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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 219104


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NDA 219104 describes PREVYMIS, which is a drug marketed by MSD and Merck Sharp Dohme and is included in three NDAs. It is available from one supplier. There are three 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 219104
Tradename:PREVYMIS
Applicant:Msd
Ingredient:letermovir
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219104
Generic Entry Date for 219104*:
Constraining patent/regulatory exclusivity:
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Dosage:
PELLETS;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: 219104
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREVYMIS letermovir PELLETS;ORAL 219104 NDA Merck Sharp & Dohme LLC 0006-5085 0006-5085-01 1 PACKET in 1 CARTON (0006-5085-01) / 30 PELLET in 1 PACKET
PREVYMIS letermovir PELLETS;ORAL 219104 NDA Merck Sharp & Dohme LLC 0006-5086 0006-5086-01 1 PACKET in 1 CARTON (0006-5086-01) / 30 PELLET in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength20MG/PACKET
Approval Date:Aug 30, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 5, 2030
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Regulatory Exclusivity Expiration:Nov 8, 2024
Regulatory Exclusivity Use:FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Regulatory Exclusivity Expiration:Aug 30, 2027
Regulatory Exclusivity Use:NEW PRODUCT

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