CSL-VIFOR
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
Galderma Opens up New Chapter for Sculptra® with MDR Certification and New Expanded Indication for Body5.12.2025 07:00:00 CET | Press release
Sculptra®, the first proven regenerative biostimulator, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include gluteal area, posterior thighs, décolletage, and upper arms1 Studies investigating the efficacy of Sculptra on areas beyond the face show patients experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour Sculptra’s versatility and new indication allow practitioners to shift patient treatment goals beyond rejuvenation toward enhancement, meeting evolving patient needs The certification validates Sculptra’s safety performance, efficacy, and quality, reinforcing Galderma’s commitment to innovation and meeting evolving patient needs Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its
Northern Escape Heli-Skiing Takes the Title of “World’s Best Heli-Ski-Operator” for the 4th Year Running5.12.2025 02:40:00 CET | Press release
4x World’s Best Heli-Skiing Operation near Terrace, BC Northern Escape Heli-Skiing (NEH) has been named World’s Best Heli-Ski Operator 2025 by the World Ski Awards, marking its fourth straight victory following years 2022, 2023 and 2024. This recognition places NEH amongst an elite group of ski tourism operators consistently voted best in the world by industry leaders and enthusiasts alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204074550/en/ A four-year run built on reliability NEH operates in British Columbia’s Skeena Mountains, where deep northern snow and vast terrain come together with small-group heli-skiing and heli snowboarding. When helicopters can’t safely fly, NEH has cat skiing readily available as a backup — an exceedingly rare offering in this industry. The operation spans over 833,571 wild acres of alpine bowls, glaciers and old-growth tree skiing. The NEH experience Guests choose from three lodge f
IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance5.12.2025 01:00:00 CET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers. IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development. Dr. Yue
Helical Fusion, Developer of Next-Generation Clean Energy Through Nuclear Fusion, Completes USD 5.5M Series A Extension Round5.12.2025 01:00:00 CET | Press release
Stakeholder base expands with participation from an individual-investor-oriented fund, alongside corporate and individual investors, bringing Total Funding to USD 38M Helical Fusion Co., Ltd. (Head Office: Chuo-ku, Tokyo; CEO: Takaya Taguchi; hereafter “Helical Fusion”), which is developing a next-generation energy source using Japan’s original Helical Stellarator technology to realize commercially viable fusion power plant in the 2030s, announced the completion of its Series A Extension round, raising approximately USD 5.5 million (≈ JPY 870 million). The round included investments from “Ecrowd NEXT”, a fund designed for individual investors, as well as multiple corporate investors and individual investors. As a result, Helical Fusion’s total Series A funding, including loans, amounts to approximately USD 21 million (≈ JPY 3.2 billion), bringing the company’s cumulative fundraising—including grants and loans—to approximately USD 38 million (≈ JPY 6.0 billion). With this funding, Helic
Andersen Consulting udvider sin tilstedeværelse gennem samarbejde med Hilal Technology4.12.2025 23:04:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Hilal Technology for at styrke sine kompetencer inden for digital infrastruktur, cybersikkerhed og AI. Med tilstedeværelse i Bahrain, Saudi-Arabien, De Forenede Arabiske Emirater, Oman og Indien leverer Hilal Technology et komplet spektrum af digital infrastruktur og managed services inden for cloudcomputing, cybersikkerhed, enterprise ai og systemintegration. Deres ydelser omfatter cloudtjenester, sikkerheds- og netværksdrift, implementering af ERP og applikationer samt udvikling af generative ai-kapaciteter. Med et team på mere end 250 fagfolk servicerer firmaet en bred vifte af brancher, herunder den finansielle sektor, olie og gas, logistik og den offentlige sektor. "Transformation er mere end systemer; det handler om parathed, tillid og løbende samarbejde," udtaler Roshan George, direktør for Hilal Technology. "Vi er begejstrede for at samarbejde med Andersen Consulting og levere skalerbare løsninger, der matcher tempoet i den dig
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