Details for New Drug Application (NDA): 215596
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NDA 215596 describes LIVTENCITY, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the LIVTENCITY profile page.
The generic ingredient in LIVTENCITY is maribavir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the maribavir profile page.
The generic ingredient in LIVTENCITY is maribavir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the maribavir profile page.
Summary for 215596
| Tradename: | LIVTENCITY |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | maribavir |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215596
Generic Entry Date for 215596*:
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.
Pharmacology for NDA: 215596
Suppliers and Packaging for NDA: 215596
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIVTENCITY | maribavir | TABLET;ORAL | 215596 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-800 | 64764-800-28 | 1 BOTTLE in 1 CARTON (64764-800-28) / 28 TABLET, COATED in 1 BOTTLE |
| LIVTENCITY | maribavir | TABLET;ORAL | 215596 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-800 | 64764-800-56 | 1 BOTTLE in 1 CARTON (64764-800-56) / 56 TABLET, COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 23, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 23, 2028 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | Nov 23, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 4, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
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