Sinecatechins - Generic Drug Details

What are the generic sources for sinecatechins and what is the scope of patent protection?

Sinecatechins is the generic ingredient in one branded drug marketed by Ani Pharms and is included in one NDA. There are three 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. Two suppliers are listed for this compound.

Summary for sinecatechins

International Patents:	31
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	2
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

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

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			Y
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes			Y
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes			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
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006

International Patents for sinecatechins

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1073788
South Korea	100956369
Mexico	PA04004532	MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES TUMORALES Y VIRALES DE LA PIEL. (MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES.)
Israel	161625	MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES

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
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
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	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