KETEK Drug Patent Profile

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:	5,413
What excipients (inactive ingredients) are in KETEK?	KETEK excipients list
DailyMed Link:	KETEK at DailyMed

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
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004		DISCN	No	No

Expired US Patents for KETEK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005

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	Withdrawn	no	no	no	2001-07-09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

International Patents for KETEK

See the table below for patents covering KETEK around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4658902
Japan	3998828
Norway	308853
Canada	2189271	NOUVEAUX DERIVES DE L'ERYTHROMYCINE, LEUR PROCEDE DE PREPARATION ET LEUR APPLICATION COMME MEDICAMENTS (NOVEL ERYTHROMYCIN DERIVATIVES, METHOD FOR THEIR PREPARATIONAND THEIR USE AS DRUGS)
Latvia	11739	NOVEL ERYTHROMYCIN DERIVATIVES, METHOD FOR THEIR PREPARATION AND THEIR USE AS DRUGS
Tajikistan	313	Erythromycin's dervatives and pharmaceutical composition on their basis

Supplementary Protection Certificates for KETEK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0680967	01C0055	France		PRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709
0680967	PA2002001	Lithuania		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	PA2002001,C0680967	Lithuania		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		SPC030/2001: 20031204, EXPIRES: 20160708
0680967	CA 2002 00001	Denmark		DKCTFF , , EXPIRES:
0680967	SPC/GB02/001	United Kingdom		PRODUCT NAME: TELITHROMYCIN AND ADDITION SALTS THEREOF WITH PHARMACEUTICALLY ACCEPTABLE ACIDS; REGISTERED: UK EU/1/01/191/001-004 20010710