Details for New Drug Application (NDA): 022231
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NDA 022231 describes TERLIVAZ, which is a drug marketed by Mallinckrodt Ireland and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TERLIVAZ profile page.
The generic ingredient in TERLIVAZ is terlipressin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the terlipressin acetate profile page.
The generic ingredient in TERLIVAZ is terlipressin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the terlipressin acetate profile page.
Summary for 022231
| Tradename: | TERLIVAZ |
| Applicant: | Mallinckrodt Ireland |
| Ingredient: | terlipressin acetate |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022231
Generic Entry Date for 022231*:
Constraining patent/regulatory exclusivity:
TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION Dosage:
POWDER;INTRAVENOUS |
*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: 022231
| Mechanism of Action | Vasopressin Receptor Agonists |
Suppliers and Packaging for NDA: 022231
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERLIVAZ | terlipressin acetate | POWDER;INTRAVENOUS | 022231 | NDA | Mallinckrodt Hospital Products Inc. | 43825-200 | 43825-200-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 0.85MG BASE/VIAL | ||||
| Approval Date: | Sep 14, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 14, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 14, 2029 | ||||||||
| Regulatory Exclusivity Use: | TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 5, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION | ||||||||
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