KETEK Drug Patent Profile
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Which patents cover Ketek, and when can generic versions of Ketek launch?
Ketek is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in KETEK is telithromycin. Additional details are available on the telithromycin profile page.
Summary for KETEK
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Patent Applications: | 7,023 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in KETEK? | KETEK excipients list |
| DailyMed Link: | KETEK at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for KETEK
US Patents and Regulatory Information for KETEK
| 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 | 021144-002 | Feb 9, 2005 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sanofi Aventis Us | KETEK | telithromycin | TABLET;ORAL | 021144-001 | Apr 1, 2004 | 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 KETEK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 021144-001 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for KETEK
| 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 |
International Patents for KETEK
See the table below for patents covering KETEK around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Moldova, Republic of | 1233 | Derivati de eritromicina, procedeu de preparare a lor si compozitie farmaceu-tica pe baza acestora (Erythromycin derivatives, process for their preparation and pharmaceutical composition on base thereof) | ⤷ Try a Trial |
| Hong Kong | 1010732 | ⤷ Try a Trial | |
| Spain | 2122472 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KETEK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0680967 | PA2002001 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TELITHROMYCINUM (11,12-DIDEOKSI 3-DE((2,6-DIDEOKSI-3-C-METIL-3-O-METIL-ALFA-L-RIBOHEKSOPIRANOZIL)OKSI) 6-O-METIL 3-OKSO 12,11-(OKSIKARBONIL ((4-(4-(3-PIRIDINIL) 1H-IMIDAZOL-1-IL)BUTIL)IMINO))ERITROMICINAS); REGISTRATION NO/DATE: 01/7551/9 20011107 |
| 0680967 | SPC030/2001 | Ireland | ⤷ Try a Trial | SPC030/2001: 20031204, EXPIRES: 20160708 |
| 0680967 | CA 2002 00001 | Denmark | ⤷ Try a Trial | DKCTFF , , EXPIRES: |
| >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.
ISSN: 2162-2639
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