Case	Court	Filed	Status	Judge
Allergan Holdings Unlimited Company et al v. MSN Laboratories Private Limited et al 1:2023cv00794	D. Del.	2023-07-21	Terminated 2025-08-25	—
Allergan USA, Inc. et al v. Sun Pharmaceutical Industries Limited 1:2022cv00182	D. Del.	2022-02-09	Terminated 2023-10-12	—
Allergan USA, Inc. et al v. MSN Laboratories Private Limited et al 1:2022cv00181	D. Del.	2022-02-09	Terminated 2023-10-12	—
Allergan USA, Inc. et al v. MSN Laboratories Private Limited et al 1:2021cv01064	D. Del.	2021-07-23	Terminated 2023-10-12	—
Allergan USA, Inc. et al v. Zydus Pharmaceuticals (USA) Inc. 1:2021cv01066	D. Del.	2021-07-23	Terminated 2022-02-09	—
Allergan USA, Inc. et al v. Hetero Labs Limited et al 1:2021cv01063 4 patentsANDA 213427eluxadoline	D. Del.	2021-07-23	Terminated 2021-10-20	—
Allergan USA, Inc. et al v. Alkem Laboratories Limited 1:2021cv01061	D. Del.	2021-07-23	Terminated 2021-10-18	—
Allergan USA, Inc. et al v. Aurobindo Pharma Ltd. et al 1:2021cv01062	D. Del.	2021-07-23	Terminated 2022-02-09	—
Allergan USA, Inc. et al v. Sun Pharmaceutical Industries Limited 1:2021cv01065	D. Del.	2021-07-23	Terminated 2023-10-12	—
Allergan USA, Inc. et al v. Sun Pharmaceutical Industries Ltd. 1:2020cv01479 3 patentsANDA 213447eluxadoline	D. Del.	2020-10-29	Terminated 2023-10-12	—
Allergan USA, Inc. et al v. Hetero Labs Limited et al 1:2020cv01344	D. Del.	2020-10-05	Terminated 2021-10-20	—
Allergan USA, Inc., et al. v. MSN Laboratories Private Limited, et al. 1:2019cv01727 6 patentsANDA 213511, 213613, 213427, 213576, 213447, 213522eluxadoline	D. Del.	2019-09-13	Terminated 2025-01-02	—
Allergan USA, Inc. et al v. Aurobindo Pharma Ltd. et al 1:2019cv01674 8 patentsANDA 213511eluxadoline	D. Del.	2019-09-06	Terminated 2022-02-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Allergan Holdings Unlimited Company FDA-2019-P-2537 · 6 docket documents Allergan Holdings Unlimited Company filed this citizen petition under 21 U.S.C. § 355 requesting that FDA publish updated guidance requiring clinical endpoint testing for generic versions of VIBERZI (eluxadoline) tablets, refuse to receive or approve any abbreviated new drug application (ANDA) refer	505(q)	2019-05-24	Withdrawn	Allergan Holdings Unlimited Company

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

8 trials from ClinicalTrials.gov — 1 recruiting, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children NCT03339128	Phase 2	Recruiting	AbbVie	95	2017-11-15 → 2026-12
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)NCT01553747	Phase 3	Completed	Furiex Pharmaceuticals, Inc	1,146	2012-05-29 → 2014-01-09
Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use NCT02959983	Phase 4	Completed	Allergan	346	2016-10-25 → 2018-01-22
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)NCT01553591	Phase 3	Completed	Furiex Pharmaceuticals, Inc	1,282	2012-05-29 → 2014-07-29
Eluxadoline Bile Acid Malabsorption (BAM) Study NCT03441581	Phase 4	Completed	Allergan	24	2018-02-23 → 2020-04-28
Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea NCT01130272	Phase 2	Completed	Furiex Pharmaceuticals, Inc	807	2010-04-28 → 2011-07-14
Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence NCT03489265	Phase 2	Withdrawn	University of North Carolina, Chapel Hill	—	2019-04 → 2020-03
Investigation of Eluxadoline for Diabetic Diarrhea NCT04313088	Phase 2/3	Withdrawn	Temple University	—	2022-07-01 → 2024-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$28.12

per ea

Lowest NADAC/Unit

$28.11

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61874007560VIBERZI 75 MG TABLET	$28.12	EA	Brand	—	2026-06-17
61874010060VIBERZI 100 MG TABLET	$28.11	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1214.86

Highest Price

$1520.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61874-0100-60VIBERZI 100MG TAB, ORAL	$1520.82	FSS	Abbvie US LLC	07/31/2030
61874-0100-60VIBERZI 100MG TAB, ORAL	$1214.86	Big4	Abbvie US LLC	07/31/2030
61874-0075-60VIBERZI 75MG TAB, ORAL	$1520.82	FSS	Abbvie US LLC	07/31/2030
61874-0075-60VIBERZI 75MG TAB, ORAL	$1215.33	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Viberzi (2024)

Total Spending

$59.2M

Total Claims

34,827

Beneficiaries

6,935

Avg Cost/Unit

$26.18

Spending Trend

$60.1M(2019)→$60.2M(2020)→$58.1M(2021)→$59.2M(2022)→$59.7M(2023)→$59.2M(2024)

YoY Change:-0.3%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDELUXADOLINE

DMF 321482017

ALKEM LABORATORIES LTDELUXADOLINE

DMF 333722019

HONOUR LAB LTDELUXADOLINE

DMF 333842018

SUN PHARMACEUTICAL INDUSTRIES LTDELUXADOLINE

DMF 335682019

APITORIA PHARMA PRIVATE LTDELUXADOLINE

DMF 335902019

LEE PHARMA LTDELUXADOLINE

DMF 424682025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 19, 2020	SUPPL -7	View Letter (PDF)
Jul 6, 2018	SUPPL -6	View Letter (PDF)
Apr 16, 2018	SUPPL -3	View Letter (PDF)
Nov 13, 2017	SUPPL -5	View Letter (PDF)
Apr 21, 2017	SUPPL -2	View Letter (PDF)
Feb 12, 2016	SUPPL -1	View Letter (PDF)
May 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 75MG

RLDAB

13 patents0 exclusivities▴

TABLET;ORAL | Approved: May 27, 2015

Patents (13) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7741356	May 27, 2029	—	Yes	Yes	—	—
8691860	Jul 7, 2028	—	Yes	—		—
9115091	Jul 7, 2028	—	Yes	Yes		—
9364489	Jul 7, 2028	—	—	—		—
9675587	Mar 14, 2033	—	—	Yes	—	—
9789125	Jul 7, 2028	—	—	Yes		—
10188632	Mar 14, 2033	—	—	Yes	—	—
11007179	Mar 14, 2033	—	—	Yes	—	—
11090291	Mar 14, 2033	—	—	Yes	—	—
11160792	Mar 14, 2033	—	—	Yes	—	—
11229627	Mar 14, 2033	—	—	Yes	—	—
11311516	Mar 14, 2033	—	—	Yes	—	—
12097187	Mar 14, 2033	—	—	—		—

#002 — 100MG

RLDAB

13 patents0 exclusivities▾

TABLET;ORAL | Approved: May 27, 2015