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Sinecatechins - Generic Drug Details
What are the generic drug sources for sinecatechins and what is the scope of 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 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 |
| 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 |
| Maastricht University Medical Center | 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 | ||||
| >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 |
|---|---|---|
| Spain | 2319626 | Start Trial |
| Hong Kong | 1073788 | Start Trial |
| Brazil | PI0214256 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sinecatechins
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1448186 | CA 2012 00040 | Denmark | Start Trial | |
| 1448186 | 29/2010 | Austria | Start Trial | PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908 |
| 1448186 | 140 5025-2012 | Slovakia | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
