.

1. Opana ER — extended release oxymorphone — is a highly potent extended release opioid meant to be swallowed and released over the span of 12 hours. However, after being crushed the drug can be snorted or injected, which bypasses the drug’s time-release mechanism.

2. Before Endo pulled the Opana ER from the market in 2012, the company introduced a new formulation of the drug designed to be harder to crush, to reduce the likelihood of abuse.

3. Once the original version of the drug was off the market, Endo also petitioned the Food and Drug Administration to officially declare the drug was removed for safety reasons, which would prevent other companies from selling a generic version of the drug. The FDA did not issue such a declaration, and Endo sued the agency a month before Impax Laboratories was scheduled to release a generic version of Opana ER, which was previously the center of a patent infringement lawsuit between the two drugmakers.

4. The FDA argued Endo’s conduct was a “thinly-veiled attempt to maintain its market-share and block generic competition from Impax,” according to CNN. A court dismissed Endo’s lawsuit against the agency, and Impax’s generic version went to market.

5. In July 2017, Endo removed its abuse-deterrent formulation of Opana ER from the market per the FDA’s request. However, Impax’s version of the original Opana ER remains on the market. The FDA declined to comment on why the original formulation remains available, but told CNN the agency is assessing abuse patterns and possible safety issues for that drug and all oxymorphone drug formulations.

6. Prior to pulling the crush-resistant opioid this year, Endo reached a deal with Impax to share profits for generic extended-release oxymorphone for the next 11 years, starting Jan. 1, 2018. The deal allows “Endo to be fairly compensated for Impax’s license to use Endo’s valuable intellectual property in offering the product for use as intended,” Endo told CNN. However, critics point out Endo is profiting off of the very drug it said was unsafe to stay on the market.

7. In 2016, Impax made $72.7 million on the generic. Endo made $159 million on Opana ER sales the same year.

“Patient safety is very important to us,” said Impax in a statement to CNN. “We believe that our product is an effective therapy for patients with chronic pain when used as directed by a physician and in accordance with the label/package instructions.”

To read the full report from CNN, click here.

More articles on opioids: 
After directive from Trump, HHS declares opioid crisis public health emergency 
FDA commissioner: Trump administration ‘took a historic step’ addressing opioids 
WellCare Health Plans’ pilot program cuts opioid dispensing in half

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