Annora Pharma Pvt Ltd.

Weeks after snapping up the chronic kidney disease drug Velphoro in its $11.7 billion Vifor buyout, CSL pulled in a court win that gives it at least a few more years on the market without competition from Teva. US District Judge Maryellen Noreika of Delaware ruled on Thursday that Teva’s generic candidate for Velphoro — which has yet to be approved — would infringe on a patent held by Vifor Fresenius Medical Care Renal Pharma (VFMCRP), which is now part of CSL Vifor. The patent in question expires in July 2030, but CSL Vifor noted that Velphoro is protected by multiple patents that expire between 2029 and 2035. “We are vigorously defending our intellectual property and protecting our market position,” Florian Jehle, CEO of VFMCRP, said in a statement on Monday. “With this decision, we can continue to deliver this innovative drug to improve the lives of patients with chronic kidney disease on dialysis.” Velphoro, also known as sucroferric oxyhydroxide, is a chewable phosphate binder approved back in 2013 to control phosphate levels in adults with CKD on dialysis. The drug, which costs $1,381 out-of-pocket for a roughly 30-day supply, raked in nearly $186 million last year (CHF 179.2 million), up 0.8% from the year before. Teva submitted an abbreviated NDA for its generic sucroferric oxyhydroxide chewable tablets in 2017. Though the company argued that Vifor’s infringement claims were invalid for obviousness and lack of enablement, Noreika ruled that it failed to prove so. As a result, CSL Vifor won’t have to share its already small corner of the market, with just 100,000 patients using the drug on a yearly basis. VFMCRP has already settled patent disputes with both Lupin Pharmaceuticals and Annora Pharma, who have agreed to wait until an agreed-upon date to launch their own generics. Those dates are unclear, as VFMCRP said “details of all settlements are confidential.” Teva did not respond to a request for comment as of press time. Last August, Vifor Pharma filed a citizen petition over concerns that Velphoro and other complex IV iron products were lumped under the same name of  “ferric oxyhydroxide” in the FDA’s Orange Book. The company had previously requested NCE exclusivity for Velphoro, which the FDA didn’t award. Vifor blasts FDA's 'reckless' renaming of 4 drugs under the same molecule moniker CSL received regulatory clearance to close on the Vifor deal just a few weeks ago — months after initially announcing the deal. While CSL recently posted a dip in full-year profits due to a drop in plasma donations, CEO Paul Perreault assured investors and analysts that he’s leaving “no stone unturned” when it comes to growing plasma volumes. More information about the integration of Vifor is coming in October, Perreault added on the call. CSL CEO Paul Perreault determined to grow plasma collection after full-year sales dip