prevymis Drug Patent Profile
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Which patents cover Prevymis, and when can generic versions of Prevymis launch?
Prevymis is a drug marketed by MSD and Merck Sharp Dohme and is included in three NDAs. There are three patents protecting this drug.
This drug has ninety-seven patent family members in forty-seven countries.
The generic ingredient in PREVYMIS is letermovir. One supplier is listed for this compound. Additional details are available on the letermovir profile page.
DrugPatentWatch® Generic Entry Outlook for Prevymis
Prevymis was eligible for patent challenges on November 8, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 5, 2030. This may change due to patent challenges or generic licensing.
There is one tentative approval for the generic drug (letermovir), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for prevymis
International Patents: | 97 |
US Patents: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 7 |
Patent Applications: | 98 |
Drug Prices: | Drug price information for prevymis |
What excipients (inactive ingredients) are in prevymis? | prevymis excipients list |
DailyMed Link: | prevymis at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for prevymis
Generic Entry Dates for prevymis*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for prevymis*:
Constraining patent/regulatory exclusivity:
FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) NDA:
Dosage:
TABLET;ORAL |
Generic Entry Dates for prevymis*:
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) NDA:
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.
Recent Clinical Trials for prevymis
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Oncology Group | Phase 3 |
Jean-Pierre Routy | N/A |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
Pharmacology for prevymis
US Patents and Regulatory Information for prevymis
prevymis is protected by three US patents and eight FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of prevymis is ⤷ Sign Up.
This potential generic entry date is based on FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting prevymis
Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted dihydroquinazolines
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted dihydroquinazolines
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting prevymis
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)
Exclusivity Expiration: ⤷ Sign Up
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)
Exclusivity Expiration: ⤷ Sign Up
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
Exclusivity Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
Exclusivity Expiration: ⤷ Sign Up
PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-])
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
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 | TABLET;ORAL | 209939-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-001 | Nov 8, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for prevymis
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | TABLET;ORAL | 209939-001 | Nov 8, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for prevymis
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merck Sharp & Dohme B.V. | Prevymis | letermovir | EMEA/H/C/004536 Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Consideration should be given to official guidance on the appropriate use of antiviral agents. |
Authorised | no | no | yes | 2018-01-08 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for prevymis
When does loss-of-exclusivity occur for prevymis?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13224947
Patent: Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014020946
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 65203
Patent: PREPARATION PHARMACEUTIQUE CONTENANT UN DERIVE DE DIHYDROCHINAZOLINE A ACTION ANTIVIRALE (PHARMACEUTICAL COMPOSITION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14002306
Patent: Una composicion farmaceutica intravenosa que comprende al compuesto acido {8-fluoro-2-[4-(3-metoxifenil)-piperazina-1-il]-3-[2-metoxi-5-(trifluorometil)fenil]-3,4-dihidroquinazolina-4-il}acetico, al menos un excipiente seleccionado de ciclodextrinas, lisina y arginina, y agua; su metodo de preparacion; y su uso para el tratamiento y/o profilaxis de infecciones por virus.
