Details for New Drug Application (NDA): 214662
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NDA 214662 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 214662
| Tradename: | LIVMARLI |
| Applicant: | Mirum |
| Ingredient: | maralixibat chloride |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214662
Generic Entry Date for 214662*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) Dosage:
SOLUTION;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: 214662
Suppliers and Packaging for NDA: 214662
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662 | NDA | Mirum Pharmaceuticals Inc. | 79378-110 | 79378-110-01 | 1 BOTTLE in 1 CARTON (79378-110-01) / 30 mL in 1 BOTTLE |
| LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662 | NDA | Mirum Pharmaceuticals Inc. | 79378-111 | 79378-111-01 | 1 BOTTLE in 1 CARTON (79378-111-01) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 9.5MG BASE/ML | ||||
| Approval Date: | Sep 29, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 29, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) 1 YEAR OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Sep 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 13, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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