Endo scores victory in Opana ER generics patent battle

Endo Health Solutions ($ENDP) has been facing an uphill battle with its pain med Opana ER, working hard to thwart generic competition for the drug as sales take a hit. But the company is enjoying a bright point in its saga, winning a ruling in a U.S. District Court which bars generic copycats of Opana.

U.S. District Judge Thomas Griesa of the U.S. District Court for the Southern District of New York upheld two of Endo's patents for the drug, preventing generic competition for Opana until the patents expire in 2023, Bloomberg reports. The ruling covers a non-abuse deterrent version of the drug sold by Allergan's ($AGN) generics business Actavis. Actavis has two months to take its generic version of Opana off the market, and Griesa will decide later whether the company will also have to pay damages to Endo.

Endo has also filed similar suits against generic drugmakers such as Teva Pharmaceuticals ($TEVA), Par Pharmaceutical, Sandoz and Mallinckrodt ($MNK). But the company settled with Mallinckrodt and Par and dismissed suits against Teva and Sandoz after the companies said they would not pursue a new drug application for a non-crush-resistant version of Opana.

"We are very happy with today's outcome and are reviewing the ruling in greater detail to determine its long-term impact," Endo CEO Rajiv De Silva said in a statement.

The win comes at a critical moment for Endo, as it fights to hold onto sales of Opana amid increased generic competition. In 2013, the drugmaker lost a bid to keep generic companies from copying the med after the FDA decided that the company's tamper-resistant formula did not actually prevent drug abuse better than earlier versions without the abuse-deterrent feature.

"We think the public health would not be served if a company can market itself as 'abuse deterrent,' if the scientific evidence did not support that claim," Douglas Throckmorton, a deputy director in the FDA's Center for Drug Evaluation and Research, said at the time.

In October, the company was slapped with a lawsuit by a Farmingdale, NY-based construction workers' health and welfare fund, which accused the Dublin-based drugmaker of paying off Impax Laboratories ($IPXL) to keep its Opana copy off the market between June 2010 and January 2013. Impax is still allowed to market its version of Opana under Griesa's recent ruling.

The drama appears to have taken its toll on Endo. Net sales for Opana through June 2015 dropped to $90 million from $101 million during the same period last year. And sales "continue to be impacted by competing generic versions" of its non-crush resistant formulation of the drug, the company said in a recent SEC filing. The latest court decision could be exactly what Endo needs to recover from its string of bad tidings with Opana.

- here's Endo's statement
- read the Bloomberg story
- get Endo's SEC filing

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