MARIBAVIR - Generic Drug Details

What are the generic drug 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:	14
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

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

Sponsor	Phase
Takeda Development Center Americas, Inc.	Phase 1
Takeda	Phase 1
Columbia University	Phase 1

See all MARIBAVIR clinical trials

Pharmacology for MARIBAVIR

Drug Class	Cytomegalovirus pUL97 Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors Cytomegalovirus pUL97 Kinase Inhibitors P-Glycoprotein Inhibitors

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
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes
Takeda Pharms Usa	LIVTENCITY	maribavir	TABLET;ORAL	215596-001	Nov 23, 2021		RX	Yes	Yes

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