LETERMOVIR - Generic Drug Details
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What are the generic drug sources for letermovir and what is the scope of freedom to operate?
Letermovir
is the generic ingredient in one branded drug marketed by MSD and Merck Sharp Dohme, and is included in three NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Letermovir has ninety-seven patent family members in forty-seven countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for LETERMOVIR
International Patents: | 97 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 25 |
Patent Applications: | 270 |
What excipients (inactive ingredients) are in LETERMOVIR? | LETERMOVIR excipients list |
DailyMed Link: | LETERMOVIR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LETERMOVIR
Generic Entry Dates for LETERMOVIR*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
Generic Entry Dates for LETERMOVIR*:
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-]) Dosage:
TABLET;ORAL |
Generic Entry Dates for LETERMOVIR*:
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.
Recent Clinical Trials for LETERMOVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharp & Dohme LLC | Phase 2 |
University of Pennsylvania | Phase 2 |
Maimónides Biomedical Research Institute of Córdoba | Phase 2 |
Generic filers with tentative approvals for LETERMOVIR
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 480MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 240MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LETERMOVIR
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 | ⤷ 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 | TABLET;ORAL | 209939-001 | Nov 8, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | 209939-001 | Nov 8, 2017 | RX | Yes | No | ⤷ 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 | Y | ⤷ Sign Up | |||
Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-002 | 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 LETERMOVIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | 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 | 209940-001 | 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 |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LETERMOVIR
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 LETERMOVIR
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Honduras | 2004000146 | DIHIDROQUINAZOLINAS SUSTITUIDAS | ⤷ Sign Up |
Japan | 2006525249 | ⤷ Sign Up | |
Egypt | 25273 | Substituted dihydroquinazolines. | ⤷ Sign Up |
Portugal | 1622880 | ⤷ Sign Up | |
Cyprus | 1121910 | ⤷ Sign Up | |
Poland | 2819648 | ⤷ Sign Up | |
Lithuania | 3556350 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LETERMOVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1622880 | C20180020 00265 | Estonia | ⤷ Sign Up | PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018 |
1622880 | 327 50010-2018 | Slovakia | ⤷ Sign Up | OWNER(S): AIC246 GMBH&CO. KG, WUPPERTAL, DE; PREVIOUS OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, WUPPERTAL, DE; |
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 | 122018000080 | Germany | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR ODER DESSEN SALZ, SOLVAT ODER SOLVAT DES SALZES; REGISTRATION NO/DATE: EU/1/17/1245 20180108 |
1622880 | 2018/026 | Ireland | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE, OR SOLVATE OF ITS SALT.; REGISTRATION NO/DATE: EU/1/17/1245 20180108 |
1622880 | C 2018 027 | Romania | ⤷ Sign Up | PRODUCT NAME: LETERMOVIR SAU SAREA SA, SOLVATUL SAU, SAU SOLVATUL SARII SALE; NATIONAL AUTHORISATIONNUMBER: EU/1/17/1245; DATE OF NATIONAL AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EU ROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108 |
1622880 | C201830035 | Spain | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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