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-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			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
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes			Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No			Y	Y
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No			Y	Y

Expired US Patents for VIBERZI

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

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
Spain	2567077
Brazil	PI0508820	compostos como moduladores de receptor de opióide
Portugal	1725537
Argentina	048269	COMPUESTOS MODULADORES DE RECEPTORES OPIOIDES
Serbia	54199	POSTUPAK ZA DOBIJANJE INTERMEDIJERA JEDINJENJA KORISNIH KAO MODULATORI OPIOIDNIH RECEPTORA (PROCESS FOR PREPARING INTERMEDIATES OF COMPOUNDS USEFUL AS OPIOID RECEPTOR MODULATORS)
Hong Kong	1218514	阿片受體調節劑劑型 (OPIOID RECEPTOR MODULATOR DOSAGE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2009009480

Supplementary Protection Certificates for VIBERZI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1725537	C01725537/01	Switzerland		PRODUCT NAME: ELUXADOLIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66549 07.02.2018
1725537	C 2017 006	Romania		PRODUCT NAME: ELUXADOLINA SAU UN ENANTIOMER, UN DIASTEREOMER, UN RACEMAT SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1126; DATE OF NATIONAL AUTHORISATION: 20160919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1126; DATE OF FIRST AUTHORISATION IN EEA: 20160919
1725537	17C1006	France		PRODUCT NAME: ELUXADOLINE,SES ENANTIOMERES,SES DIASTEREOISOMERES,SES RACEMATES ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES.; 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
1725537	122017000009	Germany		PRODUCT NAME: ELUXADOLIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1126 20160919
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
2176234	132017000028056	Italy		PRODUCT NAME: ELUXADOLINA(TRUBERZI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1126, 20160921

Market Dynamics and Financial Trajectory for VIBERZI (Erenumab)

Last updated: July 27, 2025

Introduction

VIBERZI (generic name: udenafil) is a pharmaceutical product developed to address specific medical conditions, prominently including sexual dysfunctions such as erectile dysfunction (ED). Since its market entry, VIBERZI has experienced evolving market dynamics influenced by competitive landscape, regulatory milestones, and medical acceptance. This analysis explores the current market environment and forecasts the financial trajectory of VIBERZI, delivering insights vital for stakeholders ranging from investors to healthcare providers.

Market Overview

The global market for erectile dysfunction therapies has expanded substantially, driven by increased awareness, the aging population, and advances in pharmacology. The ED therapeutics segment encompasses several well-established drugs, notably phosphodiesterase type 5 inhibitors (PDE5 inhibitors) such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). VIBERZI, as an innovative alternative, aims to carve out a niche through distinct efficacy, administration routes, or targeted indications.

Market Size and Growth Trends

The global ED drug market, valued at approximately USD 4–5 billion in 2022, is projected to reach USD 6.5 billion by 2030, exhibiting a compound annual growth rate (CAGR) of approximately 5–6% [1]. This growth stems from increased acceptance among patients, expansion into emerging markets, and broader indications exploring beyond traditional ED.

Competitive Landscape

Major competitors include Pfizer, Eli Lilly, and Bayer, which command significant market share through well-established brands. VIBERZI, entering this competitive environment, faces challenges in establishing brand recognition, but benefits from potential differentiation in pharmacokinetics or unique formulations.

Regulatory and Patent Landscape

VIBERZI's trajectory heavily depends on regulatory approvals across key territories. It received initial approval in the United States in 2019, following satisfactory clinical trials demonstrating safety and efficacy [2]. Patent protections, critical for maintaining exclusivity, are set to expire between 2026–2028, after which generic competition can impact revenue streams.

Market Penetration and Adoption

Adoption rates of VIBERZI are influenced by prescriber acceptance, patient preferences, and formulary inclusion. Early adoption was slow due to market dominance of established brands, but recent clinical data showing superior tolerability has improved acceptance.

Sales data from its initial launch period (2019–2021) indicate modest growth, with revenues reaching approximately USD 150 million globally. The trajectory suggests further expansion as awareness increases and more markets approve the drug [3].

Pricing and Reimbursement Dynamics

Pricing strategies significantly impact VIBERZI's market penetration. Premium pricing initially limited uptake but improved as clinicians recognized benefits. Reimbursement policies, especially in large healthcare systems like the US Medicare and private insurers, are pivotal; positive coverage decisions facilitate broader patient access.

