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no NDA has been filed for monotherapy at this time

The interaction between Orange Book patents and regulatory exclusivities creates a stacked protection system that the most sophisticated lifecycle management programs exploit through formulation patents, new indication exclusivities, and pediatric study timing

However, both Eli Lilly and Novo Nordisk have direct purchase options that greatly reduce the monthly price for patients that do not have insurance coverage

Example: 2 mg 5 mg/mL = 0.4 mL injection volume daily

N-Acetylcysteine (NAC) Precursor to Glutathione Legal Status : Approved as a prescription drug in some countries (e.g., the EU) for respiratory and liver conditions