It’s just two days after Endo International filed for bankruptcy to get out of thousands of opioid lawsuits. Now that top seller he has one problem.
A federal appeals court on Thursday upheld a Delaware judge’s ruling that Eagle Pharmaceuticals’ generic version of Endo’s vasopressin injection Vasostrict did not infringe the company’s patents. However, generics and other similar products are already weighing down Vasostrict’s sales.
Vasostrict is manufactured by Endo’s Par Pharmaceutical division, which generated a whopping $900 million in revenue last year. This more than doubles the revenue of Endo’s second best-selling product, his Xiaflex for men with Peyronie’s disease.
Vasopressin has been marketed as a therapeutic drug for nearly a century, but Parr received approval in 2014 as part of an FDA initiative to encourage manufacturers to seek approval for older, unlicensed drugs. This drug is approved to raise blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
However, last quarter sales were down 85% from the second quarter of 2021 due to “price and market share declines from generic competition,” the company said.
In addition to Eagle, Dr. Reddy’s and Amphastar have also obtained approval for their own generic versions.
Par filed a lawsuit against Eagle in 2018, around the same time Eagle filed its ANDA. Plaintiffs argued that the generic drug, which expires in 2035, infringes two patents that claim vasopressin to have a rounded pH between 3.7 and 3.9. It was ruled that Eagle’s product does not exceed its pH range because it falls below the range covered by Par’s patent.
While acknowledging the low pH of Eagle’s generic drug, Par pointed to evidence that the pH of Eagle’s products increased over time, infringing the patent.
A federal appeals court upheld the original court decision on Thursday, stating:
The district court’s finding that there was no upward pH drift in the post-release pH data of the Eagle was not clearly erroneous. The court thoroughly examined the post-release pH data, along with testimony that Eagle experts evaluated the data, and found that while pH readings fluctuated over time, there was no discernible trend and inevitable We found that there was no significant upward trend. Fluctuation.
Endo declined to comment.
The news comes days after Endo filed for bankruptcy under a mountain of opioid lawsuits, following in the footsteps of Purdue Pharma and Mallinckrodt. of opioid analgesics, Opana ER.
Endo filed for Chapter 11 on Wednesday, reaching a $450 million opioid settlement with several states.