Prescription medicine

Linerixibat Brand names: Lynavoy

Linerixibat (Lynavoy) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the linerixibat FDA label on DailyMed (effective July 29, 2026, Intercept Pharmaceuticals Inc); the NDA 220295 record on Drugs@FDA; every linerixibat label on DailyMed.

Highlights of the record

FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.

Forms and strengths

40 mg

Film-coated tablet.

On the market

Earliest approval on file: March 17, 2026 Lynavoy, Intercept; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: September 6, 2031 Lynavoy tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is linerixibat used for?

From the label: indications and usage
LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3) ]. LYNAVOY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. […]

FDA pharmacologic class: Ileal Bile Acid Transporter Inhibitor.

Source: FDA drug label (Lynavoy), Intercept Pharmaceuticals Inc, effective July 29, 2026 (SPL set c00317c8-709c-4707-a6d1-632bff123026), via openFDA; the full label on DailyMed

Is there a generic for linerixibat (Lynavoy)?

No generic linerixibat is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Lynavoy tablets: the compound patent runs to September 6, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2026 earliest approval on file
2031 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Other ileal bile acid transporter inhibitors: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other