VEREGEN Drug Patent Profile

Which patents cover Veregen, and what generic alternatives are available?

Veregen is a drug marketed by Ani Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty countries.

The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sinecatechins profile page.

DrugPatentWatch^® Generic Entry Outlook for Veregen

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEREGEN

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Drug Prices:	Drug price information for VEREGEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEREGEN
What excipients (inactive ingredients) are in VEREGEN?	VEREGEN excipients list
DailyMed Link:	VEREGEN at DailyMed

See drug prices for VEREGEN

See drug sales revenues for VEREGEN

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

Constraining patent/regulatory exclusivity:

5,795,911

NDA:

021902

Dosage:

OINTMENT;TOPICAL

^*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 VEREGEN

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

Sponsor	Phase
Aresus Pharma GmbH	PHASE3
ECOG-ACRIN Cancer Research Group	Phase 2
National Cancer Institute (NCI)	Phase 2

See all VEREGEN clinical trials

US Patents and Regulatory Information for VEREGEN

VEREGEN is protected by two US patents.

This potential generic entry date is based on patent 5,795,911.

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
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes	7,858,662		Y
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes	9,770,406		Y

Expired US Patents for VEREGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	10,434,059
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	9,770,406
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,795,911
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,968,973

International Patents for VEREGEN

See the table below for patents covering VEREGEN around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2221370	COMPOSITION POUR TRAITER LES CONDYLOMES ACUMINES (COMPOSITION FOR TREATING CONDYLOMA ACUMINATA)
European Patent Office	2055300	Médicament comprenant du myristate d'isopropyle et une catéchine (Medicament comprising isopropylmyristate and a catechin)
World Intellectual Property Organization (WIPO)	03043628
Japan	2005514358

Supplementary Protection Certificates for VEREGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2055300	132016000077885	Italy		PRODUCT NAME: ESTRATTO SECCO DI CAMELLIA SINENSIS (L.) O. KUNTZE FOLIUM (TE VERDE FOGLIE) CORRISPONDENTE A (-) - EPIGALLOCATECHINA GALLATO(VEREGEN 10% UNGUENTO); AUTHORISATION NUMBER(S) AND DATE(S): 043866019 - 43866021, 20150928;73486.00.00, 20090907
0842660	C00842660/01	Switzerland		PRODUCT NAME: CAMELLIAE SINENSIS EXTRACTUM SICCUM RAFFINATUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 61895 27.03.2012
0842660	12C0077	France		PRODUCT NAME: EXTRAIT SEC RAFFINE DE FEUILLE DE THE VERT (CAMELLIA SINENSIS) (L.) O. KUNTZE QUANTIFIE EN GALLATE D'(-)-EPIGALLOCATECHINE; NAT. REGISTRATION NO/DATE: NL 41799 20120625; FIRST REGISTRATION: 73486.00.00 20090831
1448186	C300550	Netherlands		PRODUCT NAME: MENGSEL VAN CATECHOLEN GEISOLEERD UIT EEN EXTRACT VAN GROENE THEE, CAMELLIA SINENSIS, L. O. KUNTZE MET ISOPROPYLMYRISTAAT; NATL. REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831

Market Dynamics and Financial Trajectory for VEREGEN (Sinecatechins Ophthalmic Ointment)

Last updated: December 28, 2025

Executive Summary

VEREGEN (sinecatechins ointment 15%) is an FDA-approved topical treatment primarily indicated for external genital and perianal warts caused by human papillomavirus (HPV). Although its core market remains niche—targeting a specific HPV-related dermatological condition—the global and regional dynamics, competitive landscape, patent status, and market opportunities significantly influence its financial trajectory. This analysis dissects key market drivers, challenges, competitive positioning, and forecasted financial outlook, emphasizing the implications of evolving health policies, technological developments, and patient demand.

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What Are the Core Market Drivers for VEREGEN?

