Fresenius Kabi files suit against Claris Lifesciences over anesthesia drug

Claris Lifesciences today said US-based Fresenius Kabi has filed a suit against the company to block commercialisation of its abbreviated new drug application (ANDA) for Propofol, used to induce or maintain anesthesia during surgeries.

“Fresenius Kabi USA has filed a suit against the company on December 19 in the US District Court, District Delaware, seeking to prevent the company from commercialising its ANDA prior to the expiration of its existing patent on 1 December, 2024,” Claris Lifesciences said in a filing to the BSE.

The company has filed a an ANDA for Propofol injection in strength of 10 mg/ml with the US Food and Drug Administration (FDA), it added.

Claris’s ANDA is a generic version of Diprivan, which is indicated for general anaesthesia for surgery or other medical procedures.

“The company has received satisfactory opinions from consultants and legal advisors that the claims of the patent will not be infringed by the company’s product,” Claris said.

If the company wins, then it will be able to launch the product significantly prior to the expiry of the patent, it added.

According to the IMS health data as on 14 June, Propofol injection had an annual market size of around $251 million in the US.

Claris Lifesciences shares closed at Rs 177.25 a piece on the BSE, down 1.03 percent from its previous close.

PTI