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Telithromycin - Generic Drug Details

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Telithromycin is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-two patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for Generic Name: telithromycin

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: telithromycin

Ingredient-typeKetolides
Drug ClassKetolide Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-002Feb 9, 2005DISCNNoD459798► subscribeY ► subscribe
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-001Apr 1, 2004DISCNNo5,635,485► subscribeYY ► subscribe
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-002Feb 9, 2005DISCNNo5,635,485► subscribeYY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: telithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-002Feb 9, 2005D459798► subscribe
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-001Apr 1, 2004D459798► subscribe
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Non-Orange Book Patents for Generic Ingredient: telithromycin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,100,404 Erythromycin compounds► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: telithromycin

Country Document Number Estimated Expiration
Spain2122472► subscribe
Hungary9904687► subscribe
African Intellectual Property Organization (OAPI)10319► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TELITHROMYCIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0055France► subscribePRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709
2002001Lithuania► subscribePRODUCT 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
2002001,C0680967Lithuania► subscribePRODUCT 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
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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 verifification 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.

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