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Serving 500+ biopharmaceutical companies globally:

Deloitte
Johnson and Johnson
Mallinckrodt
Colorcon
Chubb
Harvard Business School
Farmers Insurance
Baxter
McKesson
Moodys

Generated: August 17, 2017

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Telithromycin - Generic Drug Details

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What are the generic sources for telithromycin and what is the scope of telithromycin freedom to operate?

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

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

One supplier is listed for this compound.

Summary for Generic Name: telithromycin

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list41
Clinical Trials: see list27
Patent Applications: see list3,328
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:telithromycin at DailyMed

Pharmacology for Ingredient: telithromycin

Ingredient-typeKetolides
Drug ClassKetolide Antibacterial
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;ORAL021144-002Feb 9, 2005DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-001Apr 1, 2004DISCNNoNo► Subscribe► 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, 2005► Subscribe► Subscribe
Sanofi Aventis Us
KETEK
telithromycin
TABLET;ORAL021144-001Apr 1, 2004► Subscribe► 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
Finland111263► Subscribe
Czech Republic9603214► Subscribe
Hong Kong1010732► Subscribe
France2719587► Subscribe
Israel113245► 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
2002 00001Denmark► SubscribeDKCTFF , , EXPIRES:
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
C030/2001Ireland► SubscribeSPC030/2001: 20031204, EXPIRES: 20160708
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Argus Health
Deloitte
Baxter
Fish and Richardson
Colorcon
Farmers Insurance
Federal Trade Commission
McKesson
Chubb

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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