Sinecatechins - Generic Drug Details

What are the generic drug sources for sinecatechins and what is the scope of freedom to operate?

Sinecatechins is the generic ingredient in one branded drug marketed by Ani Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sinecatechins has thirty-one patent family members in twenty countries.

There is one drug master file entry for sinecatechins. One supplier is listed for this compound.

Summary for sinecatechins

International Patents:	31
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sinecatechins
What excipients (inactive ingredients) are in sinecatechins?	sinecatechins excipients list
DailyMed Link:	sinecatechins at DailyMed

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

Constraining patent/regulatory exclusivity:

5,795,911

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 sinecatechins

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

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

See all sinecatechins clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for sinecatechins

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for sinecatechins

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 sinecatechins

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
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,795,911

International Patents for sinecatechins

Country	Patent Number	Title	Estimated Expiration
Germany	50213137
Spain	2319626
Cyprus	1108882
Hong Kong	1073788
Argentina	037526	MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES VIRALES DE LA PIEL Y DE TUMORES
Spain	2569395

Supplementary Protection Certificates for sinecatechins

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
2055300	C201600002	Spain		PRODUCT NAME: EXTRACTO SECO DE CAMELIA SINENSIS (L) O. KUNTZE FOLIUM (HOJA DE TE VERDE) CORRESPONDIENTE A GALATO DE (-)-EPIGALOCATEQUINA (EGCG).; NATIONAL AUTHORISATION NUMBER: 71435; DATE OF AUTHORISATION: 20110208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 73486.00.00; DATE OF FIRST AUTHORISATION IN EEA: 20090831
1448186	488	Finland
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
1448186	29/2010	Austria		PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
1448186	CR 2012 00040	Denmark		PRODUCT NAME: EN BLANDING AF CATECHINER ISOLERET FRA ET EKSTRAKT AF GROEN TE (CAMELLIA SINENSIS (L.) O. KUNTTZE) , HERUNDER (-)-EPIGALLOCATECHINGALLAT; NAT. REG. NO/DATE: 49803 (DK) 20120702; FIRST REG. NO/DATE: DE 73486.00.00 20090831

Market Dynamics and Financial Trajectory for Sinecatechins: A Comprehensive Analysis

Last updated: July 27, 2025

Introduction

Sinecatechins, a topical formulation primarily approved for the treatment of external genital and perianal warts, represents a significant segment within the botanical drug market. Derived from green tea leaves (Camellia sinensis), sinecatechins harness the antioxidant properties of catechins, notably epigallocatechin gallate (EGCG). Regulatory approvals, amid an evolving landscape of antiviral therapies and burgeoning demand for natural health products, underpin the pharmacoeconomic potential of sinecatechins. This report examines the current market dynamics, regulatory considerations, competitive landscape, and the financial trajectory underpinning sinecatechins’ commercial prospects.

Market Overview and Demand Drivers

The global herbal and botanical drug market, valued at approximately USD 7.9 billion in 2022, is expected to expand at a compound annual growth rate (CAGR) of 7-9% over the next five years, driven by increasing consumer preference for natural remedies and expanding approval frameworks for botanical drugs[1]. Sinecatechins occupies a niche within this sector, approved by the U.S. Food and Drug Administration (FDA) under the trade name Veregen since 2006. Its efficacy profile and minimal side effects foster clinician confidence, particularly in dermatological and gynecological contexts.

The demand for sinecatechins is primarily influenced by:

• Prevalence of HPV-induced warts: Genital warts attributable to human papillomavirus (HPV) remain among the most common sexually transmitted infections globally, with an estimated 6.9 million cases annually in the U.S. alone[2]. Sinecatechins offers a non-invasive alternative to surgical options, bolstering patient compliance and expanding market penetration.
• Natural product preference: Increasing consumer inclination toward plant-based therapies supports sinecatechins' positioning as a natural antiviral therapy.
• Regulatory acknowledgment: Approval in major markets catalyzes physician adoption, further propelling usage.

Regulatory Landscape and Approvals

The FDA approved sinecatechins as a prescription topical medication for external genital and perianal warts, referencing its favorable safety and efficacy profile in multiple clinical trials. Additional regulatory pathways, such as the European Medicines Agency (EMA) and Chinese National Medical Products Administration (NMPA), are evaluating or have granted approvals under varying credentialing for botanical drugs, emphasizing the importance of regional regulatory alignments.

Potential future approvals for broader indications, such as oral or systemic antiviral therapies, would significantly alter market size and revenue potential, provided clinical trials substantiate such claims. Moreover, patent protections and exclusivity periods impact the competitive landscape and market share dynamics.

Competitive Landscape

Sinecatechins faces competition from conventional antiviral agents such as imiquimod, cryotherapy, and surgical procedures. While these treatments pose alternatives, sinecatechins' unique botanical origin and tolerability afford it competitive differentiation.

Emerging products leveraging advanced drug delivery systems or combining sinecatechins with other antiviral agents could threaten its market share. Furthermore, interest in natural and plant-derived compounds is increasing among pharmaceutical firms, which may lead to new entrants or repurposing of existing botanical formulations.

