Prevymis - (240, 480 mg ; Tablet)

Generic Name	Letermovir	Innovator	Merck
Dosage	240, 480 mg ; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	PREVYMIS is a CMV DNA terminase complex inhibitor indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
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

Prevymis - (240MG/12ML, 480MG/24ML)

Generic Name	Letermovir	Innovator	None
Dosage	240MG/12ML, 480MG/24ML	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	PREVYMIS is a CMV DNA terminase complex inhibitor indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Complexities	Yes

Executive Summary

Patent Status

Chronology Of Events

Prevymis - (20MG, 120MG)

Generic Name	Letermovir	Innovator	None
Dosage	20MG, 120MG	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: • Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). • Prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).
Complexities	Yes

Executive Summary

Patent Status

Chronology Of Events