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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 209940


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NDA 209940 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 209940
Tradename:PREVYMIS
Applicant:Merck Sharp Dohme
Ingredient:letermovir
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209940
Generic Entry Date for 209940*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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 LLC 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 LLC 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:Aug 2, 2026
Regulatory Exclusivity Use:EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE
Regulatory Exclusivity Expiration:Jun 5, 2030
Regulatory Exclusivity Use:FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
Regulatory Exclusivity Expiration:Aug 30, 2027
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 209940

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.