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Generated: November 15, 2018

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Details for New Drug Application (NDA): 209939

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NDA 209939 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 209939
Tradename:PREVYMIS
Applicant:Merck Sharp Dohme
Ingredient:letermovir
Patents:2
Generic Entry Opportunity Date for 209939
Generic Entry Date for 209939*:
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:
TABLET;ORAL

*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: 209939
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVYMIS letermovir TABLET;ORAL 209939 NDA Merck Sharp & Dohme Corp. 0006-3075 0006-3075-02 4 DOSE PACK in 1 CARTON (0006-3075-02) > 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01)
PREVYMIS letermovir TABLET;ORAL 209939 NDA Merck Sharp & Dohme Corp. 0006-3075 0006-3075-04 14 BLISTER PACK in 1 CARTON (0006-3075-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3075-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength240MG
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:➤ Try a Free TrialPatent Expiration:May 22, 2024Product Flag?YSubstance Flag?YDelist Request?

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