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7 December 2021AmericasMuireann Bolger

Fresenius in patent dispute over hypocalcemia treatment

Fresenius Kabi is facing a lawsuit by two Pharmasphere subsidiaries over claims that it infringed a patent covering a treatment for hypocalcemia, a condition where the blood sugar (glucose) level is lower than normal.

HQ Specialty Pharma and Harpgrove WG Critical Care filed the lawsuit at the US District for the District Court of Delaware on Friday, December 3.

The patents-in-suit are US numbers 10,130,646 and 10,342,813, covering a solution indicated for the treatment of acute symptomatic hypocalcemia, which is provided in a ready-to-use flexible plastic bag to be administered intravenously without dilution.

The dispute arose when Fresenius submitted its supplemental New Drug Application to the US Food and Drug Administration (FDA) seeking approval to manufacture and sell calcium gluconate in sodium chloride injection solution in a bag before the expiration of the ’646 patent and the ’813 patent.

In August 2019, HQ Specialty Pharma sent a cease and desist letter entitled “Notice to Discontinue Compounding of Calcium Gluconate in Sodium Chloride Premix in Bags, FDA Approval of HQ Specialty Pharma’s New Drug Application 210906”, to Fresenius.

The FDA approved Fresenius’ ANDA in June 2021.

HQ and WG are seeking court orders blocking sales while the lawsuit is ongoing and until patents have expired, and cash compensation if the allegedly infringing compound is made or sold before then, according to the complaint.

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More on this story

Americas
15 April 2019   Fresenius Kabi has submitted a petition for inter partes review of US patent number 9,856,287, a patent owned by Amgen.
Americas
6 January 2017   Healthcare company Fresenius Kabi has targeted Sagent Pharmaceuticals in a patent infringement lawsuit centring on generic versions of Naropin.