Tralement - (0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (1 mL) ; Injection)

Generic Name	Cupric Sulfate, Magnesium Sulfate, Selenious Acid, Zinc Sulfate	Innovator	AM Regent
Dosage	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (1 mL) ; Injection	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	TRALEMENT is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
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

Tralement - (0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL) ; Injection)

Generic Name	Cupric Sulfate, Magnesium Sulfate, Selenious Acid, Zinc Sulfate	Innovator	AM Regent
Dosage	0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL) ; Injection	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	TRALEMENT is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
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