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VEREGEN Drug Profile

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Which patents cover Veregen, and what generic alternatives are available?

Veregen is a drug marketed by Fougera Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four 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.

Summary for VEREGEN

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	6
Drug Prices:	see details
DailyMed Link:	VEREGEN at DailyMed

US Patents and Regulatory Information for VEREGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms Inc	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes
Fougera Pharms Inc	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes			Y
Fougera Pharms Inc	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006		RX	Yes	Yes			Y

Expired US Patents for VEREGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms Inc	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006

Non-Orange Book US Patents for VEREGEN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
5,968,973	Method for treating hyperplasia
6,197,808	Methods for treating hyperplasia

International Patents for VEREGEN

Country	Document Number	Estimated Expiration
Canada	2466720
Australia	716120
South Korea	20050044344
China	1589141

Supplementary Protection Certificates for VEREGEN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0842660/01	Switzerland		PRODUCT NAME: CAMELLIAE SINENSIS EXTRACTUM SICCUM RAFFINATUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 61895 27.03.2012
0550	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
2012 00040	Denmark
90030-4	Sweden		PRODUCT NAME: TORRT EXTRAKT AV CAMELLIA SINENSIS (L.) O. KUNTZE, FOLIUM; NAT. REG. NO/DATE: 47136 20120405; FIRST REG.: DE 73486.00.00 20090831