Obeticholic Acid

Sold as Ocaliva. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 15, 2026, FDA lists 5 applications for Obeticholic Acid (sold as Ocaliva), first approved May 27, 2016, with 0 new uses approved and 0 published complete response letters.

First approved: May 27, 2016
Applications: 5
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $120M
First approved in the EU: Dec 12, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Ocaliva	Part D	$120M	-35%	1,745

FDA Drug Safety Communications

2 communications since 2020 that name this drug; see all communications

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of primary biliary cirrhosisIntercept Pharmaceuticals, Inc. · designated Apr 9, 2008 · approved May 27, 2016

Approvals in the EU (EMA)

First approved in the EU 7 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ocaliva, new substanceAdvanz Pharma Limited · Dec 12, 2016 · revoked

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler OutcomesHepatitis B Virus, Steatosis · Assiut University	Phase 3	Not yet recruiting	Nov 15, 2024
Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic SteatohepatitisNon-alcoholic Steatohepatitis · Tanta University	Phase 2	Active, not recruiting	Oct 10, 2022
Obeticholic Acid for Prevention in Barrett's EsophagusBarrett Esophagus, Esophageal Adenocarcinoma · National Cancer Institute (NCI)	Phase 2	Recruiting	Jun 25, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


May 27, 2016	OcalivaNDA 207999 · New molecular entity	Intercept	4	Discontinued
May 30, 2023	Obeticholic AcidANDA 214862	Apotex	0	Discontinued
May 30, 2023	Obeticholic AcidANDA 214980	Lupin	0	Discontinued
May 30, 2023	Obeticholic AcidANDA 215017	Msn	0	Discontinued
—	Obeticholic AcidANDA 214935	Optimus Pharma Private Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA