It’s only been two days since Endo International filed for bankruptcy in a bid to get out of thousands of opioid lawsuits. Today, one of its best sellers is in trouble.

A federal appeals court on Thursday upheld a Delaware judge’s ruling that Eagle Pharmaceuticals’ generic version of Endo’s Vasostrict vasopressin injection does not infringe the company’s patents. Eagle’s version was approved in December, and already the generic and similar ones have been driving down sales of Vasostrict.

Vasostrict is made by Endo’s Par Pharmaceutical unit and grossed $900 million last year, doubling revenue from Endo’s second-best-selling product, Xiaflex for men with Peyronie’s disease.

Even though vasopressin has been marketed as a therapeutic agent for nearly a century, Par won approval in 2014 as part of an FDA initiative to encourage manufacturers to get older drugs approved. not approved. The drug is approved to raise blood pressure in adults with vasodilator shock who remain hypotensive despite fluids and catecholamines.

However, last quarter sales fell 85% from Q2 2021 due to “lower prices and market share resulting from generic competition,” the company said.

In addition to Eagle, Dr. Reddy’s and Amphastar also changed approvals for their own generic versions.

Par filed a lawsuit against Eagle in 2018, around the same time Eagle submitted its ANDA. The plaintiffs argued that the generic would infringe two patents, which expire in 2035 and require vasopressin to have a rounded pH between 3.7 and 3.9. However, a Delaware court ruled last August that Eagle’s product did not exceed the limits because its pH range was lower than that covered by the Par patents.

While acknowledging the lower pH of generic Eagle, Par pointed to evidence that the pH of Eagle’s product would increase over time, infringing the patents.

A federal appeals court upheld the court’s original decision on Thursday, noting:

The district court’s finding that there was no upward pH drift in Eagle’s post-release pH data was not an obvious error. The court carefully reviewed the post-release pH data that Par cites, as well as Eagle’s expert testimony evaluating that data, and found that while the pH readings fluctuated over time, there was no There was no discernable trend – and certainly not an inevitable upward trend – in the fluctuation.

Endo declined to comment.

The news comes days after Endo filed for bankruptcy in a mountain of opioid lawsuits, following in the footsteps of Purdue Pharma and Mallinckrodt. The company has faced a litany of complaints over its former opioid painkiller Opana ER, which was pulled from the market in 2017 at the request of the FDA.

Endo filed for Chapter 11 on Wednesday, while also reaching a $450 million opioid settlement with multiple states.

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