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Serving leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
Baxter
Julphar
QuintilesIMS
Mallinckrodt
Fish and Richardson
Dow
Cantor Fitzgerald
Express Scripts

Generated: December 12, 2017

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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 sinecatechins freedom to operate?

Sinecatechins
is the generic ingredient in one branded drug marketed by Medigene Ag 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 and thirteen supplementary protection certificates in eight countries.

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

Summary for sinecatechins

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Medigene AgVEREGENsinecatechinsOINTMENT;TOPICAL021902-001Oct 31, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Medigene AgVEREGENsinecatechinsOINTMENT;TOPICAL021902-001Oct 31, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Medigene AgVEREGENsinecatechinsOINTMENT;TOPICAL021902-001Oct 31, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Medigene AgVEREGENsinecatechinsOINTMENT;TOPICAL021902-001Oct 31, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sinecatechins

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medigene AgVEREGENsinecatechinsOINTMENT;TOPICAL021902-001Oct 31, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
6,197,808 Methods for treating hyperplasia► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: sinecatechins

Country Document Number Estimated Expiration
European Patent Office2055300► Subscribe
Germany122009000072► Subscribe
Hong Kong1073788► Subscribe
JapanH10147525► Subscribe
Spain2319626► Subscribe
Spain2232849► Subscribe
Israel161625► Subscribe
South Africa200403287► Subscribe
Canada2221370► Subscribe
South Korea100956369► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SINECATECHINS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0058France► SubscribePRODUCT 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
1448186/01Switzerland► SubscribeFORMER OWNER: MEDIGENE AG, DE
0842660/01Switzerland► SubscribePRODUCT NAME: CAMELLIAE SINENSIS EXTRACTUM SICCUM RAFFINATUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 61895 27.03.2012
0 5025-2012Slovakia► SubscribePRODUCT 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
8Finland► Subscribe
C/GB15/042United Kingdom► SubscribePRODUCT 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
0550Netherlands► SubscribePRODUCT 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
00550Netherlands► SubscribePRODUCT 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
00581Netherlands► SubscribePRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831
2012 00040Denmark► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Covington
Deloitte
UBS
Citi
Teva
Cantor Fitzgerald
Cipla
AstraZeneca
Argus Health
Johnson and Johnson

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 verifification 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.

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