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. One supplier is 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: | 1 |
| 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
*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 |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| ECOG-ACRIN Cancer Research Group | Phase 2 |
| Hospital Universitari Vall d'Hebron Research Institute | Phase 3 |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | VEREGEN | sinecatechins | OINTMENT;TOPICAL | 021902-001 | Oct 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Ani Pharms | 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 |
International Patents for sinecatechins
Supplementary Protection Certificates for sinecatechins
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1448186 | 12C0058 | 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: NL41799 20120625; FIRST REGISTRATION: DE - 73186.00.00 20090831 |
| 1448186 | C01448186/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: MEDIGENE AG, DE |
| 1448186 | CA 2012 00040 | Denmark | ⤷ Sign Up | |
| 1448186 | 140 5025-2012 | Slovakia | ⤷ Sign Up | 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 |
| 1448186 | 132016000031245 | Italy | ⤷ Sign Up | 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 | 29/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
