VEREGEN Drug Patent Profile

Which patents cover Veregen, 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.

Annual sales in 2019 were $10mm indicating the motivation for generic entry (peak sales were $32mm in 2015).

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
Drug Sales Revenues:	Drug sales revenues 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
Russian Federation	2004118667
China	1589141
Spain	2232849
Japan	4495459
Australia	716120
South Korea	20050044344

Supplementary Protection Certificates for VEREGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0842660	C300581	Netherlands		PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831
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	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	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