Stelara - (130mg/26mL ; Injection)

Generic Name	Ustekinumab	Innovator	Janssen Pharma
Dosage	130mg/26mL ; Injection	Branded US Sales	More Than $1000 mn
Probable FTF	None	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	Less Than 5	Generic Launches	None
Indication	STELARA® is a human interleukin-12 and -23 antagonist indicated for the treatment of adult patients with : moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy; active psoriatic arthritis (PsA), alone or in combination with methotrexate; moderately to severely active Crohn’s disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker, or failed or were intolerant to treatment with one or more TNF blockers.
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