Viewing data from:

LYNAVOY

NDA

LINERIXIBAT | N220295 | INTERCEPT PHARMACEUTICALS INC

1 strength1 unique patent2 unique exclusivities

Patent Timeline

1 unique patent, 2 exclusivities by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

9040518

Sep. 6, 2031

NCE

Mar. 17, 2031

ODE-517

Mar. 17, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Linerixibat Long-term Safety, and Tolerability Study NCT04167358	Phase 3	Active	GlaxoSmithKline	242	2020-07-14 → 2026-09-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 19, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

RLD

1 patent2 exclusivities▴

TABLET;ORAL | Approved: Mar 17, 2026

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9040518	Sep 6, 2031	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Mar 17, 2031	Active
ODE-517	Mar 17, 2033	Active

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

INTERCEPT PHARMACEUTICALS INC replaced GLAXOSMITHKLINE LLC as the listed applicant for LYNAVOY (linerixibat) NDA 220295.

Old: GLAXOSMITHKLINE LLC

New: INTERCEPT PHARMACEUTICALS INC

MODIFIEDApplicant7/1/2026

Applicant for linerixibat (LYNAVOY, NDA 220295) changed from GlaxoSmithKline to Intercept Pharmaceuticals.

Old: GLAXOSMITHKLINE

New: INTERCEPT