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Last Updated: March 19, 2024

Telithromycin - Generic Drug Details


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What are the generic 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
Formulation / Manufacturing:see details
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

SponsorPhase
Instituto Nacional de Salud Publica, MexicoPhase 3
Laboratorios Grossman, S.A.Phase 3
Federal University of São PauloPhase 4

See all telithromycin clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us KETEK telithromycin TABLET;ORAL 021144-002 Feb 9, 2005 DISCN No 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 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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us KETEK telithromycin TABLET;ORAL 021144-001 Apr 1, 2004 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us KETEK telithromycin TABLET;ORAL 021144-002 Feb 9, 2005 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us KETEK telithromycin TABLET;ORAL 021144-001 Apr 1, 2004 ⤷  Try a Trial ⤷  Try a Trial
>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

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