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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 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 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sinecatechins |
| DailyMed Link: | sinecatechins at DailyMed |
Recent Clinical Trials for sinecatechins
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hospital Universitari Vall d'Hebron Research Institute | Phase 3 |
| GTO Pharmaceutical, LLC | Phase 4 |
| Will-Pharma | Phase 2/Phase 3 |
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 | ||||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | Start Trial | 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 |
|---|---|---|---|---|---|---|---|
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for sinecatechins
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100956369 | Start Trial |
| Japan | 4495459 | Start Trial |
| Spain | 2569395 | Start Trial |
| Hong Kong | 1131048 | Start Trial |
| Germany | 122009000073 | Start Trial |
| Portugal | 842660 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sinecatechins
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0842660 | SPC/GB15/042 | United Kingdom | Start Trial | 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 | 488 | Finland | Start Trial | |
| 1448186 | 132016000031245 | 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): ITALIA NO. 043866019 E 043866021, 20150928;NO. 73486.00.00, 20090907 |
| 1448186 | C01448186/01 | Switzerland | Start Trial | FORMER OWNER: MEDIGENE AG, DE |
| 1448186 | CA 2012 00040 | Denmark | Start Trial | |
| 0842660 | 12C0077 | 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: NL 41799 20120625; FIRST REGISTRATION: 73486.00.00 20090831 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
