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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 Fougera Pharms Inc and is included in one NDA. There are three 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: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | sinecatechins at DailyMed |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Fougera Pharms Inc | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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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 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for 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.
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International Patents for sinecatechins
| Country | Document Number | Estimated Expiration |
|---|---|---|
| China | 1589141 | ➤ Sign Up |
| Hong Kong | 1131048 | ➤ Sign Up |
| China | 1086290 | ➤ Sign Up |
| Russian Federation | 2302861 | ➤ Sign Up |
| Germany | 69732402 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for sinecatechins
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0077 | France | ➤ Sign Up | 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 |
| 8 | Finland | ➤ Sign Up | |
| 00581 | Netherlands | ➤ Sign Up | PRODUCT NAME: DROOG EXTRACT VAN GROENE THEE; NAT. REGISTRATION NO/DATE: RVG 110904 20120917; FIRST REGISTRATION: 73486.00.00 20090831 |
| C/GB15/042 | United Kingdom | ➤ Sign Up | 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 |
| 90030-4 | Sweden | ➤ Sign Up | PRODUCT NAME: TORRT EXTRAKT AV CAMELLIA SINENSIS (L.) O. KUNTZE, FOLIUM; NAT. REG. NO/DATE: 47136 20120405; FIRST REG.: DE 73486.00.00 20090831 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
