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VEREGEN Drug Patent Profile

When do Veregen patents expire, and what generic alternatives are available?

Veregen is a drug marketed by Ani Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty countries.

The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sinecatechins profile page.

DrugPatentWatch^® Generic Entry Outlook for Veregen

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEREGEN

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	8
Drug Prices:	Drug price information for VEREGEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VEREGEN
What excipients (inactive ingredients) are in VEREGEN?	VEREGEN excipients list
DailyMed Link:	VEREGEN at DailyMed

See drug prices for VEREGEN

See drug sales revenues for VEREGEN

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

NDA:

021902

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 VEREGEN

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

Sponsor	Phase
ECOG-ACRIN Cancer Research Group	Phase 2
National Cancer Institute (NCI)	Phase 2
GTO Pharmaceutical, LLC	Phase 2

See all VEREGEN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VEREGEN

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

US Patents and Regulatory Information for VEREGEN

VEREGEN is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VEREGEN

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

Expired US Patents for VEREGEN

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 VEREGEN

See the table below for patents covering VEREGEN around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2466720	MEDICAMENT POUR TRAITER DES MALADIES DE PEAU VIRALES ET DES MALADIES TUMORALES (MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES)
South Korea	20050044344
Canada	2221370	COMPOSITION POUR TRAITER LES CONDYLOMES ACUMINES (COMPOSITION FOR TREATING CONDYLOMA ACUMINATA)
Portugal	1448186
Germany	122009000073
China	1589141

Supplementary Protection Certificates for VEREGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
0842660	12C0077	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: NL 41799 20120625; FIRST REGISTRATION: 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
0842660	SPC/GB15/042	United Kingdom		PRODUCT NAME: DRY EXTRACT FROM CAMELLIA SINENSIS (L.) O.KUNTZE FOLIUM (GREEN TEA LEAVES) CORRESPONDING TO (-)-EPIGALLOCATECHIN GALLATE; REGISTERED: DE 73486.00.00 20090831; UK PL39972/0003 20150324