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:	5
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
National Cancer Institute (NCI)	Phase 2
ECOG-ACRIN Cancer Research Group	Phase 2
Hospital Universitari Vall d'Hebron Research Institute	Phase 3

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	9,770,406		Y
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes	7,858,662		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	5,795,911
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,968,973

International Patents for SINECATECHINS

Country	Patent Number	Title	Estimated Expiration
Germany	50213137
Hong Kong	1131048
Japan	2005514358
Mexico	PA04004532	MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES TUMORALES Y VIRALES DE LA PIEL. (MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES.)
Australia	2002356673
Spain	2569395
South Korea	100956369

Supplementary Protection Certificates for SINECATECHINS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1448186	140 5025-2012	Slovakia		PRODUCT NAME: PURIFIKOVANY SUCHY EXTRAKT ZO ZELENEHO CAJU (CAMELLIA SINENSIS (L.) O. KUNTZE) A IZOPROPYLMYRISTAT; NAT. REGISTRATION NO/DATE: 46/0306/12-S 20120716; FIRST REGISTRATION: DE 73486.00.00 20090831
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	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
1448186	C01448186/01	Switzerland		FORMER OWNER: MEDIGENE AG, DE
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	12C0058	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: NL41799 20120625; FIRST REGISTRATION: DE - 73186.00.00 20090831
1448186	2012C/051	Belgium		PRODUCT NAME: MELANGE DE CATECHOLS ISOLES D'UN EXTRAIT DE THE (CAMELLIA SINENSIS (L.) O. KUNTZE) AVEC DU MYRISTATE D'ISOPROPYLE; AUTHORISATION NUMBER AND DATE: BE424383 20120719

SINECATECHINS Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Sinecatechins in Genital Warts Treatment

Introduction

Sinecatechins, a topical treatment for external genital and perianal warts (condylomata acuminata), have been a significant player in the genital warts treatment market. This article delves into the market dynamics and financial trajectory of sinecatechins, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Size and Growth

The global genital warts treatment market, which includes sinecatechins, is projected to experience steady growth. As of 2024, the market is valued at USD 1.91 billion and is expected to reach USD 2.72 billion by 2031, growing at a compound annual growth rate (CAGR) of 5.2%[1].

Cost-Effectiveness of Sinecatechins

A key factor driving the adoption of sinecatechins is its cost-effectiveness compared to other treatments. A cost-effectiveness analysis revealed that sinecatechins yield a lower cost of treatment compared to imiquimod, another commonly used topical therapy. The average cost of treatment with sinecatechins is $774, which is lower than the $930 for imiquimod. Additionally, the cost per successful outcome with sinecatechins is $1,492, compared to $2,289 for imiquimod[2].

Market Segmentation

Sinecatechins fall under the category of topical treatments in the genital warts market. The market is segmented by drug type, with sinecatechins being one of the prominent options alongside imiquimod, podophyllin, podofilox, and trichloroacetic acid (TCA)[3].

Regional Performance

North America currently dominates the genital warts treatment market, including the segment for sinecatechins, due to advanced healthcare infrastructure and higher awareness levels. However, the Asia Pacific region is expected to witness the fastest growth over the forecast period, driven by improved access to healthcare in developing countries[1].

Growth Drivers

Several factors are driving the growth of the sinecatechins market:

• Increasing Awareness: Public awareness campaigns about sexually transmitted diseases (STDs) and the availability of effective treatments are boosting demand[1].
• Emerging Healthcare Infrastructure: Developing healthcare infrastructure in emerging nations is increasing access to treatments like sinecatechins[1].
• Novel Therapies: Pharmaceutical companies are investing in research and development of novel non-invasive therapies, which includes advancements in sinecatechins[1].

Challenges

Despite the growth drivers, there are challenges that could impact the market:

• Social Stigma: The social stigma associated with genital warts can reduce the willingness of patients to seek treatment[1].
• Preference for Non-Drug Therapies: Some patients prefer non-drug therapies, which can affect the demand for sinecatechins[1].
• High Cost of Treatment: Although sinecatechins are cost-effective compared to some other treatments, the overall cost of treatment for genital warts remains high, which can be a barrier[1].

Competitive Landscape

The market for genital warts treatment, including sinecatechins, is competitive with several key players:

• Verrica Pharmaceuticals
• Novan Inc.
• Tamir Biotechnology (Orgenesis)
• Merck & Co., Inc.
• Sanofi S.A. These companies are continuously innovating and developing new treatments, which can influence the market share of sinecatechins[1][4].

Product Launches and Innovations

In 2014, Paladin Labs Inc., a subsidiary of Endo International plc, launched Veregen (sinecatechins) Ointment, 10%, a topical treatment for external genital and perianal warts. Such launches and continuous innovation in the healthcare sector have increased consumer awareness and investments in medical infrastructure, benefiting the sinecatechins market[4].

Future Prospects

The future of sinecatechins looks promising due to several factors:

• Emergence of New Therapies: The anticipated introduction of novel medications and the development of new therapies will continue to drive the market[4].
• Global Health Initiatives: Effective vaccination campaigns and global health initiatives are raising public awareness and reducing the incidence of genital warts, which in turn can increase the demand for treatments like sinecatechins[4].
• Technological Innovations: Advancements in treatment technologies, including the rise of telemedicine and digital health solutions, are expected to enhance the accessibility and effectiveness of sinecatechins[3].

Key Takeaways

• Cost-Effectiveness: Sinecatechins offer a lower cost of treatment compared to other topical therapies like imiquimod.
• Market Growth: The global genital warts treatment market, including sinecatechins, is expected to grow at a CAGR of 5.2% from 2024 to 2031.
• Regional Growth: Asia Pacific is expected to be the fastest-growing region for genital warts treatment.
• Innovations: Continuous innovation and the launch of new therapies are driving the market forward.
• Challenges: Social stigma and high treatment costs remain significant challenges.

FAQs

What is the current market size of the genital warts treatment market?

The global genital warts treatment market is estimated to be valued at USD 1.91 billion in 2024[1].

How does sinecatechins compare to imiquimod in terms of cost-effectiveness?

Sinecatechins are more cost-effective than imiquimod, with an average treatment cost of $774 compared to $930 for imiquimod. The cost per successful outcome with sinecatechins is also lower, at $1,492 versus $2,289 for imiquimod[2].

Which region is expected to dominate the genital warts treatment market?

North America currently dominates the market, but the Asia Pacific region is expected to witness the fastest growth over the forecast period[1].

What are the key growth drivers for the sinecatechins market?

Key growth drivers include increasing awareness about STDs, emerging healthcare infrastructure, and the development of novel non-invasive therapies[1].

What challenges might affect the demand for sinecatechins?

Challenges include social stigma associated with genital warts, preference for non-drug therapies, and the high cost of treatment[1].

Sources

1. Coherent Market Insights: Genital Warts Treatment Market - Price, Size, Share & Growth.
2. PubMed: A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts.
3. Research and Markets: Condyloma Acuminata Treatment Global Market Report 2024.
4. PharmiWeb: Global Genital Warts (Condyloma Acuminatum) Market is expected to soar to US$ 3 Billion by 2033.