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.
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Summary for TYZEKA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,789 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 TYZEKA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >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 | ⤷ Sign Up | |
| Australia | 5475799 | ⤷ Sign Up | |
| Cyprus | 1116988 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYZEKA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1104436 | 91348 | Luxembourg | ⤷ Sign Up | CERTIFICATE NAME: TELVIDUBINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; FIRST REGISTRATION DATE: 20070424 |
| 1104436 | 2007/027 | Ireland | ⤷ Sign Up | PRODUCT NAME: TELBIVUDINE AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/07/388/001 20070424 |
| 1104436 | C300286 | Netherlands | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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