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. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for telbivudine.
Summary for TELBIVUDINE
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 82 |
| Clinical Trials: | 83 |
| Patent Applications: | 5,002 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for TELBIVUDINE
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TYZEKA | telbivudine | SOLUTION;ORAL | 022154-001 | Apr 28, 2009 | DISCN | No | 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 TELBIVUDINE
| 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 | TABLET;ORAL | 022011-001 | Oct 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYZEKA | telbivudine | TABLET;ORAL | 022011-001 | Oct 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