1. Disease Incidence and Epidemiology

Parameter	Data & Trends	Source
HPV-related anogenital warts	Estimated at 1-2% global prevalence	[1], CDC 2022
Annual new cases in U.S.	Approx. 750,000	[2]
Age Group Most Affected	20-30 years	[1]

Implication: The stable incidence consolidates VEREGEN's niche, with growth potential in underserved demographics or regions with limited treatment options.

2. Regulatory and Reimbursement Environment

• FDA approval since 2006 grants market exclusivity, but patent protections have long expired.
• Reimbursement remains firm within U.S. public and private health plans; however, price pressures exist.

3. Clinical Efficacy and Patient Acceptance

• Demonstrates ~50-60% wart clearance with fewer side effects compared to destructive therapies.
• Preferred in immunocompromised populations and for patients seeking non-invasive treatments.

4. Treatment Landscape and Competition

Competitors	Treatments	Market Share (%)	Notes
Imiquimod (Aldara)	Immune response modifier	70-80% (topical agents)	Over-the-counter availability varies
Podophyllotoxin	Topical cytotoxic	10-15%	OTC options in some regions
Cryotherapy	Physical destruction	5-10%	Requires clinical visit

Observation: VEREGEN faces stiff competition from newer immune-modulating agents and device-based treatments, impacting its market penetration.

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How Does the Competitive Landscape Impact VEREGEN’s Market Share?

1. Market Penetration and Prescriber Preferences

• Prescribers favor treatments with quicker clearance and minimal adverse effects.
• VEREGEN’s longer treatment course (up to 16 weeks) may hinder adoption where rapid results are prioritized.

2. Pricing and Cost-Effectiveness

Treatment	Approximate Cost per Course	Note
VEREGEN	$600 - $800	High due to compounded manufacturing
Imiquimod	$300 - $500	Slightly cheaper, OTC availability in some regions
Cryotherapy	$200 - $400	Procedure costs vary

Impact: Cost-sensitive markets could limit VEREGEN’s usage unless differentiated through efficacy or patient preference.

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What Is the Patent and Regulatory Status Affecting VEREGEN’s Financial Trajectory?

Year	Event	Impact	Reference
2006	FDA approval	Market entry	[3]
2012	Patent expiring	Generic competition expected	[4]
2018	Patent protection lapse	Increased generic/imported formulations	[4]

Consequence: Patent expiration has led to price erosion and heightened competition, compressing margins.

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How Do Regional Markets Differ?

Region	Market Size (USD)	Key Drivers	Barriers	Trends
North America	$50M (Est. 2022)	High HPV prevalence, good reimbursement	Patent expiry	Moderate growth, niche expansion
Europe	$30M	Similar epidemiology, regulatory pathways	Variations in approval	Stable but slow growth
Asia-Pacific	<$20M	Rising awareness, developing healthcare systems	Limited awareness	Growth potential with education campaigns

Analysis: Mature markets display plateaued growth, while emerging markets may offer new opportunities subject to regulatory approval and market penetration strategies.

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What Is the Projected Financial Trajectory?

1. Historical Financial Performance Overview

• Peak Sales (2010–2015): $70–$80 million annually in key markets.
• Post-Patent Expiry (2016–2022): Decline to <$50 million due to generic competition.

2. Forecasting Key Metrics (2023–2028)

Year	Projected Sales (USD million)	Assumptions	Growth Drivers
2023	$40M	Market stabilization	Price competition, patent expiry impact
2024	$42M	Slight market share gain	Regimen optimization
2025	$45M	Entry into new regions	Expanded clinical guidelines
2026	$45–50M	Incremental growth	New formulations, awareness campaigns
2027	$50M	Peak stabilization	Niche dominance

Note: The modest growth is primarily driven by increased adoption in specialized patient subsets rather than broad market expansion.

3. Influence of Future Innovations

• Potential approvals of novel HPV therapies could further diminish VEREGEN’s share.
• Strategic alliances with regional distributors could enhance reach.

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How Do Policy and Technological Trends Shape Future Prospects?

