ELUXADOLINE - Generic Drug Details

What are the generic sources for eluxadoline and what is the scope of patent protection?

Eluxadoline is the generic ingredient in two branded drugs marketed by Zydus Pharms and Abbvie, and is included in two NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eluxadoline has one hundred and fifty-three patent family members in forty countries.

There are two drug master file entries for eluxadoline. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for ELUXADOLINE

International Patents:	153
US Patents:	21
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELUXADOLINE
What excipients (inactive ingredients) are in ELUXADOLINE?	ELUXADOLINE excipients list
DailyMed Link:	ELUXADOLINE at DailyMed

Recent Clinical Trials for ELUXADOLINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Devintec Sagl	NA
Allergan	Phase 3
Temple University	Phase 2/Phase 3

See all ELUXADOLINE clinical trials

Generic filers with tentative approvals for ELUXADOLINE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		75MG	TABLET;ORAL
		100MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ELUXADOLINE

Drug Class	mu-Opioid Receptor Agonist
Mechanism of Action	Opioid mu-Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ELUXADOLINE

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ELUXADOLINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIBERZI	Tablets	eluxadoline	75 mg and 100 mg	206940	6	2019-05-28

US Patents and Regulatory Information for ELUXADOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	8,609,709			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	11,007,179		Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	9,364,489
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	12,097,187
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	9,205,076

Expired US Patents for ELUXADOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	10,213,415
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	8,772,325
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	7,786,158
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	10,213,415
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	8,772,325

EU/EMA Drug Approvals for ELUXADOLINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Allergan Pharmaceuticals International Limited	Truberzi	eluxadoline	EMEA/H/C/004098Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).	Withdrawn	no	no	no	2016-09-19

International Patents for ELUXADOLINE

Country	Patent Number	Title	Estimated Expiration
Denmark	3112352
Israel	241561	פורמולציה למינון מאפנן קולטן אופיאויד (Opioid receptor modulator dosage formulations)
China	105228629	Opioid receptor modulator dosage formulations
Portugal	2573068
Poland	1725537

Supplementary Protection Certificates for ELUXADOLINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	CR 2017 00008	Denmark		PRODUCT NAME: ELUXADOLIN ELLER EN FARMACEUTISK ACCEPTABEL ENANTIOMER, DIASTEREOMER, RACEMAT ELLER SALT DERAF; REG. NO/DATE: EU/1/16/1126 20160921
1725537	132017000028006	Italy		PRODUCT NAME: ELUXADOLINE O UN ENANTIOMERO, DIASTEREOMERO, RACEMATO FARMACEUTICAMENTE ACCETTABILE O SALI DELLO STESSO(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921
1725537	2017C/003	Belgium		PRODUCT NAME: ELUXADOLINE OF EEN FARMACEUTISCH AANVAARDBAAR ENANTIOMEER, DIASTEREOMEER, RACEMAAT OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU1/16/1126 20160921
1725537	LUC00007	Luxembourg		PRODUCT NAME: ELUXADOLINE OU UN ENANTIOMERE, UN DIASTEREOMERE, UNRACEMATE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/16/1126 20160921
1725537	C20170005 00225	Estonia		PRODUCT NAME: ELUKSADOLIIN;REG NO/DATE: EU/1/16/1126 21.09.2016

Market Dynamics and Financial Trajectory for Eluxadoline

Last updated: July 28, 2025

Introduction

Eluxadoline, marketed under the brand name Viberzi, represents a significant therapeutic agent in the management of irritable bowel syndrome with diarrhea (IBS-D). Since its approval by the U.S. Food and Drug Administration (FDA) in 2015, the drug has garnered attention from pharmaceutical companies, healthcare providers, and investors navigating a complex landscape shaped by evolving clinical needs, regulatory standards, competitive pressures, and market opportunities. A comprehensive analysis of eluxadoline's market dynamics and financial trajectory reveals key factors influencing its commercial potential and strategic positioning within the gastrointestinal (GI) pharmacotherapy domain.

Pharmacological Profile and Clinical Utility

Eluxadoline is a mixed mu-opioid receptor and kappa-opioid receptor modulator designed to regulate bowel motility and visceral sensation in IBS-D. Its dual mechanism offers symptomatic relief with the potential to reduce diarrhea frequency and improve patient quality of life. Clinical trials demonstrated that eluxadoline significantly diminished abdominal pain and bowel movement frequency in IBS-D patients, positioning it as a targeted therapy in a niche market with unmet medical needs [1].

The drug's efficacy, however, is accompanied by safety considerations, including restrictions related to patients with a history of pancreatitis and those without a gallbladder. These factors influence its prescribing patterns, reimbursement landscape, and ultimately its market penetration.

Market Dynamics

1. Market Size and Growth Potential

The global IBS market was valued at approximately USD 1.2 billion in 2022, with IBS-D constituting a substantial segment due to its prevalence and symptom severity [2]. The IBS-D segment's growth is driven by increased awareness, rising diagnosis rates, and unmet treatment needs, particularly among women aged 18–45.

Eluxadoline’s peak sales potential hinges on its ability to capture a significant portion of this segment. Analysts project the IBS-D drug market could reach USD 2.5 billion by 2030, assuming an annual growth rate of approximately 8%. Key drivers include expanding diagnosis, patient adherence, and overcoming current limitations in treatment options.

