Generic Terlivaz Availability
Last updated on Apr 10, 2025.
Terlivaz is a brand name of terlipressin, approved by the FDA in the following formulation(s):
TERLIVAZ (terlipressin acetate - powder;intravenous)
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Manufacturer: MALLINCKRODT IRELAND
Approval date: September 14, 2022
Strength(s): EQ 0.85MG BASE/VIAL [RLD]
Is there a generic version of Terlivaz available?
No. There is currently no therapeutically equivalent version of Terlivaz available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Terlivaz. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Method of treating patients with hepatorenal syndrome type 1
Patent 10,335,452
Issued: July 2, 2019
Inventor(s): Jamil Khurram & Pappas Stephen Chris & Potenziano Jim
Assignee(s): Mallinckrodt Hospital Products IP LimitedThe principles and embodiments of the present disclosure relate to methods for using terlipressin to treat a patient having impaired renal function associated with liver disease. A patient identified as suffering from HRS-1 is tested to determine if the patient meets at least two out of three criteria, wherein the three criteria include a WBC<4 or >12 cells/μL; HR>90 bpm; and any one of HCO<21 mmol/L or PaCO<32 mmHg or >20 breaths per minute. If the patient meets at least two of the criteria, he or she is administered terlipressin in an amount effective to produce a reduction in serum creatinine of at least 1.0 mg/dL.
Patent expiration dates:
- April 5, 2037✓
- April 5, 2037
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- September 14, 2027 - NEW CHEMICAL ENTITY
- September 14, 2029 - TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION
More about Terlivaz (terlipressin)
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
