What changes the calculus: if a generic manufacturer successfully challenges Novo Nordisk's formulation patents as invalid or files an ANDA with a Paragraph IV certification (claiming the patents are invalid or not infringed), they could trigger a 30-month stay during which the FDA cannot approve the generic
Rizzo D, Barone G, Ruggiero A, Maurizi P, Furfaro IF, Castagneto M, et al
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