Estimated Expiration: ⤷ Sign Up
China
Patent: 4144678
Patent: Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative
Estimated Expiration: ⤷ Sign Up
Patent: 0433166
Patent: 含有抗病毒活性二氢喹唑啉衍生物的药物制剂 (Pharmaceutical preparation containing antivirally active dihydroquinazoline derivative)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 61076
Patent: Composición farmacéutica que contiene un derivado de dihidroquinazolina antiviralmente activo
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0191369
Estimated Expiration: ⤷ Sign Up
Patent: 0240197
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 21910
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 19648
Estimated Expiration: ⤷ Sign Up
Patent: 56350
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6584
Patent: ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ ПРОИЗВОДНОЕ ДИГИДРОХИНАЗОЛИНА С ПРОТИВОВИРУСНОЙ АКТИВНОСТЬЮ (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Patent: 1400963
Patent: ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ ПРОИЗВОДНОЕ ДИГИДРОХИНАЗОЛИНА С ПРОТИВОВИРУСНОЙ АКТИВНОСТЬЮ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19648
Patent: PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Patent: 56350
Patent: PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE AVEC UNE CONFIGURATION DE "S" A LA POSITION 4 (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE WITH S CONFIGURATION IN POSITION 4)
Estimated Expiration: ⤷ Sign Up
Patent: 28218
Patent: PRÉPARATION PHARMACEUTIQUE COMPRENANT UNE DÉRIVÉ ANTIVIRALE DE DIHYDROQUINAZOLINE (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 56350
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2012101680
Patent: Pharmazeutische Zubereitung enthaltend ein antiviral wirksames Dihydrochinazolinderivat
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 05462
Patent: 含有抗病毒活性二氫喹唑啉衍生物的藥物製劑 (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 45949
Estimated Expiration: ⤷ Sign Up
Patent: 65553
Estimated Expiration: ⤷ Sign Up
India
Patent: 92MUN2014
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4363
Patent: תכשיר רוקחות המכיל נגזרת דיהידרוקוינאזולין עם פעילות אנטי-נגיפית (Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 87486
Estimated Expiration: ⤷ Sign Up
Patent: 15508801
Patent: 抗ウイルス活性ジヒドロキナゾリン誘導体を含有する医薬組成物
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 19648
Estimated Expiration: ⤷ Sign Up
Patent: 56350
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 2310
Patent: PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 9666
Patent: COMPOSICION FARMACEUTICA QUE CONTIENE UN DERIVADO DE DIHIDROQUINAZOLINA ANTIVIRALMENTE ACTIVO. (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE.)
Estimated Expiration: ⤷ Sign Up
Patent: 14010364
Patent: COMPOSICION FARMACEUTICA QUE CONTIENE UN DERIVADO DE DIHIDROQUINAZOLINA ANTIVIRALMENTE ACTIVO. (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 448
Patent: FARMACEUTSKI PREPARAT КОЈI OBUHVATA ANTIVIRUSNO EFIKASAN DERIVAT DIHIDROHINAZOLINA (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 941
Patent: Préparation pharmaceutique contenant un dérivé de dihydrochinazoline à action antivirale
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8444
Patent: Pharmaceutical preparation containing an antivirally active dihydroquinazoline derivative
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 014501937
Patent: PHARMACEUTICAL COMPOSITION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 19648
Estimated Expiration: ⤷ Sign Up
Patent: 56350
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 19648
Estimated Expiration: ⤷ Sign Up
Patent: 56350
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 157
Patent: FARMACEUTSKI PREPARAT KOJI OBUHVATA ANTIVIRUSNO EFIKASAN DERIVAT DIHIDROHINAZOLINA (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Patent: 137
Patent: FARMACEUTSKI PREPARAT KOJI OBUHVATA ANTIVIRUSNO EFIKASAN DERIVAT DIHIDROHINAZOLINA SA S KONFIGURACIJOM U POLOŽAJU 4 (PHARMACEUTICAL PREPARATION COMPRISING AN ANTIVIRAL DIHYDROQUINAZOLINE DERIVATIVE WITH S CONFIGURATION IN POSITION 4)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201405294X
Patent: PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 19648
Estimated Expiration: ⤷ Sign Up
Patent: 56350
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1405949
Patent: PHARMACEUTICAL PREPARATION CONTAINING AND ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2149561
Estimated Expiration: ⤷ Sign Up
Patent: 140130683
Patent: PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 41698
Estimated Expiration: ⤷ Sign Up
Patent: 72133
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 14000345
Patent: PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1415
Patent: ФАРМАЦЕВТИЧНИЙ ПРЕПАРАТ, ЩО МІСТИТЬ ПОХІДНУ ДИГІДРОХІНАЗОЛІНУ З ПРОТИВІРУСНОЮ АКТИВНІСТЮ (PHARMACEUTICAL PREPARATION CONTAINING DIHYDROQUINAZOLINE DERIVATIVE POSSESSING ANTIVIRAL ACTIVITY)
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering prevymis around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2004096778 | ⤷ Sign Up | |
Morocco | 35941 | Préparation pharmaceutique contenant un dérivé de dihydrochinazoline à action antivirale | ⤷ Sign Up |
Hungary | S1800018 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for prevymis
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1622880 | 697 | Finland | ⤷ Sign Up | |
1622880 | CA 2018 00026 | Denmark | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110 |
1622880 | 327 50010-2018 | Slovakia | ⤷ Sign Up | OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE; |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |