LIVTENCITY Drug Patent Profile
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When do Livtencity patents expire, and what generic alternatives are available?
Livtencity is a drug marketed by Takeda Pharms Usa and is included in one NDA. There is one patent protecting this drug.
The generic ingredient in LIVTENCITY is maribavir. One supplier is listed for this compound. Additional details are available on the maribavir profile page.
DrugPatentWatch® Generic Entry Outlook for Livtencity
Livtencity will be eligible for patent challenges on November 23, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 23, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for LIVTENCITY?
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- What is Average Wholesale Price for LIVTENCITY?
Summary for LIVTENCITY
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Patent Applications: | 633 |
| Drug Prices: | Drug price information for LIVTENCITY |
| What excipients (inactive ingredients) are in LIVTENCITY? | LIVTENCITY excipients list |
| DailyMed Link: | LIVTENCITY at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LIVTENCITY
Generic Entry Date for LIVTENCITY*:
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 NDA:
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.
Pharmacology for LIVTENCITY
US Patents and Regulatory Information for LIVTENCITY
LIVTENCITY is protected by one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LIVTENCITY is ⤷ Sign Up.
This potential generic entry date is based on 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.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting LIVTENCITY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE REFRACTORY TO TREATMENT WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR, OR FOSCARNET, WHERE THE PATIENT IS A STEM CELL, KIDNEY, OR LIVER TRANSPLANT RECIPIENT
FDA Regulatory Exclusivity protecting LIVTENCITY
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
| 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 LIVTENCITY
| 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 |
