Otsuka says Samsca generic infringes
Otsuka Pharmaceuticals has filed a patent infringement suit against MSN Laboratories targeting the company’s planned generic Samsca (tolvaptan) heart medication.
The Japanese drugmaker said that MSN’s abbreviated new drug application (ANDA) infringes two of Otsuka's patents, US patent 8,501,730 and 10,905,694.
The complaint, submitted to the US District Court for the District of Delaware, says that MSN Pharmaceuticals has asked the US Food and Drug Administration (FDA) to approve its generic prior to the expiration of the patents.
The patents, cover the formula and production method of the drug and are set to expire on September 1, 2026, and April 7, 2030, respectively.
Otsuka has asked the court to rule that MSN has infringed at least one claim of the two patents in suit and issue an order barring the sale or manufacturing of the generic prior to the expiration of the patents.
Samsca, also sold under the trade names Jinarc and Jynarque, was first launched in the US in May 2018. It is one of Otsuka’s top four performing drugs, generating $139 billion in sales in the fiscal year 2019.
Rexulti lawsuits
In February, Otsuka launched US litigation concerning another of its blockbuster drugs—its antipsychotic treatment Rexulti (brexpiprazole).
It filed a complaint in the same Delaware court alleging that Teva Pharmaceutical’s planned generic Rexulti tablets infringed five of its patents.
Similarly, it claimed that Teva sought FDA approval of its generic prior to the expiration of patents, which are currently licensed to Denmark drugmaker Lundbeck exclusively.
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