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Last Updated: July 5, 2020

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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 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

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Drug patent expirations by year for VEREGEN
Drug Prices for VEREGEN

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Drug Sales Revenue Trends for VEREGEN

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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

SponsorPhase
GTO Pharmaceutical, LLCPhase 4
University of Texas Southwestern Medical CenterPhase 4
Medigene AGPhase 2/Phase 3

See all VEREGEN clinical trials

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

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Baxter
McKesson
Medtronic
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.