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VEREGEN Drug Patent Profile

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When do Veregen patents expire, and when can generic versions of Veregen launch?

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

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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

Drug patent expirations by year for VEREGEN

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

Generic Entry Date for VEREGEN^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
National Cancer Institute (NCI)	Phase 2
ECOG-ACRIN Cancer Research Group	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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VEREGEN is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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

Medicament for the treatment of viral skin and tumour diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF GENITAL WARTS

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Glossary

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

Expired US Patents for VEREGEN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	⤷ Try a Trial	⤷ Try a Trial
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VEREGEN

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2289506		⤷ Try a Trial
Japan	3213557		⤷ Try a Trial
Brazil	PI0214256	medicamento	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VEREGEN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2055300	132016000077885	Italy	⤷ Try a Trial	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	488	Finland	⤷ Try a Trial
1448186	CA 2012 00040	Denmark	⤷ Try a Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description