Epogen - (40,000 Unit/mL; Vial, Multidose)

Generic Name	Epoetin alfa	Innovator	Amgen
Dosage	40,000 Unit/mL; Vial, Multidose	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	Less Than 5
Indication	Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
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