INOmax - (100 ppm and 800 ppm; Gas; for Inhalation)

Generic Name	Nitric Oxide	Innovator	Mallinckrodt
Dosage	100 ppm and 800 ppm; Gas; for Inhalation	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	Less Than 5	Generic Launches	Less Than 5
Indication	INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
******* ************, ***.	*** / **	*** **, ****	*** ** ** *** **	********	******** ** *** **, ****
****** ************ ***	** / **	*** **, ****	******* / ********* **** ** **	********	******** '**-****' ** *** **, ****

Chronology Of Events