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Last Updated: December 5, 2020

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Sinecatechins - Generic Drug Details

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What are the generic drug sources for sinecatechins and what is the scope of freedom to operate?

Sinecatechins is the generic ingredient in one branded drug marketed by Fougera Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sinecatechins has forty-four patent family members in twenty countries.

There is one drug master file entry for sinecatechins. One supplier is listed for this compound.

Summary for sinecatechins
Recent Clinical Trials for sinecatechins

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Cancer Institute (NCI)Phase 2
ECOG-ACRIN Cancer Research GroupPhase 2
Hospital Universitari Vall d'Hebron Research InstitutePhase 3

See all sinecatechins clinical trials

US Patents and Regulatory Information for sinecatechins

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 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
Fougera Pharms Inc VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 RX Yes Yes   Start Trial   Start Trial   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 sinecatechins

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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
2055300 132016000077885 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): 043866019 - 43866021, 20150928;73486.00.00, 20090907
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Medtronic
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Johnson and Johnson

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