Sinecatechins - Generic Drug Details
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What are the generic sources for sinecatechins and what is the scope of patent protection?
Sinecatechins
is the generic ingredient in one branded drug marketed by Ani Pharms and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for sinecatechins
| International Patents: | 31 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| 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
| Sponsor | Phase |
|---|---|
| Aresus Pharma GmbH | PHASE3 |
| National Cancer Institute (NCI) | Phase 2 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for sinecatechins
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 | 7,858,662 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >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 | 10,434,059 | ⤷ Start Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | 9,770,406 | ⤷ Start Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | 5,968,973 | ⤷ Start Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | 5,795,911 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sinecatechins
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 037526 | MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES VIRALES DE LA PIEL Y DE TUMORES | ⤷ Start Trial |
| Austria | 417611 | ⤷ Start Trial | |
| Australia | 2002356673 | ⤷ Start Trial | |
| Brazil | 0214256 | ⤷ Start Trial | |
| Brazil | PI0214256 | medicamento | ⤷ Start Trial |
| Canada | 2466720 | MEDICAMENT POUR TRAITER DES MALADIES DE PEAU VIRALES ET DES MALADIES TUMORALES (MEDICAMENT FOR THE TREATMENT OF VIRAL SKIN AND TUMOUR DISEASES) | ⤷ Start Trial |
| China | 1323660 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sinecatechins
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1448186 | C01448186/01 | Switzerland | ⤷ Start Trial | FORMER OWNER: MEDIGENE AG, DE |
| 2055300 | 132016000077885 | Italy | ⤷ Start Trial | 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 | ⤷ Start Trial | 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 | 300550 | Netherlands | ⤷ Start Trial | 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 |
| 1448186 | CA 2012 00040 | Denmark | ⤷ Start Trial | |
| 1448186 | 2012C/051 | Belgium | ⤷ Start Trial | PRODUCT NAME: MELANGE DE CATECHOLS ISOLES D'UN EXTRAIT DE THE (CAMELLIA SINENSIS (L.) O. KUNTZE) AVEC DU MYRISTATE D'ISOPROPYLE; AUTHORISATION NUMBER AND DATE: BE424383 20120719 |
| 1448186 | 488 | Finland | ⤷ Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
