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Last Updated: June 27, 2022

Letermovir - Generic Drug Details


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What are the generic 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-three patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for letermovir
International Patents:83
US Patents:3
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 35
Clinical Trials: 16
Patent Applications: 265
What excipients (inactive ingredients) are in letermovir?letermovir excipients list
DailyMed Link:letermovir at DailyMed
Recent Clinical Trials for letermovir

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

SponsorPhase
Trellis Bioscience LLCPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Jean-Pierre RoutyN/A

See all letermovir clinical trials

US Patents and Regulatory Information 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-001 Nov 8, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme PREVYMIS letermovir SOLUTION;INTRAVENOUS 209940-002 Nov 8, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-001 Nov 8, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Poland 1622880 See Plans and Pricing
Poland 2819648 See Plans and Pricing
Morocco 27794 DIHYDROQUINAZOLINES SUBSTITUEES A PROPRIETES ANTIVIRALES See Plans and Pricing
Ukraine 111415 ФАРМАЦЕВТИЧНИЙ ПРЕПАРАТ, ЩО МІСТИТЬ ПОХІДНУ ДИГІДРОХІНАЗОЛІНУ З ПРОТИВІРУСНОЮ АКТИВНІСТЮ (PHARMACEUTICAL PREPARATION CONTAINING DIHYDROQUINAZOLINE DERIVATIVE POSSESSING ANTIVIRAL ACTIVITY) See Plans and Pricing
Honduras 2004000146 DIHIDROQUINAZOLINAS SUSTITUIDAS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for letermovir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 LUC00070 Luxembourg See Plans and Pricing PRODUCT NAME: LETERMOVIR; AUTHORISATION NUMBER AND DATE: EU71/17/1245 20180110
1622880 C01622880/01 Switzerland See Plans and Pricing FORMER OWNER: AICURIS ANTI-INFECTIVE CURES GMBH, DE
1622880 LUC00080 Luxembourg See Plans and Pricing PRODUCT NAME: LETERMOVIR, OU UN SEL, SOLVATE OU SOLVATE DE SON SEL; AUTHORISATION NUMBER AND DATE: /EU/1/17/1245 20180110
1622880 1890019-1 Sweden See Plans and Pricing PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110
1622880 C20180020 00265 Estonia See Plans and Pricing PRODUCT NAME: LETERMOVIIR;REG NO/DATE: EU/1/17/1245 10.01.2018
>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.