Olumiant - (1mg and 2mg ; Tablet)

Generic Name	Baricitinib	Innovator	Eli Lilly
Dosage	1mg and 2mg ; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Olumiant is a Janus Kinase (JAK) Inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Olumiant® (baricitinib) is also approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO, and for the treatment of adult patients with severe alopecia areata.
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
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Chronology Of Events

Olumiant - (4mg ; Tablet)

Generic Name	Baricitinib	Innovator	Eli Lilly
Dosage	4mg ; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Olumiant is a Janus Kinase (JAK) Inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Olumiant® (baricitinib) is also approved for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO, and for the treatment of adult patients with severe alopecia areata.
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