Telbivudine - Generic Drug Details
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What are the generic sources for telbivudine and what is the scope of freedom to operate?
Telbivudine
is the generic ingredient in one branded drug marketed by Novartis and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Telbivudine has eleven patent family members in seven countries.
There are two drug master file entries for telbivudine.
Summary for telbivudine
| International Patents: | 11 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 83 |
| Patent Applications: | 5,002 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | telbivudine at DailyMed |
Recent Clinical Trials for telbivudine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mahidol University | Phase 4 |
| Lai Wei | Phase 2 |
| Beijing Ditan Hospital | 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 | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 telbivudine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for telbivudine
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Novartis Europharm Limited | Sebivo | telbivudine | EMEA/H/C/000713 Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate. |
Withdrawn | no | no | no | 2007-04-24 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for telbivudine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 100892177 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2004012687 | ⤷ Try a Trial | |
| European Patent Office | 2607370 | Procédé pour identifier une forme amorphe de beta-L-2'-déoxythymidine (Method for identifying an amorphous form of beta-L-2'-deoxythymidine) | ⤷ Try a Trial |
| Australia | 2003265396 | CRYSTALLINE AND AMORPHOUS FORMS OF BETA-L-2'-DEOXYTHYMIDINE | ⤷ Try a Trial |
| Spain | 2610756 | ⤷ Try a Trial | |
| European Patent Office | 1534727 | COMPOSITIONS PHARMACEUTIQUES DE BETA-L-2'-DEOXYTHYMIDINE CRISTALLINE (PHARMACEUTICAL COMPOSITIONS OF CRYSTALLINE BETA-L-2'-DEOXYTHYMIDINE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for telbivudine
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1104436 | CA 2007 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TELBIVUDINE |
| 1104436 | 2007/027 | Ireland | ⤷ Try a Trial | PRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424 |
| 1104436 | SPC/GB07/058 | United Kingdom | ⤷ Try a Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/058 GRANTED TO NOVARTIS AG, CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE AND L UNIVERSITE MONTPELLIER II IN RESPECT OF THE PRODUCT TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6311 DATED 05 MAY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 25 APRIL 2022. |
| 1104436 | 07C0046 | France | ⤷ Try a 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 | C300286 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TELBIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/07/388/001 20070424 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
