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Last Updated: November 12, 2019

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PREVYMIS Drug Profile

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When do Prevymis patents expire, and what generic alternatives are available?

Prevymis is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are two patents protecting this drug.

This drug has forty-four patent family members in thirty-six countries.

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 PREVYMIS
Drug patent expirations by year for PREVYMIS
Drug Prices for PREVYMIS

See drug prices for PREVYMIS

Generic Entry Opportunity Date for PREVYMIS
Generic Entry Dates for PREVYMIS*:
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)
NDA:
Dosage:
SOLUTION;IV (INFUSION)
Generic Entry Dates for PREVYMIS*:
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)
NDA:
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.

Recent Clinical Trials for PREVYMIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
City of Hope Medical CenterPhase 2
National Cancer Institute (NCI)Phase 2
Dana-Farber Cancer InstitutePhase 2

See all PREVYMIS clinical trials

Synonyms for PREVYMIS
(S)-[8-fluoro-2-[4-(3-methoxyphenyl)piperazine-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydroquinazoline-4-yl]acetic acid
(S)-{8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydro-quinazolin-4-yl}acetic acid
(S)-{8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydroquinazolin-4-yl}acetic acid
(S)-{8-fluoro-2-[4-(3-methoxyphenyl)piperazine-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydroquinazoline-4-yl}acetic acid
(S)-2-(8-fluoro-3-(2-methoxy-5-(trifluoromethyl)phenyl)-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3,4-dihydroquinazolin-4-yl)acetic acid
1H09Y5WO1F
2-((4S)-8-Fluoro-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-4H-quinazolin-4-yl)acetic acid
2-[(4S)-8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4H-quinazolin-4-yl]acetic acid
4-Quinazolineacetic acid, 8-fluoro-3,4-dihydro-2-(4-(3-methoxyphenyl)-1-piperazinyl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-, (4S)-
917389-32-3
AIC 246
AIC-246
AIC246
AIC246;AIC 246;AIC-246
AKOS030526995
CHEMBL1241951
CS-1571
D10801
DB12070
DTXSID40238683
EX-A1871
FWYSMLBETOMXAG-QHCPKHFHSA-N
HY-15233
J3.556.145E
Letermovir
Letermovir (JAN/USAN/INN)
Letermovir [USAN:INN]
NCGC00378936-01
Prevymis (TN)
SB16739
SCHEMBL379403
UNII-1H09Y5WO1F
ZINC100369359

US Patents and Regulatory Information for PREVYMIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PREVYMIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 C201830035 Spain   Start Trial PRODUCT NAME: LETERMOVIR, SUS SALES Y SOLVATOS, Y SOLVATOS DE LAS SALES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1245; DATE OF AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108
1622880 C20180020 00265 Estonia   Start Trial PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018
1622880 2018C/015 Belgium   Start Trial PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU/1/17/1245 20180110
1622880 CA 2018 00026 Denmark   Start Trial PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110
1622880 LUC00080 Luxembourg   Start Trial PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110
1622880 LUC00070 Luxembourg   Start Trial PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU71/17/1245 20180110
1622880 CR 2018 00026 Denmark   Start Trial PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
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Merck

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