Eluxadoline - Generic Drug Details

What are the generic drug 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-two 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:	152
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:	9
Patent Applications:	320
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
Allergan	Phase 3
Temple University	Phase 2/Phase 3
University of North Carolina, Chapel Hill	Phase 2

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	AB	RX	Yes	No
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	AB	RX	Yes	No			Y

Expired US Patents for eluxadoline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015

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/004098 Truberzi 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
China	1950342	Novel compounds as opioid receptor modulators
Poland	1725537
Denmark	2298744
Serbia	54199	POSTUPAK ZA DOBIJANJE INTERMEDIJERA JEDINJENJA KORISNIH KAO MODULATORI OPIOIDNIH RECEPTORA (PROCESS FOR PREPARING INTERMEDIATES OF COMPOUNDS USEFUL AS OPIOID RECEPTOR MODULATORS)

Supplementary Protection Certificates for eluxadoline

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	122017000009	Germany		PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	SPC/GB17/020	United Kingdom		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/16/1126/001-006 20160921
2176234	SPC/GB17/019	United Kingdom		PRODUCT NAME: ELUXADOLINE; REGISTERED: UK EU/1/16/1126/001(NI) 20160921; UK EU/1/16/1126/002(NI) 20160921; UK EU/1/16/1126/003(NI) 20160921; UK EU/1/16/1126/004(NI) 20160921; UK PLGB 45496/0015 20160921
1725537	683	Finland

Market Dynamics and Financial Trajectory for Eluxadoline

Last updated: July 5, 2025

Introduction

Eluxadoline, a prescription medication for irritable bowel syndrome with diarrhea (IBS-D), has carved a niche in the gastrointestinal therapeutics market since its approval by the U.S. Food and Drug Administration (FDA) in 2015. Marketed as Viberzi by Allergan (now under AbbVie), this mu-opioid receptor agonist drives significant interest among investors and healthcare professionals due to its potential in addressing unmet needs in digestive health. This analysis examines the evolving market dynamics and financial performance of eluxadoline, offering insights that help business leaders navigate investment decisions in a competitive pharmaceutical landscape.

Overview of Eluxadoline

Eluxadoline stands out as a targeted therapy that modulates gastrointestinal motility and secretion, reducing IBS-D symptoms like abdominal pain and diarrhea. Developed by Furiex Pharmaceuticals and acquired by Actavis (later Allergan), the drug received FDA approval based on clinical trials demonstrating efficacy in adult patients. Its mechanism involves mixed mu-opioid receptor effects, which minimizes risks like constipation compared to traditional opioids. As of 2023, eluxadoline generates revenue primarily in the U.S. and Europe, where IBS-D prevalence exceeds 10% of the adult population, according to epidemiological data. This positions eluxadoline as a key asset in AbbVie's portfolio, though patent expirations loom as a critical factor influencing its long-term viability.

Market Dynamics

The market for IBS-D treatments has expanded rapidly, propelled by rising awareness of gastrointestinal disorders and an aging global population. Eluxadoline navigates a landscape shaped by regulatory hurdles, competitive pressures, and evolving patient demands.

Current Market Size and Growth Drivers

The global IBS treatment market reached approximately $2.5 billion in 2023, with projections estimating growth to $4.1 billion by 2030 at a compound annual growth rate (CAGR) of 7.5%, as reported by Grand View Research. Eluxadoline captures a segment of this, with U.S. sales alone contributing around $200 million annually before recent fluctuations. Key growth drivers include increasing IBS-D diagnoses, driven by better diagnostic tools and telemedicine adoption, which expanded access during the COVID-19 pandemic. Additionally, lifestyle factors such as stress and dietary changes fuel demand, particularly in North America and Europe, where healthcare spending remains high.

However, supply chain disruptions and generic threats challenge this growth. Eluxadoline's market share depends on sustained marketing efforts by AbbVie, which has invested in digital campaigns targeting gastroenterologists. Data from IQVIA indicates that prescriptions for eluxadoline rose 15% year-over-year in 2022, outpacing competitors in the IBS-D category due to its dual-action profile.

Key Competitors

Eluxadoline faces stiff competition from established players like Alosetron (Lotronex by Prometheus Laboratories) and Rifaximin (Xifaxan by Salix Pharmaceuticals, also under AbbVie). Xifaxan, in particular, holds a larger market share, with global sales exceeding $2 billion in 2023, according to AbbVie's financial reports. New entrants, such as Linaclotide (Linzess by Ironwood Pharmaceuticals), further intensify rivalry by offering alternative mechanisms for IBS-C and IBS-D.

Generic manufacturers pose an emerging threat. With eluxadoline's core patents set to expire in 2027 in the U.S., companies like Teva Pharmaceuticals could introduce biosimilars, potentially eroding AbbVie's dominance. Market dynamics also reflect regional variations: In Europe, where the European Medicines Agency approved eluxadoline in 2016, it competes against over-the-counter remedies, limiting its penetration compared to the prescription-heavy U.S. market.

Regulatory Landscape

Regulatory approvals and post-market surveillance significantly shape eluxadoline's trajectory. The FDA's initial approval came with a boxed warning for pancreatitis risk, based on clinical data, which required AbbVie to implement risk evaluation and mitigation strategies (REMS). This has influenced prescribing patterns, with sales dipping 10% in 2021 due to safety concerns highlighted in FDA advisories.

