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VEREGEN Drug Profile
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» See Plans and PricingWhich 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 four patents protecting this drug.
This drug has forty-four 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.
US ANDA Litigation and 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: | 44 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| Drug Prices: | Drug price information for VEREGEN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VEREGEN |
| DailyMed Link: | VEREGEN at DailyMed |
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 |
|---|---|
| GTO Pharmaceutical, LLC | Phase 4 |
| University of Texas Southwestern Medical Center | Phase 4 |
| Medigene AG | Phase 2/Phase 3 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 |
|---|---|---|---|---|---|---|---|
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VEREGEN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 50213137 | Start Trial |
| Spain | 2569395 | Start Trial |
| Japan | 4495459 | Start Trial |
| European Patent Office | 0842660 | Start Trial |
| Russian Federation | 2302861 | Start Trial |
| Mexico | PA04004532 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VEREGEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1448186 | 2012C/051 | Belgium | Start 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 |
| 0842660 | 1290030-4 | Sweden | Start Trial | PRODUCT NAME: TORRT EXTRAKT AV CAMELLIA SINENSIS (L.) O. KUNTZE, FOLIUM; NAT. REG. NO/DATE: 47136 20120405; FIRST REG.: DE 73486.00.00 20090831 |
| 1448186 | 132016000031245 | Italy | Start 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): ITALIA NO. 043866019 E 043866021, 20150928;NO. 73486.00.00, 20090907 |
| 1448186 | 140 5025-2012 | Slovakia | Start Trial | 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 | C01448186/01 | Switzerland | Start Trial | FORMER OWNER: MEDIGENE AG, DE |
| 1448186 | C300550 | Netherlands | Start 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 |
