According to a statement issued by BioMarin, the US drugmaker said it will grant Dr Reddy's a non-exclusive licence to its patents on Kuvan (sapropterin dihydrochloride) allowing the Indian drug maker to market a generic version of Kuvan 100mg tablets in the US at a later stage, which is expected to be more than five years from now.
Kuvan, which has clocked USD 203 million revenues for the company in 2014, is indicated for the treatment of hyperphenylalaninemia (HPA) in adults and children with phenylketonuria (PKU), who have been shown to be responsive to such treatment.
However, as per the statement, it can be done earlier under certain circumstances (which were kept confidential).
"The settlement agreement recognises the strength of the intellectual property related to Kuvan and helps ensure that patients who depend on Kuvan to manage their phenylketonuria (PKU) will continue to receive the medication and the range of support services offered to patients for years to come," Executive Vice-President and Chief Commercial Officer BioMarin, Jeff Ajer said.
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As required by law, BioMarin and Dr Reddy's will submit the agreement to the US Federal Trade Commission and the US Department of Justice, the statement further said.
Kuvan tablets are commercialised by BioMarin in the United States and Canada, and Merck Serono in the rest of the world outside Japan.