VEREGEN Drug Patent Profile

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

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	5,968,973

International Patents for VEREGEN

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1448186
Brazil	0214256
Japan	4495459

Supplementary Protection Certificates for VEREGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0842660	SPC/GB15/042	United Kingdom		PRODUCT NAME: DRY EXTRACT FROM CAMELLIA SINENSIS (L.) O.KUNTZE FOLIUM (GREEN TEA LEAVES) CORRESPONDING TO (-)-EPIGALLOCATECHIN GALLATE; REGISTERED: DE 73486.00.00 20090831; UK PL39972/0003 20150324
1448186	300550	Netherlands		PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE (CAMELLIA SINENSIS (L.) O.KUNZE FOLIUM) WATERIG (24-56:1) WAARVAN 100 MG OVEREENKOMT MET : 55-72 MG VAN (-)- EPIGALLOCATECHINEGALLAAT. EERSTE EXTRACTIEMIDDEL: WATER; NATIONAL REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831

Market Dynamics and Financial Trajectory for VEREGEN

Last updated: July 27, 2025

Introduction

VEREGEN (mosquito leaf extract, or sinecatechins) is an FDA-approved topical immunomodulator used predominantly for the treatment of external genital warts caused by human papillomavirus (HPV). Since its approval in 2006, VEREGEN has carved a niche within the dermatology and gynecology markets. Analyzing its market dynamics and projecting its financial trajectory entails understanding its clinical profile, competitive positioning, market adoption, and broader health economic considerations.

Market Overview

Therapeutic Indication and Clinical Profile

VEREGEN is indicated for the treatment of external genital and perianal warts (condylomata acuminata). Its mechanism involves stimulating the immune system to combat HPV-infected cells. The topical application regimen typically involves thrice-weekly treatments over a period of up to 16 weeks, with efficacy rates around 50-60%, according to clinical trials ([1]).

Despite its niche indication, VEREGEN faces competition from other treatment modalities such as cryotherapy, surgical excision, and topical agents like imiquimod and podophyllotoxins. The preference for VEREGEN hinges on its favorable side-effect profile and non-invasive application, appealing for patients with multiple or recurrent warts.

Market Penetration and Adoption Factors

VEREGEN’s adoption is influenced by several factors:

• Physician Prescribing Habits: U.S. clinical guidelines recognize VEREGEN as an alternative for patients intolerant of or unresponsive to other therapies, but its market share remains limited by physician familiarity and comfort with traditional methods.
• Patient Preferences: Patients seeking non-invasive, painless treatments often prefer VEREGEN, potentially driving incremental growth.
• Cost and Insurance Coverage: As with many dermatologic agents, reimbursement policies greatly impact market adoption. VEREGEN's relatively high cost and variable insurance coverage restrict widespread use ([2]).

Regulatory and Patent Landscape

VEREGEN benefits from exclusivity provided by patent protections, though the patent landscape is complex, with potential generic entries upon patent expiry. The expiration window influences future revenue streams and market competition.

Market Dynamics

Market Size and Segmentation

The global market for HPV-related treatments was valued at approximately USD 800 million in 2020, with top markets including the United States, Europe, and Japan. Genital warts account for a significant portion, with an estimated prevalence of 1% of sexually active adults ([3]).

VEREGEN specifically targets patients with genital warts seeking non-invasive therapy. Its addressable market, therefore, comprises millions of affected individuals, though actual prescription figures are lower, constrained by diagnosis rates and treatment preferences.

Competitive Landscape

Key competitors encompass:

• Imiquimod (Aldara): An immune response modifier, often first-line therapy.
• Podophyllotoxins (Podofilox): An outpatient topical agent.
• Cryotherapy/Surgical Methods: Procedural interventions with high efficacy but higher discomfort and risk.

While VEREGEN offers non-invasive administration, it struggles with higher cost and longer treatment durations compared to some alternatives.

Market Drivers

• Growing awareness of HPV-related diseases and increased screening.
• Patient preference shifts toward non-invasive outpatient therapies.
• Expanding healthcare access and insurance coverage in developed markets.

Market Challenges

• Limited awareness among physicians and patients.
• Preference for traditional treatments with immediate results.
• Cost barriers limiting widespread adoption.
• Potential for patent expiration and competition from generics.

