Details for New Drug Application (NDA): 219485
✉ Email this page to a colleague
NDA 219485 describes LIVMARLI, which is a drug marketed by Mirum and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the LIVMARLI profile page.
The generic ingredient in LIVMARLI is maralixibat chloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the maralixibat chloride profile page.
The generic ingredient in LIVMARLI is maralixibat chloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the maralixibat chloride profile page.
Summary for 219485
| Tradename: | LIVMARLI |
| Applicant: | Mirum |
| Ingredient: | maralixibat chloride |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219485
Generic Entry Date for 219485*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) 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: 219485
Suppliers and Packaging for NDA: 219485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIVMARLI | maralixibat chloride | TABLET;ORAL | 219485 | NDA | Mirum Pharmaceuticals Inc. | 79378-210 | 79378-210-30 | 1 BOTTLE in 1 CARTON (79378-210-30) / 30 TABLET in 1 BOTTLE |
| LIVMARLI | maralixibat chloride | TABLET;ORAL | 219485 | NDA | Mirum Pharmaceuticals Inc. | 79378-215 | 79378-215-30 | 1 BOTTLE in 1 CARTON (79378-215-30) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 10, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 26, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) WHO WEIGH 25 KILOGRAMS AND ABOVE | ||||||||
Complete Access Available with Subscription
