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
BitGo sikrer OCC-godkendelse til konvertering til føderalt chartret National Trust Bank13.12.2025 02:12:00 CET | Pressemeddelelse
Sætter ny standard for institutionel digital aktivinfrastruktur med samlet føderal tilsyn BitGo Holdings, Inc. (“BitGo”), virksomheden inden for digital aktivinfrastruktur, annoncerede i dag, at Office of the Comptroller of the Currency (“OCC”) godkendte virksomhedens ansøgning om at konvertere BitGo Trust Company, Inc., et trustselskab registreret i South Dakota, til en nationalbank ved navn BitGo Bank & Trust, National Association (N.A.). Med dagens OCC-godkendelse af konverteringen fungerer BitGos datterselskab af Trust Company nu som BitGo Bank & Trust, National Association (N.A.). BitGo Bank & Trust, N.A. vil operere under et enkelt, ensartet føderalt tilsynssystem, der gør det muligt at levere den klarhed, styring og reguleringssikkerhed, som institutioner forventer af et føderalt reguleret fiduciært selskab. Denne godkendelse styrker BitGos position som et institutionelt fundament for det moderne finansielle system, der kombinerer tilsyn på bankniveau med den sikkerhed, complian
FIA, Formula 1 Group and All 11 Race Teams Officially Sign the Ninth Concorde Agreement, Securing Strength and Stability for the Sport in Pivotal Five-Year Agreement12.12.2025 17:10:00 CET | Press release
Multi-year Concorde Governance Agreement signed by the FIA, Formula 1 Group and all 11 teams, securing the World Championship through 2030 Paves the way for a more professionalised sport and represents a new era of collaboration between the FIA and Formula 1 Group Long-term commitment enhances sporting reliability, global reach and stability for teams, fans and broadcasters The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, and Formula 1 Group, the Commercial Rights Holder, have today announced the signing of the Concorde Governance Agreement, a crucial contract defining the regulatory framework and governance terms of the FIA Formula One World Championship until 2030. This follows the announcement in March that the 2026 Commercial Concorde Agreement had been signed by all the teams and Formula 1 Group. Together, these agreements constitute the ninth Concorde Agreement, representing a m
Anabranch Capital Management, LP supports relisting of SmartCraft ASA to Nasdaq Stockholm12.12.2025 16:26:00 CET | Press release
Reference is made to the stock exchange announcement by SmartCraft ASA ("SmartCraft" or the "Company") on 1 December 2025 regarding the contemplated relisting of SmartCraft from Euronext Oslo Børs to Nasdaq Stockholm (the "Relisting") and the announcement of a cross-border merger to effect the Relisting. Funds managed by Anabranch Capital Management, LP (“Anabranch”) intend to vote in favour of the merger plan resolved by the boards of SmartCraft and its Swedish wholly owned subsidiary, SmartCraft Group AB (publ), to effect the Relisting at the Company's extraordinary general meeting planned for January 2025 (the "EGM"). Anabranch intends to vote with all Anabranch shares held at the Record Date for the EGM in favour of the relisting effected by the merger plan. Funds managed by Anabranch currently hold approximately 15.9 million shares in SmartCraft. Disclaimer: The views expressed are those of the authors and Anabranch Capital Management, LP as of the date referenced and are subject
Mohammed Ben Sulayem Re-Elected as President of the FIA12.12.2025 15:49:00 CET | Press release
The Fédération Internationale de l’Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, today confirms that Mohammed Ben Sulayem has been re-elected as President of the FIA, following the election of his Presidential List by the General Assembly in Tashkent, Republic of Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212213181/en/ President Mohammed Ben Sulayem now begins his second four-year term, having overseen a period of significant renewal and stabilisation for the organisation since his initial election in 2021. Over the past four years, the FIA has undergone a wide-ranging transformation, improving governance, operations and restoring the financial health of the federation. These changes have strengthened the FIA’s position as the world’s governing body for motorsport and the leading authority on safe, sustainable, and affordable mobility.
Perma-Pipe International Holdings, Inc. Announces Third Quarter 2025 Financial Results12.12.2025 15:00:00 CET | Press release
Net sales of $61.1 million for the quarter and $155.8 million year-to-date.Income before income taxes of $10.9 million for the quarter and $21.1 million year-to-date.Diluted earnings per share of $0.77 for the quarter and $1.49 year-to-date.Backlog of $148.9 million at October 31, 2025, up from $138.1 million at January 31, 2025. Perma-Pipe International Holdings, Inc. (NASDAQ: PPIH) announced today financial results for the third quarter ended October 31, 2025. “For the three months ended October 31, 2025, net sales were $61.1 million, an increase of $19.5 million, or 46.9%, compared to $41.6 million in the same quarter of the prior year. Growth was driven by higher sales volumes in both the Middle East and North America. Gross profit was $21.0 million, up $6.9 million from $14.1 million last year, reflecting higher activity levels. Selling, general and administrative expenses increased to $8.3 million from $7.3 million, primarily due to higher payroll and professional fees, including
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