CSL-VIFOR
22.8.2022 07:02:36 CEST | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220821005007/en/
Link:
About Business Wire
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
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 01:00:00 CEST | Press release
Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and KeytrudaPhase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sour
Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 00:00:00 CEST | Press release
Megaport DDoS Protection removes the trade-off between security, performance, and cost, offering rapid enterprise-grade mitigation. Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing s
IFF Reports First Quarter 2026 Results5.5.2026 22:23:00 CEST | Press release
Delivered solid top and bottom line Q1 resultsProgressing disciplined sale process for Food Ingredients businessReaffirms Full Year 2026 Financial Guidance IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks t
Logitech Announces Q4 and Full Fiscal Year 2026 Results5.5.2026 22:06:00 CEST | Press release
Strong FY 2026 Demonstrates Strategy and Operating Principles Are Delivering SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2026. For Fiscal Year 2026: Sales were $4.84 billion, up 6 percent in US dollars and 4 percent in constant currency compared to the prior year. GAAP operating income was $775 million, up 18 percent compared to the prior year. Non-GAAP operating income was $911 million, up 18 percent compared to the prior year. GAAP earnings per share was $4.80, up 16 percent compared to the prior year. Non-GAAP EPS was $5.78, up 19 percent compared to the prior year. Cash flow from operations was $1.04 billion. The year-ending cash balance was $1.7 billion. The Company returned $768 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2026: Sales were $1.09 billion, up 7 percent in
Sentinel Midstream Advances Texas GulfLink Deepwater Port5.5.2026 22:00:00 CEST | Press release
Marks Historic Milestone for U.S. Energy Export Infrastructure under the U.S.-Japan Trade Deal Sentinel Midstream LLC (Sentinel) today announced the commencement of its Texas GulfLink deepwater port (Texas GulfLink or the Project), marking a significant milestone enabled by funding received pursuant to the U.S.—Japan Trade Agreement. The project advances in coordination with the U.S. Department of Commerce and the Government of Japan and reflects the shared commitment to strengthening global energy security and expanding U.S. export infrastructure. Sentinel will lead the development of Texas GulfLink, overseeing construction, commercial operations, and long-term management of the terminal. Funding provided under the U.S.—Japan Trade Agreement, pursuant to Executive Order 14345 signed on September 4, 2025, underscores continued international confidence in U.S. energy infrastructure and supports the expansion of American crude oil exports to global markets. Upon this commencement, Texas
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