Rigel Pharmaceuticals, Inc. (RIGL) Thursday announced that it has entered into a settlement agreement with Annora Pharma Private Ltd., Hetero Labs Ltd., and Hetero USA, Inc. resolving patent litigation related to Rigel's product Tavalisse (fostamatinib disodium hexahydrate).
The litigation resulted from submission by Annora of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Tavalisse in the United States.
Under the terms of the settlement agreement, Annora will have a license to sell its generic product in second quarter of 2032 or earlier under certain circumstances.
In accordance with the agreement, the parties terminated all ongoing litigation between Rigel and Annora regarding Tavalisse patents pending in New Jersey.
"The resolution of this patent litigation underscores the strength of Rigel's intellectual property protecting TAVALISSE, an innovative treatment for people with immune thrombocytopenia," said Raul Rodriguez, Rigel's president and CEO. "We remain committed to advancing our portfolio of novel therapies with the potential to improve the lives of patients with hematological disorders and cancer, and to continue to develop and enhance our intellectual property portfolio."
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