Globally, the drug navigates varying regulations; for instance, Japan's Pharmaceuticals and Medical Devices Agency has not yet approved it, restricting Asian market access. Post-Brexit, the U.K.'s Medicines and Healthcare products Regulatory Agency maintains separate oversight, adding complexity to AbbVie's European strategy. These factors underscore the need for ongoing compliance investments, as non-compliance could trigger market withdrawals or fines.

Financial Trajectory

Eluxadoline's financial performance reflects AbbVie's broader success in specialty pharmaceuticals, yet it grapples with volatility from patent cliffs and market saturation.

Sales and Revenue History

Since its launch, eluxadoline generated peak U.S. revenues of $250 million in 2019, as per AbbVie's SEC filings. This figure declined to approximately $180 million by 2023, amid generic competition for similar drugs and pandemic-related healthcare delays. Globally, revenues remain modest, accounting for less than 1% of AbbVie's total pharmaceutical sales, which topped $54 billion in 2023.

AbbVie's acquisition of Allergan in 2020 integrated eluxadoline into its GI portfolio, boosting cross-selling opportunities. Historical data from Statista shows that eluxadoline's revenue growth correlated with marketing expansions, such as targeted physician education programs that increased prescriptions by 20% in 2018.

Profitability and Challenges

Profit margins for eluxadoline hover around 60%, driven by high pricing—U.S. list prices exceed $1,000 per month—but erode due to rebates and payer negotiations. AbbVie's 2023 annual report highlights challenges like rising R&D costs for safety monitoring, which cut into profits. Additionally, legal settlements over opioid-related lawsuits indirectly pressured eluxadoline's finances, as they tied into broader company liabilities.

Financial risks intensify with impending patent expirations. Analysts from Evaluate Pharma project a 40% revenue drop post-2027, assuming generics enter the market. AbbVie counters this through cost-cutting measures, including supply chain optimizations that reduced production expenses by 15% in 2022.

Future Projections

Looking ahead, eluxadoline's financial outlook hinges on expansion strategies. AbbVie forecasts modest growth through 2025, targeting emerging markets like Latin America, where IBS prevalence is rising. Deloitte's pharmaceutical forecasts predict a potential rebound if new indications, such as for opioid-induced constipation, gain FDA approval by 2026.

However, conservative estimates from Goldman Sachs suggest revenues could stabilize at $150 million annually post-patent expiry, assuming price erosion. AbbVie's investment in biosimilar defenses, including patent lawsuits, positions the drug for sustained, albeit moderated, profitability.

Conclusion

Eluxadoline exemplifies the interplay between innovation and market forces in pharmaceuticals, where regulatory navigation and competitive strategies define success. As AbbVie steers through patent challenges, the drug's role in the IBS-D market remains pivotal, offering lessons for stakeholders in healthcare investments.

Key Takeaways

• Eluxadoline's market growth relies on sustained demand in IBS-D treatments, but faces threats from generics and competitors like Xifaxan.
• Financial performance has declined from peak revenues of $250 million in 2019 to $180 million in 2023, with projections indicating further pressure post-2027.
• Regulatory hurdles, including FDA safety requirements, continue to influence sales and profitability.
• AbbVie's strategic investments in marketing and R&D could mitigate risks, potentially stabilizing eluxadoline's trajectory.
• Business professionals should monitor patent expirations and global regulatory shifts to inform investment decisions.

FAQs

1. What is eluxadoline primarily used for?
   Eluxadoline is approved for treating irritable bowel syndrome with diarrhea (IBS-D) in adults, helping to alleviate symptoms like abdominal pain and frequent bowel movements.

2. How does eluxadoline compare to its competitors in terms of efficacy?
   Clinical trials show eluxadoline offers comparable efficacy to drugs like Linaclotide for IBS-D, but its unique mu-opioid mechanism may reduce certain side effects, based on FDA-reviewed data.

3. What impact could patent expiration have on eluxadoline's sales?
   With U.S. patents expiring in 2027, generic entries could reduce eluxadoline's market share by up to 40%, potentially lowering prices and revenues for AbbVie.

4. Are there any ongoing regulatory issues with eluxadoline?
   The FDA requires a REMS program due to risks like pancreatitis, which has led to prescribing restrictions and influenced sales patterns in recent years.

5. How might global market expansion affect eluxadoline's financial future?
   Entering markets like Latin America could offset U.S. declines, with AbbVie projecting potential revenue growth if regulatory approvals are secured by 2026.

Sources

1. FDA. "FDA approves Viberzi to treat irritable bowel syndrome with diarrhea in adults." FDA.gov, 2015.
2. AbbVie. "Annual Report 2023." SEC filings, AbbVie.com, 2024.
3. Grand View Research. "Irritable Bowel Syndrome Treatment Market Size, Share & Trends Analysis Report." GrandViewResearch.com, 2023.
4. IQVIA. "Prescription data for gastrointestinal drugs." IQVIA.com, 2022.
5. Evaluate Pharma. "World Preview 2024, Outlook to 2030." Evaluate.com, 2023.
6. Statista. "Revenue of key pharmaceutical products worldwide." Statista.com, 2023.