Injectafer - (750mg /15ml (50mg Iron/mL); Solution, Intravenous)

Generic Name	Ferric Carboxymaltose	Innovator	American Regent
Dosage	750mg /15ml (50mg Iron/mL); Solution, Intravenous	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	Indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron; who have non-dialysis dependent chronic kidney disease.
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

Injectafer - (1 g/20 mL (50mg Iron/mL) ; Solution, Intravenous)

Generic Name	Ferric Carboxymaltose	Innovator	American Regent
Dosage	1 g/20 mL (50mg Iron/mL) ; Solution, Intravenous	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron; who have non-dialysis dependent chronic kidney disease.
Complexities	Yes

Executive Summary

Chronology Of Events

Injectafer - (100mg /2mL (50mg Iron/mL) ; Solution , Intravenous)

Generic Name	Ferric Carboxymaltose	Innovator	American Regent
Dosage	100mg /2mL (50mg Iron/mL) ; Solution , Intravenous	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Injectafer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:  who have intolerance to oral iron or have had unsatisfactory response to oral iron;  who have non-dialysis dependent chronic kidney disease.
Complexities	Yes

Executive Summary

Chronology Of Events

Injectafer - (500mg /10ml ; Injection)

Generic Name	Ferric Carboxymaltose	Innovator	American Regent
Dosage	500mg /10ml ; Injection	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron; who have non-dialysis dependent chronic kidney disease.
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