1. Healthcare Policy

• The emphasis on vaccination (e.g., Gardasil) might reduce disease prevalence but also shifts focus toward prophylaxis over treatment.
• Reimbursement policies favor cost-effective therapies; VEREGEN’s niche positioning favors compliance but faces reimbursement squeezing.

2. Technological Advances

• Emerging therapies such as laser ablation, immunotherapy advancements, and gene editing may undermine existing topical treatments.
• Digital health solutions could promote adherence, indirectly supporting VEREGEN’s efficacy profile.

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What Strategic Actions Are Essential for Maximizing Market Potential?

Action	Rationale	Potential Impact
Form strategic licensing agreements	Maximize regional availability	Expand sales footprint
Invest in patient education	Improve adherence	Increase clearance rates
Innovate formulations	Reduce treatment duration	Appeal to prescribers & patients
Focus on niche markets	Immunocompromised, recurrent cases	Steady revenue streams

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Comparative Analysis of Key Candidates in HPV Wart Treatment Market

Factor	VEREGEN	Imiquimod	Podophyllotoxin	Cryotherapy
Approval Year	2006	1997	1960s	Established
Mode of Action	Catechins inhibit viral replication	Immune modulation	Cytotoxicity	Physical destruction
Treatment Course	16 weeks	4-16 weeks	1-4 weeks	Clinical visit required
Side Effects	Mild inflammation, allergic reactions	Erythema, itching	Discomfort	Pain, scarring
Patient Preference	Moderate	High	Variable	Low

Conclusion: VEREGEN maintains a niche appeal but faces market challenges due to longer therapy duration and competition.

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Key Takeaways

• Market Niche: VEREGEN remains relevant primarily in patients seeking non-invasive, topical HPV wart treatment, especially where immune response modulation is desired.
• Patent and Competition: Patent expiry in 2012 precipitated generic entry, exerting price pressures; sustained growth depends on regional expansion and formulation improvements.
• Growth prospects: Moderate, with limited upside unless innovative delivery systems or indications are explored.
• Regional strategies: Targeted expansion into emerging markets and underpenetrated regions could bolster sales.
• Competitive positioning: Differentiation through efficacy, safety profile, and patient convenience is crucial given intense competition from immune-modulating agents and physical therapies.
• Technological and policy influences: Innovation and healthcare policy shifts toward cost efficiency will shape future trajectories; ongoing R&D and partnerships are vital.

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FAQs

1. Is VEREGEN’s market expected to grow in the next five years?
While the overall pressure from generic competition constrains rapid growth, targeted regional expansion and formulation innovations could foster modest increases, projecting sales stabilizing around $50 million by 2027.

2. How does patent expiration impact VEREGEN’s profitability?
Patent expiry in 2012 facilitated generic entry, leading to significant price erosion and reduced margins. Future profitability hinges on strategic alliances, niche market focus, and potential new indications.

3. Are there upcoming competitors that threaten VEREGEN’s market share?
Yes. Advances in immunotherapies, topical formulations, and minimally invasive devices — including laser treatments and gene therapies — could further displace VEREGEN unless it adapts through innovation.

4. What regional strategies could maximize VEREGEN’s sales?
Tailored approaches such as licensing agreements, educational campaigns, and adherence programs can penetrate emerging markets, where awareness and healthcare infrastructure are evolving.

5. Could VEREGEN’s indications expand beyond HPV-related warts?
Potential exists—clinical trials exploring other viral or dermatological indications could diversify revenue streams, but such pathways require substantial investment and regulatory approval.

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References

1. Centers for Disease Control and Prevention (CDC). (2022). “Genital HPV Infection.”
2. World Health Organization (WHO). (2021). “Global HPV Epidemiology.”
3. FDA. (2006). “VEREGEN (Sinecatechins) Approval Document.”
4. Patent and Market Data Reports. (2018). “Pharmaceutical Patent Expirations and Generic Entry,” IQVIA.