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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Healthtrust
Colorcon
US Department of Justice
Chubb
Baxter
Moodys
Chinese Patent Office

Generated: August 20, 2018

DrugPatentWatch Database Preview

Sinecatechins - Generic Drug Details

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What are the generic drug sources for sinecatechins and what is the scope of sinecatechins 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 three 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
International Patents:44
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:sinecatechins at DailyMed

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fougera Pharms Inc VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fougera Pharms Inc VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for sinecatechins

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,968,973 Method for treating hyperplasia ➤ Sign Up
6,197,808 Methods for treating hyperplasia ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for sinecatechins

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0077 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: NL 41799 20120625; FIRST REGISTRATION: 73486.00.00 20090831
8 Finland ➤ Sign Up
00581 Netherlands ➤ Sign Up PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831
C/GB15/042 United Kingdom ➤ Sign Up PRODUCT NAME: DRY EXTRACT FROM CAMELLIA SINENSIS (L.) O.KUNTZE FOLIUM (GREEN TEA LEAVES) CORRESPONDING TO (-)-EPIGALLOCATECHIN GALLATE; REGISTERED: DE 73486.00.00 20090831; UK PL39972/0003 20150324
90030-4 Sweden ➤ Sign Up PRODUCT NAME: TORRT EXTRAKT AV CAMELLIA SINENSIS (L.) O. KUNTZE, FOLIUM; NAT. REG. NO/DATE: 47136 20120405; FIRST REG.: DE 73486.00.00 20090831
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Johnson and Johnson
Mallinckrodt
US Department of Justice
Covington
Fuji
Colorcon
Healthtrust
Queensland Health

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