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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 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. One supplier is 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: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| 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 |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| GTO Pharmaceutical, LLC | Phase 4 |
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 | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | Try Before You Buy | Try Before You Buy |
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VEREGEN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1108882 | Try Before You Buy |
| Australia | 4443897 | Try Before You Buy |
| European Patent Office | 1448186 | Try Before You Buy |
| China | 1323660 | Try Before You Buy |
| Australia | 2002356673 | Try Before You Buy |
| Argentina | 037526 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VEREGEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0842660 | 12C0077 | France | Try Before You Buy | 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 |
| 2055300 | C201600002 | Spain | Try Before You Buy | PRODUCT NAME: EXTRACTO SECO DE CAMELIA SINENSIS (L) O. KUNTZE FOLIUM (HOJA DE TE VERDE) CORRESPONDIENTE A GALATO DE (-)-EPIGALOCATEQUINA (EGCG).; NATIONAL AUTHORISATION NUMBER: 71435; DATE OF AUTHORISATION: 20110208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 73486.00.00; DATE OF FIRST AUTHORISATION IN EEA: 20090831 |
| 0842660 | C300581 | Netherlands | Try Before You Buy | PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831 |
| 1448186 | 140 5025-2012 | Slovakia | Try Before You Buy | PRODUCT NAME: PURIFIKOVANY SUCHY EXTRAKT ZO ZELENEHO CAJU (CAMELLIA SINENSIS (L.) O. KUNTZE) A IZOPROPYLMYRISTAT; NAT. REGISTRATION NO/DATE: 46/0306/12-S 20120716; FIRST REGISTRATION: DE 73486.00.00 20090831 |
| 1448186 | 300550 | Netherlands | Try Before You Buy | 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 |
| 1448186 | 488 | Finland | Try Before You Buy | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
