5th Oct 2015 09:11
LONDON (Alliance News) - Indivior PLC Monday said it has received notification from Sandoz Inc indicating it has submitted an abbreviated new drug application to the US Food and Drug Administration for a generic formulation of Indivior's 8 milligram/2 milligram Suboxone sublingual film product.
Suboxone is a treatment for opiate addiction.
Indivior said that Sandoz is the sixth company to file such an application regarding the product. Sandoz is seeking approval for the application before the expiration of three of Indivior's patents covering the product, on the basis that these patents are invalid, unenforceable and or will not be infringed by its product.
Indivior said it intends to initiate a patent infringement lawsuit against Sandoz, as it intends to assert and enforces its intellectual property, which will automatically trigger a stay of FDA approval of the application.
Shares in Indivior were down 0.2% at 231.60 pence Monday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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