TELITHROMYCIN - Generic Drug Details
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What are the generic drug sources for telithromycin and what is the scope of freedom to operate?
Telithromycin
is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for TELITHROMYCIN
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 32 |
| Clinical Trials: | 28 |
| Patent Applications: | 6,973 |
| What excipients (inactive ingredients) are in TELITHROMYCIN? | TELITHROMYCIN excipients list |
| DailyMed Link: | TELITHROMYCIN at DailyMed |
Recent Clinical Trials for TELITHROMYCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Grossman, S.A. | Phase 3 |
| Instituto Nacional de Salud Publica, Mexico | Phase 3 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for TELITHROMYCIN
US Patents and Regulatory Information for TELITHROMYCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-001 | Apr 1, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-002 | Feb 9, 2005 | 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 TELITHROMYCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-002 | Feb 9, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-001 | Apr 1, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-001 | Apr 1, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-002 | Feb 9, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TELITHROMYCIN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Aventis Pharma S.A. | Ketek | telithromycin | EMEA/H/C/000354 When prescribing Ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance.Ketek is indicated for the treatment of the following infections:In patients of 18 years and oldercommunity-acquired pneumonia, mild or moderate.when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin:acute exacerbation of chronic bronchitis;acute sinusitis;In patients of 12 years and oldertonsillitis / pharyngitis caused by Streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant S. pyogenes, when mediated by ermTR or mefA. |
Withdrawn | no | no | no | 2001-07-09 | |
| Aventis Pharma S.A. | Levviax | telithromycin | EMEA/H/C/000355 When prescribing Levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).Levviax is indicated for the treatment of the following infections:In patients of 18 years and older:-Community-acquired pneumonia, mild or moderate (see section 4.4).- When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):- Acute exacerbation of chronic bronchitis,- Acute sinusitisIn patients of 12 years and older:- Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1). |
Withdrawn | no | no | no | 2001-07-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
