Invega Trinza - (546 mg/1.75 mL; Extended-release Injectable Suspen)

Generic Name	Paliperidone Palmitate	Innovator	Janssen Pharma
Dosage	546 mg/1.75 mL; Extended-release Injectable Suspen	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	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	Invega Trinza (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA
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

Invega Trinza - (819 mg/2.625 mL;Extended-release Injectable Suspen)

Generic Name	Paliperidone Palmitate	Innovator	Janssen Pharma
Dosage	819 mg/2.625 mL;Extended-release Injectable Suspen	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	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	INVEGA trinza® is an atypical antipsychotic agent indicated for Treatment of schizophrenia
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

Invega Trinza - (273 mg/0.875 mL and 410 mg/1.315 mL Extended-relea)

Generic Name	Paliperidone Palmitate	Innovator	Janssen Pharma
Dosage	273 mg/0.875 mL and 410 mg/1.315 mL Extended-relea	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	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	INVEGA TRINZA®, a 3-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA® (1-month paliperidone palmitate extended-release injectable suspension) for at least four months.
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