Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

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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
International Patents:44
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Clinical Trials: 4
DailyMed Link:sinecatechins at DailyMed
Recent Clinical Trials for sinecatechins

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SponsorPhase
Hospital Universitari Vall d'Hebron Research InstitutePhase 3
GTO Pharmaceutical, LLCPhase 4
Maastricht University Medical CenterPhase 2/Phase 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   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 CA 2012 00040 Denmark   Start Trial
1448186 29/2010 Austria   Start Trial PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
AstraZeneca
Baxter
Moodys
Medtronic

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