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 Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Letermovir has eighty-seven patent family members in forty-six countries.
One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for LETERMOVIR
International Patents: | 87 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 21 |
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 |
*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 |
---|---|
Children's Oncology Group | Phase 3 |
Merck Sharp & Dohme LLC | Phase 3 |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 |
Generic filers with tentative approvals for LETERMOVIR
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 480MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-002 | Nov 8, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
---|---|---|---|
New Zealand | 543317 | Substituted dihydrochinazolines having antiviral properties | ⤷ Try a Trial |
Mexico | 2014010364 | COMPOSICION FARMACEUTICA QUE CONTIENE UN DERIVADO DE DIHIDROQUINAZOLINA ANTIVIRALMENTE ACTIVO. (PHARMACEUTICAL PREPARATION CONTAINING AN ANTIVIRALLY ACTIVE DIHYDROQUINAZOLINE DERIVATIVE.) | ⤷ Try a Trial |
Colombia | 5700764 | DIHIDROQUINAZOLINAS SUSTITUIDAS CON PROPIEDADES ANTIVIRALES | ⤷ Try a Trial |
Brazil | 112014020946 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LETERMOVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1622880 | 2018C/015 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU/1/17/1245 20180110 |
1622880 | C201830035 | Spain | ⤷ Try a 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 | C01622880/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, DE |
1622880 | C20180020 00265 | Estonia | ⤷ Try a Trial | PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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