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Generated: October 16, 2017
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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 1 |
| Suppliers / Packagers: see list | 1 |
| Clinical Trials: see list | 2 |
| Therapeutic Class: | Dermatological Agents |
| Drug Prices: | see low prices |
| DailyMed Link: | sinecatechins at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medigene Ag | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
Medigene Ag | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Medigene Ag | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medigene Ag | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ► Subscribe | ► Subscribe | ||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | PI0214256 | ► Subscribe | |||||||||||||
| Russian Federation | 2302861 | ► Subscribe | |||||||||||||
| Brazil | 0214256 | ► Subscribe | |||||||||||||
| South Africa | 200403287 | ► Subscribe | |||||||||||||
| South Korea | 100956369 | ► Subscribe | |||||||||||||
| Australia | 2002356673 | ► Subscribe | |||||||||||||
| European Patent Office | 0842660 | ► Subscribe | |||||||||||||
| Japan | 3213557 | ► Subscribe | |||||||||||||
| Germany | 122009000073 | ► Subscribe | |||||||||||||
| Canada | 2466720 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8 | Finland | ► Subscribe | |||||||||||||
| 00550 | Netherlands | ► Subscribe | 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 | ||||||||||||
| 0550 | Netherlands | ► Subscribe | 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 | ||||||||||||
| 2012 00040 | Denmark | ► Subscribe | |||||||||||||
| 00581 | Netherlands | ► Subscribe | PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831 | ||||||||||||
| 0842660/01 | Switzerland | ► Subscribe | PRODUCT NAME: CAMELLIAE SINENSIS EXTRACTUM SICCUM RAFFINATUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 61895 27.03.2012 | ||||||||||||
| 90030-4 | Sweden | ► Subscribe | PRODUCT NAME: TORRT EXTRAKT AV CAMELLIA SINENSIS (L.) O. KUNTZE, FOLIUM; NAT. REG. NO/DATE: 47136 20120405; FIRST REG.: DE 73486.00.00 20090831 | ||||||||||||
| 0 5025-2012 | Slovakia | ► Subscribe | 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 | ||||||||||||
| C/GB15/042 | United Kingdom | ► Subscribe | 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 | ||||||||||||
| 1448186/01 | Switzerland | ► Subscribe | FORMER OWNER: MEDIGENE AG, DE | ||||||||||||
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Serving leading biopharmaceutical companies globally:
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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