Bulletin: Mallinckrodt PLC INOmax Competitor Approval To Slowly Erode Sales; Incremental Negative To Credit

NEW YORK (S&P Global Ratings) Oct. 5, 2018--The U.S. Food and Drug Administration (FDA) recently announced the Annotated New Drug Application (ANDA) approval of Praxair Inc.'s Noxivent, a generic version of Mallinckrodt PLC's second-largest product, INOmax (nitric oxide about 15%-20% of revenue). This follows a recent court judgement invalidating certain Mallinckrodt patents. S&P Global Ratings views this as only incrementally negative for Mallinckrodt. Our ratings on the company are unchanged, given our expectation of only gradual erosion of INOmax sales when Noxivent is eventually launched, which we expect to occur following the FDA approval of Noxivent's delivery device and the resolution of legal appeals. We think Mallinckrodt's competitive position in INOmax is better protected than for a typical pharmaceutical product

...NEW YORK (S&P Global Ratings) Oct. 5, 2018--The U.S. Food and Drug Administration (FDA) recently announced the Annotated New Drug Application (ANDA) approval of Praxair Inc.'s Noxivent, a generic version of Mallinckrodt PLC's second-largest product, INOmax (nitric oxide about 15%-20% of revenue). This follows a recent court judgement invalidating certain Mallinckrodt patents. S&P Global Ratings views this as only incrementally negative for Mallinckrodt. Our ratings on the company are unchanged, given our expectation of only gradual erosion of INOmax sales when Noxivent is eventually launched, which we expect to occur following the FDA approval of Noxivent's delivery device and the resolution of legal appeals. We think Mallinckrodt's competitive position in INOmax is better protected than for a typical pharmaceutical product because of multi-year service contracts with customers and extensive client service and distribution infrastructure. We believe hospital customers see this nitric oxide...

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