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
Sponsor | Phase |
---|---|
Medical University of South Carolina | Phase 4 |
Takeda | Phase 4 |
Takeda Development Center Americas, Inc. | Phase 1 |
Pharmacology 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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