VEREGEN Drug Patent Profile
✉ Email this page to a colleague
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 |



DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VEREGEN
Generic Entry Date for VEREGEN*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Anatomical Therapeutic Chemical (ATC) Classes for VEREGEN
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
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
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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2004118667 | ⤷ Try a Trial | |
China | 1589141 | ⤷ Try a Trial | |
Spain | 2232849 | ⤷ Try a Trial | |
Japan | 4495459 | ⤷ Try a Trial | |
Australia | 716120 | ⤷ Try a Trial | |
South Korea | 20050044344 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VEREGEN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0842660 | 12C0077 | France | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831 |
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 | 2012C/051 | Belgium | ⤷ Try a Trial | 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 | ⤷ Try a Trial | FORMER OWNER: MEDIGENE AG, DE |
1448186 | C300550 | Netherlands | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |