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VFMCRP announces U.S. Court upholds validity of Velphoro® patent

U.S. District Court for the District of Delaware rules Teva Pharmaceuticals infringes VFMCRP patent

Disputes with all other Abbreviated New Drug Application (ANDA) filers regarding Velphoro® have been settled

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that the U.S. District Court for the District of Delaware issued a judgment in VFMCRP's favor regarding U.S. patent no. 9,561,251 which covers the formulation for Velphoro® (sucroferric oxyhydroxide). The decision, subject to appeal, holds that the generic sucroferric oxyhydroxide product proposed by Teva Pharmaceuticals USA, Inc., in its Abbreviated New Drug Application (ANDA) will infringe the Velphoro® U.S. patent no. 9,561,251, which expires in July 2030 (including pediatric extension). Currently, Velphoro® is protected by multiple Orange Book listed patents which expire between May 2029 and May 2035.

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A further ANDA patent infringement lawsuit against Teva based on patents no. 10,682,376, no. 10,695,367 and no 11,013,761, all expiring in May 2029 remains pending.

"CSL Vifor welcomes the decision by the U.S. District Court to uphold the patent validity of Velphoro® which highlights the innovation and strength of our intellectual property," said Florian Jehle, Chief Executive Officer of VFMCRP. "We are vigorously defending our intellectual property and protecting our market position. With this decision, we can continue to deliver this innovative drug to improve the lives of patients with chronic kidney disease on dialysis."

VFMCRP has previously settled disputes with Lupin Pharmaceuticals, Inc and Annora Pharma Pvt. Ltd. which had filed ANDAs to market a generic version of Velphoro®. These ANDA filers will be able to launch a generic version of Velphoro® in the United States on an agreed-upon date. Details of all settlements are confidential.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).

The parent company, CSL (CSLCSLLY, headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com.

About Velphoro®

Velphoro® is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood of adults with chronic kidney disease on dialysis. Velphoro® has been launched in 32 countries at the end of 2021, with more than 100,000 patients estimated to use the drug on a yearly basis.

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