SINECATECHINS - Generic Drug Details
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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 Ani Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sinecatechins has thirty-one patent family members in twenty countries.
There is one drug master file entry for sinecatechins. Two suppliers are listed for this compound.
Summary for SINECATECHINS
| International Patents: | 31 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 5 |
| 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 |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
| Hospital Universitari Vall d'Hebron Research Institute | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SINECATECHINS
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 4495459 | ⤷ Try a Trial | |
| Hong Kong | 1073788 | ⤷ Try a 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) | ⤷ Try a Trial |
| Germany | 122009000073 | ⤷ Try a Trial | |
| Austria | 417611 | ⤷ Try a Trial | |
| Portugal | 1448186 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SINECATECHINS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2055300 | 132016000077885 | Italy | ⤷ Try a 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 | CR 2012 00040 | Denmark | ⤷ Try a Trial | PRODUCT NAME: EN BLANDING AF CATECHINER ISOLERET FRA ET EKSTRAKT AF GROEN TE (CAMELLIA SINENSIS (L.) O. KUNTTZE) , HERUNDER (-)-EPIGALLOCATECHINGALLAT; NAT. REG. NO/DATE: 49803 (DK) 20120702; FIRST REG. NO/DATE: DE 73486.00.00 20090831 |
| 1448186 | C01448186/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: MEDIGENE AG, DE |
| 1448186 | C300550 | Netherlands | ⤷ Try a Trial | 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 |
| 2055300 | C201600002 | Spain | ⤷ Try a Trial | PRODUCT NAME: EXTRACTO SECO DE CAMELIA SINENSIS (L) O. KUNTZE FOLIUM (HOJA DE TE VERDE) CORRESPONDIENTE A GALATO DE (-)-EPIGALOCATEQUINA (EGCG).; NATIONAL AUTHORISATION NUMBER: 71435; DATE OF AUTHORISATION: 20110208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 73486.00.00; DATE OF FIRST AUTHORISATION IN EEA: 20090831 |
| 1448186 | 132016000031245 | Italy | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
