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 Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug.
This drug has ninety-four 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: | 94 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| 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
*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 four 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
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
| 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 | ⤷ 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 | ⤷ Sign Up | ||||
| Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-001 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-001 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | TABLET;ORAL | 209939-001 | 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 | 209939-002 | 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 | TABLET;ORAL | 209939-001 | 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 |
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
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
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
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 |
|---|---|---|---|
| Tunisia | 2014000345 | PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE | ⤷ Sign Up |
| South Korea | 102149561 | ⤷ Sign Up | |
| European Patent Office | 1622880 | DIHYDROQUINAZOLINES SUBSTITUEES A PROPRIETES ANTIVIRALES (SUBSTITUTED DIHYDROCHINAZOLINES HAVING ANTIVIRAL PROPERTIES) | ⤷ Sign Up |
| Japan | 6387486 | ⤷ Sign Up | |
| Taiwan | I335912 | ⤷ Sign Up | |
| Brazil | PI0410029 | dihidroquinazolinas substituìdas | ⤷ 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 | LUC00070 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU71/17/1245 20180110 |
| 1622880 | C20180020 00265 | Estonia | ⤷ Sign Up | PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018 |
| 1622880 | 18C1029 | France | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR AINSI QUE SES SELS,SOLVATES ET SELS SOLVATES,PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/17/1245/001-004 20180110 |
| 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 | LUC00080 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110 |
| 1622880 | SPC/GB18/027 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR, OR ITS SALTS, SOLVATES OR SOLVATES OF THE SALTS; REGISTERED: UK EU/1/17/1245(NI) 20180110; UK PLGB 53095/0046 20180110; UK PLGB 53095/0047 20180110; UK PLGB 53095/0048 20180110; UK PLGB 53095/0049 20180110 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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