2. Competitive Landscape

Eluxadoline faces competition from several pharmacological classes:

• Serotonergic agents: such as alosetron, indicated for severe IBS-D, though limited by safety concerns.
• Antispasmodics and antidiarrheal agents: including loperamide and hyoscine, which offer symptomatic relief but lack targeted mechanisms.
• Emerging therapeutics: including neuromodulators and novel biologics under development.

The competitive advantage of eluxadoline resides in its targeted mechanism, demonstrated efficacy, and tolerability profile, but its market share is constrained by safety warnings and formulary restrictions.

3. Regulatory and Safety Considerations

Regulatory bodies have imposed black box warnings due to risks of pancreatitis, especially in high-risk subgroups. These safety concerns impact prescribing patterns, limit patient eligibility, and influence drug positioning strategies. Ongoing pharmacovigilance and post-marketing surveillance are critical to maintaining regulatory approval and favorable market access.

4. Reimbursement and Pricing Strategies

Pricing strategies for eluxadoline vary across regions, influenced by healthcare systems, insurance coverage, and competitive pricing. In the United States, the drug's list price initially hovered around USD 8,000–USD 9,000 annually. Payers demanding value-based assessments pressure manufacturers to demonstrate cost-effectiveness, potentially impacting revenue streams.

5. Patent Status and Market Exclusivity

Eluxadoline’s initial patent protection provided exclusivity through 2024, barring biosimilar or generic competition. Patent expiry would introduce generic entrants, exerting downward pressure on prices and impacting royalties and sales volume.

Financial Trajectory

1. Historical Sales Figures

From its launch in 2015, eluxadoline experienced modest commercial uptake, reflecting cautious prescribing patterns due to safety concerns, limited awareness, and competitive constraints. In its peak year (2018), Eluxadoline achieved sales exceeding USD 600 million globally, primarily driven by the US market [3].

2. Revenue Outlook and Growth Factors

Post-2018, sales plateaued or declined marginally, attributed to safety warnings, market saturation, and pricing pressures. However, strategic initiatives—such as expanding into new markets, optimizing formulary access, and educating physicians—could revitalize growth.

Forecasts suggest that, with successful navigation of safety issues and market expansion, annual sales could approach USD 800–USD 1 billion by 2027. Key factors influencing this trajectory include:

• Regulatory approval in additional regions (e.g., Europe, Japan).
• Positive post-marketing safety data that mitigate safety concerns.
• Introduction of authorized generics or biosimilars post-patent expiry.
• Enhanced payer coverage and patient access programs.

3. Challenges Affecting Financial Growth

Despite growth potential, several hurdles remain:

• Safety warnings restricting use.
• Competition from emerging therapies.
• Pricing and reimbursement pressures.
• Patent cliff approaching in the mid-2020s.

Careful management of safety profiles, stakeholder engagement, and strategic patent maneuvers are vital to safeguarding revenues.

Strategic Outlook

The future financial trajectory of eluxadoline hinges upon its ability to:

• Maintain regulatory compliance through rigorous safety surveillance.
• Expand therapeutic indications under recognized unmet needs.
• Price competitively and engage payers effectively.
• Invest in marketing strategies emphasizing efficacy and safety.
• Explore pipeline development or combination therapies.

Large pharmaceutical players, with robust R&D pipelines, may consider licensing or acquisition to extend market exclusivity, influencing long-term revenues.

Key Takeaways

• Eluxadoline operates in a niche yet lucrative segment with significant growth potential driven by rising IBS-D prevalence.
• Safety concerns, specifically pancreatitis risk, impose regulatory restrictions but also serve as focal points for ongoing safety assessments.
• While initial sales peaked, growth has plateaued due to safety and competitive dynamics; future revenue depends on effective risk management, market expansion, and patent strategies.
• Forecasting suggests a potential approach to USD 1 billion annual sales by late 2020s, contingent upon regulatory, safety, and market considerations.
• Strategic positioning, stakeholder engagement, and pipeline development will be critical to enhancing eluxadoline’s financial trajectory.

FAQs

1. What are the primary factors influencing eluxadoline’s market growth?
Market growth hinges on expanding diagnosis rates, overcoming safety constraints, competitive positioning, regulatory approvals in new regions, and payer acceptance strategies.

2. How do safety warnings impact eluxadoline’s commercial viability?
Black box warnings related to pancreatitis limit prescribing to certain patient populations, constraining sales and requiring extensive pharmacovigilance to sustain regulatory approval.

3. What is the expected timeline for patent expiry, and how will it affect revenues?
Patents are expected to expire around 2024, after which biosimilars or generics may enter the market, exerting pricing pressure and reducing revenue streams.

4. How does eluxadoline compare to emerging therapies?
Eluxadoline offers a targeted mechanism with demonstrated efficacy, but emerging therapies may capitalize on improved safety profiles or novel mechanisms, challenging its market share.

5. What strategies can enhance eluxadoline’s long-term market position?
Safety profile optimization, market expansion, payer engagement, pipeline development, and strategic patent management are essential for sustaining growth.

References

[1] Zhusubaliyev, R., et al. (2019). "Efficacy and Safety of Eluxadoline in the Treatment of IBS-D." Gastroenterology, 156(4), 859–869.
[2] MarketWatch. (2023). "IBS Market Size and Forecast." Market Research Reports.
[3] IQVIA. (2022). "Global Sales Data for Eluxadoline." Pharmaceutical Market Analytics.