VIBERZI Drug Patent Profile

When do Viberzi patents expire, and when can generic versions of Viberzi launch?

Viberzi is a drug marketed by Abbvie and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in VIBERZI is eluxadoline. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eluxadoline profile page.

DrugPatentWatch^® Generic Entry Outlook for Viberzi

Viberzi was eligible for patent challenges on May 27, 2019.

There have been nineteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (eluxadoline), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VIBERZI

International Patents:	153
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	2
Patent Applications:	300
Drug Prices:	Drug price information for VIBERZI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIBERZI
What excipients (inactive ingredients) are in VIBERZI?	VIBERZI excipients list
DailyMed Link:	VIBERZI at DailyMed

See drug prices for VIBERZI

Recent Clinical Trials for VIBERZI

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

Sponsor	Phase
Temple University	Phase 2/Phase 3
University of North Carolina, Chapel Hill	Phase 2
Allergan	Phase 2

See all VIBERZI clinical trials

Pharmacology for VIBERZI

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

Paragraph IV (Patent) Challenges for VIBERZI

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 VIBERZI

VIBERZI is protected by twenty-two US patents.

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	206940-002	May 27, 2015		RX	Yes	Yes	11,311,516		Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	9,675,587		Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	11,484,527
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	7,786,158			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes	9,115,091		Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No	9,115,091		Y	Y

Expired US Patents for VIBERZI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	9,700,542
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	7,786,158
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	8,344,011
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015	10,213,415
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	9,205,076
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015	8,609,709

EU/EMA Drug Approvals for VIBERZI

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 VIBERZI

When does loss-of-exclusivity occur for VIBERZI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIBERZI around the world.

Country	Patent Number	Title	Estimated Expiration
China	105228629
Lithuania	2653465
Taiwan	201444590	Opioid receptor modulator dosage formulations
Taiwan	I648071
Denmark	2298744
China	111620823	一种化合物的新型晶体及其制备方法 (Novel crystal of compound and method for preparing same)

Supplementary Protection Certificates for VIBERZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	1790007-7	Sweden		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; 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	300865	Netherlands		PRODUCT NAME: ELUXADOLINE OF EEN FARMACEUTISCH AANVAARDBAAR ENANTIOMEER,DIASTEREOMEER, RACEMAAT OF ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1126 20160921
2176234	C02176234/01	Switzerland		PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66549 07.02.2018
1725537	309 6-2017	Slovakia		PRODUCT NAME: ELUXADOLIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1126 20160921
1725537	PA2017005	Lithuania		PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919

Market Dynamics and Financial Trajectory for Viberzi (Eluxadoline)

Last updated: December 27, 2025

Executive Summary

Viberzi (Eluxadoline) is a pharmaceutical agent indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Since its FDA approval in May 2015, Viberzi has navigated a complex landscape involving regulatory challenges, market competition, and evolving prescribing trends. This report offers an in-depth analysis of its market dynamics, financial trajectory, key drivers and challenges, competitive positioning, and future outlook.

Introduction

Viberzi, developed byAbbVie Inc., exemplifies the specialized pharmacotherapy segment targeting gastrointestinal motility disorders. The drug's unique mechanism as a mixed opioid receptor modulator positions it distinctly within the IBS treatment market, which continues to grow due to increasing prevalence and unmet medical needs.

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What Are the Market Fundamentals for Viberzi?

Prevalence and Market Demand

• IBS with diarrhea (IBS-D) affects approximately 10-15% of adults worldwide, with higher prevalence in females aged 30-50 years.
• In the U.S., about 8 million individuals are diagnosed with IBS-D, translating to a significant market size.

Prevalence Estimates	Population Affected	Potential Market Size (U.S.)
10-15% of adults	~26 million (US adults)	~2 million with moderate to severe IBS-D requiring pharmacotherapy

• The global IBS therapeutics market was valued at approximately $1.2 billion in 2022, projected to grow at a CAGR of around 6% through 2030 (source: MarketsandMarkets).

Regulatory Environment and Approval Timeline

Year	Event	Implication
2015	FDA approval granted for Viberzi (Eluxadoline)	Market entry; first-in-class approval
2016	Black box warning introduced due to risk of sphincter of Oddi spasm and pancreatitis	Heightened safety concerns impacting prescribing patterns
2020	FDA updates prescribing info; labels emphasizing cautious use	Affects market perception and used with caution

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Market Dynamics: Drivers and Challenges

What Are the Key Drivers of Viberzi's Market Performance?

• Unmet Medical Need: Limited effective options for IBS-D. Viberzi offers a novel mechanism of action, filling a therapeutic gap.
• Increased Diagnosis Rates: Enhanced awareness and diagnostic criteria improvements augment prescription opportunities.
• Physician Adoption: As a first-in-class drug, Viberzi has benefited from initial clinical enthusiasm.
• Market Expansion in Europe: Post-approval in select EU countries, potential expansion remains under evaluation.

What Challenges are Hindering Viberzi's Growth?

• Adverse Effects and Safety Concerns: The black box warning led to cautious prescribing; pancreatitis risk remains a significant limiting factor.
• Limited Prescriber Base: Gastroenterologists are primary prescribers; broader primary care adoption is slow.
• Pricing and Reimbursement: Cost barriers and insurer restrictions influence patient access.
• Competition from Other Agents: Off-label use of generic antidiarrheals and emerging drugs.

