US District Judge Maryellen Noreika of Delaware ruled on Thursday that Teva’s generic candidate for Velphoro — which has yet to be approved — would infringe on a patent held by Vifor Fresenius Medical Care Renal Pharma (VFMCRP), which is now part of CSL Vifor.
ST. GALLEN, Switzerland--(BUSINESS WIRE)--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.
EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis.
Daiichi Sankyo Company, Limited announced that a Board of Directors Meeting resolved that American Regent, Inc. and PharmaForce, Inc., subsidiaries of Luitpold Pharmaceuticals, Inc. are to undergo an absorption-type merger with Luitpold as the surviving company. The name of said surviving company, Luitpold, is to be changed to American Regent, Inc., effective January 2019.
On February 17, 2016, the Kolkata Patent Office’s, S. Kundu, Deputy Controller of Patents and Designs, (Kolkata Patent Office) issued an Order allowing VIFOR INTERNATIONAL AG (VIFOR or Company) Indian Patent Application Number 3919/KOLNP/2006 (Patent Application) to proceed to grant. As a result, VIFOR, a Switzerland based company (part of the Galencia Group) specializing in development of pharmaceuticals that treat iron deficiencies, received its tenth (10th) patent in India. The Patent Application relates to the “process for producing a novel composition and the use of said composition as phosphate adsorbent, especially for administration in humans or animals”.
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