Sinecatechins - Generic Drug Details

What are the generic drug 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for Sinecatechins

International Patents:	31
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	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

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

International Patents for Sinecatechins

Country	Patent Number	Title	Estimated Expiration
Argentina	037526	MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES VIRALES DE LA PIEL Y DE TUMORES
Austria	417611
Australia	2002356673
Brazil	0214256
Brazil	PI0214256	medicamento
Canada	2466720	MEDICAMENT POUR TRAITER DES MALADIES DE PEAU VIRALES ET DES MALADIES TUMORALES (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
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	488	Finland
1448186	C01448186/01	Switzerland		FORMER OWNER: MEDIGENE AG, DE
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
1448186	132016000031245	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): ITALIA NO. 043866019 E 043866021, 20150928;NO. 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