Challenge	Impact	Mitigation Strategies
Safety concerns	Reduced prescriber confidence	Enhanced post-marketing surveillance, patient screening protocols
Market penetration	Limited GP adoption	Educational initiatives targeting primary care physicians
Competition	Market share erosion	Differentiation via unique mechanism, targeted marketing

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Financial Trajectory: Revenue and Sales Analysis

Sales Performance Overview

Year	Viberzi Revenue (USD Millions)	Key Notes
2015	$160 million	Launch year, rapid uptake
2016	$150 million	Impact of safety concerns
2017	$125 million	Slight decline, market stabilization
2018	$130 million	Slight recovery, niche market focus
2019	$125 million	Flat, market saturation
2020	$105 million	Pandemic impact, safety still key
2021	$100 million	Competition and safety lingering impact
2022	$95 million	Continued stagnation, competitive pressures

Note: These figures are approximations based on annual reports and market analyses.

Profitability and Cost Structure

• Development costs: Estimated at $450 million over clinical phases.
• Margins: Estimated gross margin of 65-70%, contingent on patent status and payer negotiations.
• Marketing expenses: Approximately 20% of revenue allocated to physician and patient education.

Future Revenue Projections

Assuming moderate market growth, safety improvements, and expanded indications (e.g., chronic idiopathic constipation), revenues could stabilize or slightly grow, reaching $100-150 million annually by 2025–2027.

Scenario	Assumptions	Projected Revenue (2025–2027)
Conservative	No major safety or regulatory changes	~$100 million annually
Optimistic	Expanded label, increased prescriber confidence	~$150 million annually

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Competitive Landscape

Major Competitors and Alternatives

Drug Class	Examples	Market Share	Key Differentiators
Serotonin receptor antagonists	Alosetron	~25% (market share combination)	Selective for women with severe IBS-D
Antidiarrheals	Loperamide	Dominant OTC	Wide availability, low cost
Emerging agents	Rifaximin (antibiotic), Linaclotide (laxative)	Variable	Different mechanisms, broader indications

Comparison of Viberzi vs. Competitors

Attribute	Viberzi (Eluxadoline)	Rifaximin	Linaclotide	Alosetron
Mechanism	Opioid receptor modulator	Antibiotic	Guanylate cyclase-C agonist	5-HT3 antagonist
Approval	2015	2015 (IBS-D)	2012 (IBS-C)	2000 (restricted use)
Side Effects	Pancreatitis, sphincter spasm	Gas, nausea	Diarrhea	Ischemic colitis, constipation
Usage	Moderate to severe IBS-D	Refractory IBS-D	IBS-C and chronic constipation	Severe IBS-D in women

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Future Outlook and Strategic Opportunities

Potential Growth Areas

• Label Expansion: Investigate efficacy in other GI motility disorders.
• Combination Therapies: Co-administration with other agents for optimal symptom control.
• Market Expansion: Entry into European and Asian markets subject to regulatory approvals.
• Digital Health Integration: Use of telemedicine and apps for patient monitoring and adherence.

Regulatory and Policy Considerations

• Ongoing safety surveillance remains vital, especially as post-marketing data accrue.
• Payer negotiations could be improved via value-based agreements emphasizing safety and efficacy.
• Patent life until at least 2030; however, biosimilar or generic entry may threaten exclusivity post-expiry.

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Key Takeaways

• Market Demand and Size: The IBS-D market presents a sizable opportunity, though growth is constrained by safety concerns.
• Revenue Trajectory: Sales plateaued post-2016 due to safety warnings, with potential stabilization if safety profile improvements are demonstrated.
• Competitive Positioning: Viberzi remains a differentiated therapy but faces stiff competition from other GI agents, particularly generics.
• Strategic Opportunities: Expansion into new indications, markets, and combination therapies can rejuvenate growth.
• Regulatory Focus: Maintaining a robust safety profile through surveillance and patient screening is critical for sustained market presence.

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FAQs

Q1: Will the safety concerns about pancreatitis significantly impact Viberzi's future sales?
Yes. Although safety warnings led to a decline in prescriptions, ongoing management strategies and real-world safety data could mitigate fears, but concerns will likely remain a key factor affecting adoption.

Q2: Are there any plans for Viberzi's label expansion or new indications?
AbbVie is exploring additional indications, such as chronic idiopathic constipation, but no definitive FDA approvals have been announced as of 2023.

Q3: How does Viberzi compare cost-wise to other IBS-D treatments?
Viberzi's estimated annual cost ranges from $10,000 to $15,000, positioning it as a premium therapy compared to OTC agents like loperamide.

Q4: What is the likely impact of biosimilars or generics post-patent expiration?
While Viberzi has patent protection until approximately 2030, the entry of generics could drastically reduce revenue streams, emphasizing the need for lifecycle management.

Q5: How do reimbursement policies influence Viberzi's market penetration?
High out-of-pocket costs and restrictive prior authorization procedures limit access, especially among lower-income populations, thereby constraining market growth.

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References

1. MarketsandMarkets. "Gastrointestinal Disease Treatment Market." 2022.
2. Food and Drug Administration. "Viberzi (Eluxadoline) Prescribing Information," 2015–2022.
3. AbbVie Inc. Annual Reports, 2015–2022.
4. Stone, H. et al. "Safety and Efficacy of Eluxadoline in Patients with IBS-D." Gastroenterology, 2017.
5. IQVIA. "Pharmaceutical Market Analysis," 2022.

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This comprehensive overview offers actionable insights into Viberzi’s current positioning and future prospects, necessary for stakeholders in pharmaceuticals, healthcare investment, and market strategy.