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Last Updated: November 8, 2024

Maribavir - Generic Drug Details


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What are the generic sources for maribavir and what is the scope of patent protection?

Maribavir is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for maribavir
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 57
Clinical Trials: 15
Patent Applications: 2,807
What excipients (inactive ingredients) are in maribavir?maribavir excipients list
DailyMed Link:maribavir at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for maribavir
Generic Entry Date for maribavir*:
Constraining patent/regulatory exclusivity:
FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS (12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG) WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE THAT IS REFRACTORY TO TREATMENT (WITH OR WITHOUT GENOTYPIC RESISTANCE) WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET
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 maribavir

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

SponsorPhase
Medical University of South CarolinaPhase 4
TakedaPhase 4
Takeda Development Center Americas, Inc.Phase 1

See all maribavir clinical trials

US Patents and Regulatory Information for maribavir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa LIVTENCITY maribavir TABLET;ORAL 215596-001 Nov 23, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa LIVTENCITY maribavir TABLET;ORAL 215596-001 Nov 23, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa LIVTENCITY maribavir TABLET;ORAL 215596-001 Nov 23, 2021 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

EU/EMA Drug Approvals for maribavir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Livtencity maribavir EMEA/H/C/005787
LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).Consideration should be given to official guidance on the appropriate use of antiviral agents.
Authorised no no yes 2022-11-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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