Business Wire

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

Share

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220821005007/en/

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 (ASX:CSL; USOTC:CSLLY), 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

CSL Vifor Media Contact
Thomas Hutter
Mobile: +41 79 957 96 73
Email: media@viforpharma.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Huawei Publishes First White Paper on Approaches to Fairness, Equity & Opportunity2.12.2022 06:07:00 EET | Press release

Huawei called on the ICT industry players to create a level playing field for all people, not just their own employees in its first White Paper on Approaches to Fairness, Equity & Opportunity at their Women in Tech event held at the Peter Drucker Forum. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221201006045/en/ (Graphic: Business Wire) This White Paper is part of Huawei's ongoing campaign aimed at increasing digital skills education and access for women across the world. Huawei, like many other companies within the ICT industry, has advocated on fairness, opportunity, and equity within their own operations. Notably, the company has taken measurable steps to increase diversity in their workforce and increase internal representation of marginalized groups. It is widely understood that significant, tangible results from such programs are often slow to materialize. And thus Huawei has focused many of its efforts beyond the

H&M and Webhelp Finalize Acquisition of H&M’s Nuremberg Customer Service Center1.12.2022 18:29:00 EET | Press release

The responsible authorities have officially approved the transfer of fashion brand H&M’s Nuremberg customer service center to Webhelp, a leading global customer experience BPO player. The companies, having already signed an agreement in this regard on 19 October 2022, will see Webhelp operate the service center from 1 December onwards under its own name. With this acquisition, Webhelp doubles the number of its employees in Nuremburg and is now one of the largest employers in the industry in northern Bavaria. Today, Webhelp employs more than 110,000 employees in over 60 countries. Webhelp's German headquarters in Nuremberg already provides an attractive working environment with state-of-the-art technical equipment for over 500 employees. Furthermore, Webhelp is committed to investing in the development and wellbeing of its customer advisors, known as 'game-changers,' around the world. Webhelp will welcome the 500 employees of the H&M Service center from today, 1 December, to the Webhelp

Morgan Stanley Sustainable Signals: New Survey Shows Opportunities Exist for Asset Managers to Better Meet Asset Owner Sustainable Investing Needs1.12.2022 18:00:00 EET | Press release

Asset managers have the opportunity to meet asset owners’ growing demands for sustainable investment practices, products and reporting, according to new research by the Morgan Stanley Institute for Sustainable Investing. The latest in the Firm’s Sustainable Signals series, this institutional investor survey polled 110 asset owners in North America, Europe and Asia, as well as 201 asset managers across the same regions to understand what asset owners want and what asset managers are offering—and where the gaps lie in delivering environmental, social and governance (ESG) solutions. “The results of our latest Sustainable Signals survey show that sustainable investing remains an important focus area for institutional investors globally, with the vast majority reporting an increased interest over the past two years,” said Jessica Alsford, Chief Sustainability Officer and CEO of the Institute for Sustainable Investing at Morgan Stanley. “At the same time, our findings show a significant oppo

Successful Product Innovations and Portfolio Acquisition Drive Wella Company to Exceed Profit and Growth Expectations in Successful Second Year1.12.2022 17:12:00 EET | Press release

Wella Company, a global leader in the $100 billion hair and nail segment of the beauty industry, is marking a successful second year as a standalone company, delivering year-over-year double-digit profit and growth ahead of expectations. In Fiscal Year 22, which closed at the end of June, Wella Company beat all targets on financial performance across the globe. Since its founding in December 2020, Wella Company has delivered continuous double-digit profit and growth ahead of expectations and is one of the fastest-growing beauty companies in the sector. Wella Company’s portfolio includes iconic professional and retail hair, nail, and beauty tech brands Wella Professionals, O·P·I, ghd, Briogeo, Nioxin, Sebastian Professional, and Clairol. “Our first two years of business have shown the enduring potential of the Wella Company portfolio – we are re-establishing category excellence in both hair and nails, and both professionals and consumers are falling in love again with our beautiful bran

Sermo Survey Finds Opportunity to Educate General Care Physicians on PrEP to Increase Patient Adoption1.12.2022 17:05:00 EET | Press release

Timed to World AIDS Day, Sermo, a physician-first online community and leader in global HCP insights, released a new survey that found 46% of general care physicians including PCPs, OB-GYNs, and pediatric physicians, reported they feel they do not have enough knowledge about currently approved PrEP medication options to prescribe them to patients. Whereas 98% of infectious disease specialists reported they felt they have enough knowledge about PrEP medications signaling a need for further education from industry stakeholders for noninfectious disease specialists. An important area of opportunity as patients who are likely good candidates for PrEP often go to a PCP instead of seeking out an infectious disease specialist. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221201005355/en/ The cost of PrEP continues to be a driving factor for patients’ decision to decline treatment in the U.S. as reported by 26% of surveyed physici

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom