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VIBERZI Drug Patent Profile

When do Viberzi patents expire, and what generic alternatives are available?

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-two 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2033. This may change due to patent challenges or generic licensing.

There have been seven 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:	152
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	2
Patent Applications:	100
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIBERZI

NDA:

206940

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VIBERZI

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

Sponsor	Phase
Temple University	Phase 2/Phase 3
Allergan	Phase 2
University of North Carolina, Chapel Hill	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-one US patents.

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

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			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes				Y

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/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 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
Japan	2019014744	オピオイド受容体モジュレーターの投与製剤 (DOSAGE FORMULATIONS OF OPIOID RECEPTOR MODULATOR)
Hungary	S1700011
Japan	2016128433	５−（｛［２−アミノ−３−（４−カルバモイル−２，６−ジメチル−フェニル）−プロピオニル］−［１−（４−フェニル−１Ｈ−イミダゾール−２−イル）−エチル］−アミノ｝−メチル）−２−メトキシ−安息香酸の新規な結晶及び製造方法 (NEW CRYSTALS AND METHODS OF MAKING 5-({[2-AMINO-3-(4-CARBAMOYL-2,6-DIMETHYL-PHENYL)-PROPIONYL]-[1-(4-PHENYL-1H-IMIDAZOL-2-YL)-ETHYL]-AMINO}-METHYL)-2-METHOXY-BENZOIC ACID)
Canada	2560047	NOUVEAUX COMPOSES EN TANT QUE MODULATEURS DE RECEPTEURS D'OPIOIDES (NOVEL COMPOUNDS AS OPIOID RECEPTOR MODULATORS)

Supplementary Protection Certificates for VIBERZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2017005	Lithuania		PRODUCT NAME: ELUKSADOLINAS ARBA JO FARMACINIU POZIURIU PRIIMTINAS ENANTIOMERAS, DIASTEREOMERAS, RACEMATAS ARBA DRUSKA; REGISTRATION NO/DATE: EU/1/16/1126 20160919
1725537	C20170005 00225	Estonia		PRODUCT NAME: ELUKSADOLIIN;REG NO/DATE: EU/1/16/1126 21.09.2016
1725537	2017/007	Ireland		PRODUCT NAME: ELUXADOLINE OR A PHARMACEUTICALLY ACCEPTABLE ENANTIOMER, DIASTEREOMER, RACEMATE OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1126 20160919

VIBERZI Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Viberzi

Introduction to Viberzi

Viberzi, known by its generic name eluxadoline, is a medication approved by the FDA in 2015 for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D). It has been a significant player in the IBS treatment market, particularly for patients suffering from IBS-D.

Market Position and Revenue

Dominance in IBS-D Segment

Viberzi dominates the IBS-D segment, which held the largest revenue share of 49.8% in the global IBS treatment market in 2024. This dominance is attributed to the rise in diagnosed cases of IBS-D and an increasing understanding of the condition's impact on quality of life[1][4].

Revenue Growth

The drug is expected to grow at a CAGR of 7.5% over the forecast period from 2025 to 2030. This growth is driven by its unique mechanism of action, which helps regulate bowel function and reduce abdominal discomfort, making it a preferred choice for many patients[1][4].

Clinical Efficacy and Patient Preference

Mechanism of Action

Viberzi's effectiveness stems from its ability to target the mu-opioid receptors in the gut, which helps in reducing the frequency of bowel movements and alleviating abdominal pain. This mechanism makes it particularly effective for patients with IBS-D[1][3].

Patient Outcomes

Clinical trials have shown positive results for Viberzi, with patients experiencing significant improvements in their symptoms over several months or a year. Common side effects, although generally mild, include constipation, nausea, and abdominal pain[3].

Safety Concerns and Regulatory Updates

FDA Approval and Safety Announcements

While Viberzi was approved by the FDA in 2015 based on its safety and effectiveness in clinical trials, subsequent reports highlighted a risk of pancreatitis, particularly in patients without gallbladders. By March 2017, the FDA had issued a safety announcement warning about this risk, following 120 reports of pancreatitis, including two fatalities[3].

Market Drivers

Increasing Prevalence of IBS-D

The growing prevalence of IBS-D, influenced by factors such as stress and unhealthy diets, is a key driver for the demand of Viberzi. As more cases are diagnosed, the need for effective treatments increases, contributing to the market growth[1].

Advancements in Drug Development

Ongoing clinical trials and research into innovative therapies for IBS-D are expected to enhance treatment options and solidify Viberzi's position in the market. These advancements address unmet needs and improve patient outcomes, further driving market growth[1].

Patient Education and Awareness

Growing emphasis on patient education and awareness campaigns encourages individuals to seek appropriate care, thereby expanding the market for IBS-D treatments like Viberzi[1].

Regional Market Performance

Global Market

The global IBS treatment market, including Viberzi, is anticipated to grow at a CAGR of 8.8% from 2025 to 2030. This growth is driven by increasing awareness about IBS and its treatment options, as well as advancements in drug development[1].

Asia Pacific Region

The Asia Pacific region is expected to grow at a CAGR of 9.8% over the forecast period, driven by increasing awareness about gastrointestinal disorders, rising prevalence of IBS, and improved healthcare access and infrastructure. This region presents a significant opportunity for Viberzi and other IBS treatments[1].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies have led the market in terms of revenue share, attributed to their comprehensive infrastructure and integrated patient care systems. Viberzi, being a prescription medication, benefits from the strong presence of hospital pharmacies[1][4].

Financial Performance of Manufacturers

Allergan's Financials

Allergan, the original manufacturer of Viberzi before its acquisition by AbbVie, reported significant financial metrics. Although the company faced operational losses in certain quarters, the non-GAAP operating income remained substantial. The financial performance of Allergan, and now AbbVie, reflects the overall market dynamics and the revenue generated by drugs like Viberzi[2][5].

Challenges and Future Outlook

Side Effects and Safety Concerns

Despite its efficacy, Viberzi faces challenges related to its side effects, particularly the risk of pancreatitis. Ongoing monitoring and safety updates by regulatory bodies are crucial for maintaining patient trust and ensuring the drug's continued market presence[3].

Competitive Landscape

The IBS treatment market is competitive, with other drugs like Linzess (linaclotide) and Amitiza (lubiprostone) also gaining significant market share. Viberzi must continue to demonstrate its unique benefits and safety profile to maintain its market position[1][4].

Key Takeaways

• Market Dominance: Viberzi dominates the IBS-D segment with a significant revenue share.
• Growth Prospects: Expected to grow at a CAGR of 7.5% from 2025 to 2030.
• Clinical Efficacy: Effective in regulating bowel function and reducing abdominal discomfort.
• Safety Concerns: Associated with a risk of pancreatitis, particularly in patients without gallbladders.
• Market Drivers: Increasing prevalence of IBS-D, advancements in drug development, and patient education.
• Regional Performance: Strong growth anticipated in the Asia Pacific region.

FAQs

What is Viberzi used for?

Viberzi is used for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D).

What are the common side effects of Viberzi?

Common side effects include constipation, nausea, and abdominal pain. However, it also carries a risk of pancreatitis, especially in patients without gallbladders.

How does Viberzi work?

Viberzi targets the mu-opioid receptors in the gut to reduce the frequency of bowel movements and alleviate abdominal pain.

What is the market growth outlook for Viberzi?

Viberzi is expected to grow at a CAGR of 7.5% from 2025 to 2030.

Which region is expected to see significant growth for Viberzi?

The Asia Pacific region is expected to grow at a CAGR of 9.8% over the forecast period, driven by increasing awareness and improved healthcare access.

Sources

1. Grand View Research: Irritable Bowel Syndrome Treatment Market Size Report 2030.
2. PR Newswire: Allergan Reports Third Quarter 2019 Financial Results.
3. Miller & Zois: Viberzi and Pancreatitis.
4. Research and Markets: Irritable Bowel Syndrome Treatment Market Size & Competitors.
5. AbbVie: Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results.