Financial Trajectory and Revenue Outlook

Historical Performance

Since its launch, VEREGEN's revenues have grown modestly, primarily within the U.S. market. According to IQVIA data, annual sales ranged between USD 80-120 million globally, with the U.S. accounting for approximately 70-80% of sales ([4]).

Forecasting Future Revenue

The financial outlook hinges on:

• Market Penetration: With an estimated addressable market of approximately 10-15 million patients in the U.S. with genital warts, even a conservative 2-3% penetration offers substantial revenue potential.

• Product Lifecycle Dynamics: Patent exclusivity extensions or new formulations could prolong revenue windows. Conversely, patent expiry could introduce generics, pressuring prices and margins.

• Regulatory and Reimbursement Changes: Favorable policies could enhance adoption, whereas restrictive reimbursement could limit growth.

• Product Line Extensions: Potential development of formulations for other dermatologic indications (e.g., common warts) could expand market reach.

Revenue Projections (2023-2030)

Assuming modest annual growth rates of 3-5% driven by increased awareness and stable reimbursement policies, global revenues could approach USD 150-200 million annually by 2030. Market expansion into emerging markets remains limited due to regulatory hurdles and distribution challenges but could contribute incremental growth if addressed.

Factors Influencing Financial Trajectory

• Patent Cliff: The imminent expiration of patent rights could lead to revenue erosion unless new formulations or indications are developed.
• Market Expansion: Entry into additional indications aligned with immunomodulatory mechanisms could diversify revenue streams.
• Competitive Pressures: Launch of superior or more cost-effective therapies may curtail demand.

Regulatory and Market Access Considerations

A pivotal aspect of VEREGEN’s future financial performance depends on regulatory dynamics. Expanding indications or obtaining reimbursement approvals in various markets enhance revenue potential. Conversely, regulatory hurdles or unfavorable health technology assessments could impede growth.

Emerging Trends and Strategic Opportunities

Innovations such as combination therapies, novel formulations, or repositioning for other HPV-related conditions could redefine VEREGEN’s market position. Strategic partnerships with healthcare providers and payers are crucial to optimize market access.

Conclusion

VEREGEN operates within a specialized yet competitive segment of dermatological therapeutics. Its market dynamics reflect a blend of clinical efficacy, patient and physician preferences, cost considerations, and regulatory factors. While current revenues display modest growth, targeted strategies addressing reimbursement, awareness, and indication expansion can influence its financial trajectory positively over the next decade.

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Key Takeaways

• VEREGEN’s niche role in HPV-related wart treatment offers stable, albeit limited, revenue potential.
• Market expansion depends heavily on physician awareness, patient preferences, reimbursement policies, and patent exclusivity.
• Competitive pressures from alternative treatments and generic entrants pose risks to the long-term revenue outlook.
• Strategic development of new indications, formulations, or combination therapies could incrementally improve financial performance.
• Consistent engagement with regulatory agencies and payer stakeholders remains critical to maximizing market access and revenue growth.

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FAQs

1. What is the primary clinical advantage of VEREGEN over traditional therapies?
VEREGEN's non-invasive, topical immunomodulatory approach offers a painless treatment with fewer side effects, appealing to patients undergoing repeat or recurrent wart treatments.

2. How does VEREGEN fare in terms of treatment efficacy?
Clinical trials report an efficacy rate of approximately 50-60% for clearance of external genital warts, which is comparable to other topical agents but lower than procedural options like cryotherapy.

3. What are the main barriers to VEREGEN’s wider adoption?
High treatment costs, limited insurance reimbursement, physician familiarity, and competition from established therapies hinder broader market penetration.

4. Are there opportunities for VEREGEN to expand into other indications?
Potential exists for extension into other HPV-related conditions, such as common warts or anal intraepithelial neoplasia, pending clinical validation and regulatory approval.

5. How might patent expiration impact VEREGEN’s revenue?
Patent expiry could lead to generic competition, reducing prices and market share unless new formulations or indications sustain its commercial viability.

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Sources

[1] Food and Drug Administration (FDA). VEREGEN® (Sinecatechins) Prescribing Information. 2006.
[2] IQVIA. Market Intelligence Reports. 2022.
[3] Centers for Disease Control and Prevention (CDC). Genital Warts. 2021.
[4] Industry Sales Data, IQVIA, 2022.