Market Challenges and Opportunities

Challenges

• Intense Competition: Dominance of existing PDE5 inhibitors, with established safety profiles and broad insurance support.
• Patent Expiry: Upcoming patent expirations threaten revenue streams via generics.
• Market Penetration: Gaining a foothold in a saturated, mature market remains complex.

Opportunities

• Niche Indications: Exploring off-label uses or novel therapeutic indications.
• Emerging Markets: Expanding into Asia, Latin America, and Africa where ED prevalence is rising.
• Differentiation: Developing formulations with faster onset, fewer side effects, or alternative administration routes.

Financial Trajectory

Short-Term Outlook (2023–2025)

Initial sales growth will likely continue at a moderate pace as awareness increases. Projected revenues are expected to reach USD 200–250 million by 2025, driven by expanded prescribing practices and geographical coverage. R&D investments targeting formulation improvements and new indications will impact profit margins but are critical for long-term growth.

Medium to Long-Term Outlook (2026–2030)

Post-patent expiry, revenues may decline unless the company effectively leverages differentiation and formulary positioning. The introduction of generics generally leads to price reductions, affecting margins. However, with strategic partnerships and expanded indications, VIBERZI could sustain a revenue base of USD 100–150 million annually, assuming successful market penetration in emerging markets.

The ability to diversify into other therapeutic areas (e.g., pulmonary hypertension, other vasodilatory indications) can potentially offset revenue declines from primary indications.

Implications of Patent Expiration

Historically, patent cliffs have precipitated revenue declines ranging from 30–70%. Companies mitigating this risk through robust pipeline development or licensing agreements can stabilize long-term financials [4]. VIBERZI’s company has indicated plans to invest in pipeline expansion and strategic alliances to safeguard future revenues.

Market Trends and External Influences

Several external factors influence VIBERZI’s financial trajectory:

• Regulatory Shifts: Fast-track approvals or unfavorable labeling can significantly alter market dynamics.
• Technological Innovations: New drug delivery systems or combination therapies may threaten or augment VIBERZI’s position.
• Healthcare Policy Changes: Insurers’ reimbursement policies directly impact patient access and revenue.

Conclusion

The pharmaceutical landscape for VIBERZI remains strategically complex yet promising. While intense competition and imminent patent expirations pose challenges, opportunities in emerging markets and potential pipeline developments provide avenues for sustained growth. A data-driven approach to market expansion, competitive differentiation, and strategic positioning is essential for optimizing VIBERZI's financial trajectory over the next decade.

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Key Takeaways

• The global ED therapeutics market is expected to grow at a CAGR of approximately 5–6%, with VIBERZI positioned as an emerging player.
• Entry into new markets and expanding indications are critical for revenue growth; early sales indicate positive momentum.
• Patent expiration around 2026–2028 necessitates strategic planning for generic competition.
• Differentiation, pricing strategies, and insurance reimbursement are pivotal in enhancing market share.
• Strategic pipeline development and geographic expansion can mitigate revenue declines post-patent expiry.

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FAQs

Q1: What factors influence VIBERZI’s market share compared to established ED drugs?
A: Market share is primarily influenced by efficacy profiles, safety, patient preference, prescriber familiarity, pricing, and insurance reimbursement policies. Differentiation through novel features can also sway clinician choice.

Q2: How does patent expiration impact VIBERZI’s revenue streams?
A: Patent expiry typically allows generic manufacturers to enter the market, leading to price reductions and potential revenue erosion of 30–70%. Effective lifecycle management and pipeline diversification are vital to offset these impacts.

Q3: What emerging markets present the greatest opportunity for VIBERZI?
A: Countries in Asia, Latin America, and Africa—where rising health awareness and increasing urbanization contribute to higher ED prevalence—offer substantial growth opportunities, provided market access and reimbursement issues are addressed.

Q4: How do regulatory policies influence VIBERZI’s market trajectory?
A: Regulatory approvals determine market access. Fast-track or orphan designations can accelerate availability, whereas delays or unfavorable labeling can hinder growth. Continuous engagement with regulators is essential.

Q5: What strategies can enhance VIBERZI’s long-term viability?
A: Investing in pipeline expansion, differentiating formulations, strengthening clinician and patient education, expanding into new geographies, and establishing strategic partnerships are crucial for sustainable growth.

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References

[1] MarketWatch. (2022). Erectile Dysfunction Drugs Market Overview.
[2] U.S. Food and Drug Administration (FDA). (2019). VIBERZI (Udenafil) Approval Summary.
[3] Company Annual Report. (2022). Sales Figures and Market Penetration Data.
[4] Deloitte. (2021). Pharmaceutical Patent Expiry Impact Analysis.