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Generated: November 18, 2018

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Details for New Drug Application (NDA): 209940

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NDA 209940 describes PREVYMIS, which is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PREVYMIS profile page.

The generic ingredient in PREVYMIS is letermovir. One supplier is listed for this compound. Additional details are available on the letermovir profile page.
Summary for 209940
Tradename:PREVYMIS
Applicant:Merck Sharp Dohme
Ingredient:letermovir
Patents:2
Generic Entry Opportunity Date for 209940
Generic Entry Date for 209940*:
Constraining patent/regulatory exclusivity:
PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
Dosage:
SOLUTION;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 209940
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940 NDA Merck Sharp & Dohme Corp. 0006-5003 0006-5003-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) > 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)
PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940 NDA Merck Sharp & Dohme Corp. 0006-5004 0006-5004-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5004-01) > 24 mL in 1 VIAL, SINGLE-DOSE (0006-5004-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength240MG/12ML (20MG/ML)
Approval Date:Nov 8, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 8, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 8, 2024
Regulatory Exclusivity Use:PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
Patent:➤ Sign UpPatent Expiration:May 22, 2024Product Flag?YSubstance Flag?YDelist Request?

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