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Telbivudine - Generic Drug Details
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What are the generic sources for telbivudine and what is the scope of patent protection?
Telbivudine
is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Telbivudine has sixty patent family members in twenty-one countries.
There are two drug master file entries for telbivudine.
Summary for telbivudine
International Patents: | 60 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Bulk Api Vendors: | 69 |
Clinical Trials: | 79 |
Patent Applications: | 3,280 |
Formulation / Manufacturing: | see details |
DailyMed Link: | telbivudine at DailyMed |
Recent Clinical Trials for telbivudine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Beijing Ditan Hospital | Phase 4 |
Sun Yat-sen University | Phase 2 |
National Medical Research Council (NMRC), Singapore | Phase 4 |
US Patents and Regulatory Information for telbivudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | DISCN | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | Start Trial | Start Trial | Y | 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 telbivudine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | Start Trial | Start Trial |
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | Start Trial | Start Trial |
Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | Start Trial | Start Trial |
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | Start Trial | Start Trial |
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for telbivudine
Country | Patent Number | Estimated Expiration |
---|---|---|
Taiwan | I244393 | Start Trial |
Spain | 2531928 | Start Trial |
South Korea | 20080032260 | Start Trial |
South Korea | 100691737 | Start Trial |
South Korea | 100702230 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for telbivudine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1104436 | 300286 | Netherlands | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
1104436 | 07C0046 | France | Start Trial | PRODUCT NAME: TELBIVUDINE (DC1); REGISTRATION NO/DATE IN FRANCE: EU/1/07/388/001 DU 20070424; REGISTRATION NO/DATE AT EEC: EU/1/07/388/001 DU 20070424 |
1104436 | CA 2007 00038 | Denmark | Start Trial | PRODUCT NAME: TELBIVUDINE |
1104436 | C300286 | Netherlands | Start Trial | PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424 |
1104436 | 307 | Finland | Start Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |