TYZEKA Drug Patent Profile
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When do Tyzeka patents expire, and what generic alternatives are available?
Tyzeka is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in TYZEKA is telbivudine. There are two drug master file entries for this compound. Additional details are available on the telbivudine profile page.
Summary for TYZEKA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 5 |
Patent Applications: | 3,149 |
Formulation / Manufacturing: | see details |
DailyMed Link: | TYZEKA at DailyMed |
Recent Clinical Trials for TYZEKA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chinese University of Hong Kong | N/A |
Novartis Pharmaceuticals | Phase 3 |
Novartis | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for TYZEKA
US Patents and Regulatory Information for TYZEKA
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 | ⤷ Try a Trial | ||||
Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 TYZEKA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 |
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 | 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 TYZEKA
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 TYZEKA
See the table below for patents covering TYZEKA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2531928 | ⤷ Try a Trial | |
China | 101120947 | ⤷ Try a Trial | |
Brazil | 9912896 | ⤷ Try a Trial | |
Denmark | 2415776 | ⤷ Try a Trial | |
Japan | 2002522552 | ⤷ Try a Trial | |
South Korea | 100892177 | ⤷ Try a Trial | |
Cyprus | 1117836 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYZEKA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1104436 | 39/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: TELBIVUDIN; REGISTRATION NO/DATE: EU/1/07/388/001 20070424 |
1104436 | 300286 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE |
1104436 | CA 2007 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TELBIVUDINE |
1104436 | SZ 39/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: TELBIVUDIN |
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 |
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 | FR07C0046 | France | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |