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Last Updated: June 21, 2024

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 Ani Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sinecatechins has thirty-one patent family members in twenty countries.

There is one drug master file entry for sinecatechins. Two suppliers are listed for this compound.

Summary for SINECATECHINS
International Patents:31
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 2
Clinical Trials: 5
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for SINECATECHINS
What excipients (inactive ingredients) are in SINECATECHINS?SINECATECHINS excipients list
DailyMed Link:SINECATECHINS at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SINECATECHINS
Generic Entry Date for SINECATECHINS*:
Constraining patent/regulatory exclusivity:
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 SINECATECHINS

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

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 2
National Cancer Institute (NCI)Phase 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
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 SINECATECHINS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 ⤷  Sign Up ⤷  Sign Up
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 ⤷  Sign Up ⤷  Sign Up
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SINECATECHINS

Country Patent Number Title Estimated Expiration
European Patent Office 2289506 ⤷  Sign Up
China 1589141 ⤷  Sign Up
Denmark 1448186 ⤷  Sign Up
Russian Federation 2302861 ЛЕКАРСТВЕННОЕ СРЕДСТВО ДЛЯ ЛЕЧЕНИЯ ВИРУСНЫХ КОЖНЫХ И ОПУХОЛЕВЫХ ЗАБОЛЕВАНИЙ ⤷  Sign Up
Australia 2002356673 ⤷  Sign Up
Argentina 037526 MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES VIRALES DE LA PIEL Y DE TUMORES ⤷  Sign Up
Israel 161625 MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SINECATECHINS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1448186 29/2010 Austria ⤷  Sign Up PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
1448186 488 Finland ⤷  Sign Up
1448186 140 5025-2012 Slovakia ⤷  Sign Up 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 ⤷  Sign Up 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
2055300 132016000077885 Italy ⤷  Sign Up 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 12C0058 France ⤷  Sign Up PRODUCT NAME: EXTRAIT SEC RAFFINE DE FEUILLE DE THE VERT (CAMELLIA SINENSIS (L.) O. KUNTZE) QUANTIFIE EN GALLATE D'(-)-EPIGALLOCATECHINE; NAT. REGISTRATION NO/DATE: NL41799 20120625; FIRST REGISTRATION: DE - 73186.00.00 20090831
1448186 CR 2012 00040 Denmark ⤷  Sign Up PRODUCT NAME: EN BLANDING AF CATECHINER ISOLERET FRA ET EKSTRAKT AF GROEN TE (CAMELLIA SINENSIS (L.) O. KUNTTZE) , HERUNDER (-)-EPIGALLOCATECHINGALLAT; NAT. REG. NO/DATE: 49803 (DK) 20120702; FIRST REG. NO/DATE: DE 73486.00.00 20090831
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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