Market Challenges

Despite promising demand, several hindrances inhibit broader market expansion:

• Limited indications: Currently approved solely for genital warts, constraining revenue streams.
• Cost and reimbursement issues: High treatment costs and variable insurance coverage influence prescribing patterns.
• Market awareness: Education on sinecatechins’ benefits remains crucial, especially in regions where botanical drugs lack familiarity.
• Clinical evidence: While robust for genital warts, data supporting broader antiviral applications is limited, necessitating ongoing research.

Financial Trajectory and Revenue Projections

Sinecatechins’ financial outlook hinges on factors such as market penetration, regulatory developments, and the competitive environment. The following projections outline potential revenue trajectories:

• Market Penetration in the U.S.: Estimated at approximately USD 100 million annually since its launch. Assuming moderate growth of 2-4% annually with improving awareness and prescriber adherence, revenues could stabilize or modestly increase.
• Expansion Opportunities: If sinecatechins gains approval for additional indications—such as oral prophylaxis or treatment of other HPV-related conditions—market size could multiply severalfold, potentially reaching USD 500 million to USD 1 billion globally within a decade.
• Geographical Expansion: Entry into emerging markets like China and India, where there is a sizeable burden of HPV and increasing acceptance of botanical therapies, could yield significant growth, provided regulatory hurdles are navigated effectively.

Long-term profits will depend on manufacturing scalability, pricing strategies, and patent or exclusivity protections. The rising adoption of natural therapies and ongoing clinical research supporting sinecatechins’ versatility may enable early adopters to secure a competitive advantage. Licensing opportunities and strategic alliances could further accelerate revenue growth.

Key Market Drivers and Trends

• Natural and Holistic Approach: Rising consumer and clinician preference for plant-based treatments favors sinecatechins.
• Regulatory Pathways: Accelerated approval processes for botanical drugs in various jurisdictions streamline market entry.
• Clinical Evidence Expansion: Ongoing trials for systemic or combination therapies may enhance product value.
• Digital and Educational Campaigns: Increased marketing efforts to raise awareness and dispel misconceptions enhance adoption.

Risks and Uncertainties

• Regulatory Delays: Extended approval timelines or additional safety data requirements could delay commercial expansion.
• Market Competition: Technological advancements in antiviral treatments or generic formulations could reduce market share.
• Pricing and Reimbursement: High costs or limited insurance coverage restrict consumer access and sales.
• Clinical Data Limitations: Insufficient evidence for extra-indication approvals could constrain revenue potential.

Conclusion

Sinecatechins’ market dynamics are rooted in its botanical origin, proven clinical efficacy against HPV-induced genital warts, and evolving regulatory landscape favoring plant-based therapies. Its financial trajectory will depend on market penetration, regulatory expansions, and the development of additional indications. While current revenues remain modest, the compound’s potential for growth is substantial, particularly if future clinical trials demonstrate effectiveness in broader antiviral indications and geographical expansion is achieved.

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Key Takeaways

• Sinecatechins holds a unique position in the botanical antiviral market, with established FDA approval for genital warts.
• Growing consumer preference for natural treatments and supportive regulatory frameworks underpin its market potential.
• Expansion into new indications and geographies is critical for unlocking long-term revenue growth.
• Competitive challenges and regulatory hurdles necessitate strategic planning and ongoing clinical research.
• Investors and corporate strategists should monitor clinical development and regional approval trends to capitalize on emerging opportunities.

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Frequently Asked Questions

1. What is sinecatechins, and how does it differ from other HPV treatments?

Sinecatechins is a botanical topical medication derived from green tea leaves, approved for treating external genital and perianal warts caused by HPV. Unlike surgical or chemical treatments, it offers a non-invasive, natural alternative with a favorable safety profile, leveraging antioxidant properties to inhibit viral proliferation.

2. What are the key regulatory approvals influencing sinecatechins’ market?

The U.S. FDA approved sinecatechins as Veregen in 2006 for genital warts, establishing a regulatory framework. Other regions, including the EU and China, are evaluating or have approved similar botanical drugs, shaping its global market access and commercialization potential.

3. What are the growth prospects for sinecatechins in emerging markets?

Emerging markets with high HPV prevalence and increasing acceptance of botanical therapies, such as China and India, offer significant growth opportunities. Navigating local regulatory pathways and building clinical evidence will be critical for successful market entry.

4. How might future clinical research impact sinecatechins’ market share?

Positive results from trials investigating systemic antiviral effects or broader indications could expand its use, increase sales, and attract additional licensing deals, boosting overall market share and revenue streams.

5. What are the main challenges facing sinecatechins’ commercial expansion?

Challenges include limited approved indications, market competition, regulatory delays, pricing/reimbursement issues, and the need for extensive physician and consumer education to increase adoption.

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References

1. MarketWatch. "Global Botanical Drug Market Size & Trends." 2022.
2. CDC. "Genital Warts (Human Papillomavirus)." 2021.