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Serving leading biopharmaceutical companies globally:

Baxter
Cantor Fitzgerald
Express Scripts
Merck
Moodys
Julphar
Accenture
Novartis
QuintilesIMS
Queensland Health

Generated: November 24, 2017

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Clarithromycin - Generic Drug Details

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What are the generic sources for clarithromycin and what is the scope of clarithromycin patent protection?

Clarithromycin
is the generic ingredient in three branded drugs marketed by Ranbaxy, Allied Pharma Inc, Lupin Ltd, Sandoz, Ivax Sub Teva Pharms, Actavis Labs Fl Inc, Idt Australia Ltd, Mayne Pharma, Teva, Abbvie, Wockhardt, Sun Pharm Inds Ltd, West-ward Pharms Int, Apotex Corp, Hec Pharm Usa Inc, Aurobindo, and Mylan, and is included in twenty-three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Clarithromycin has sixty-one patent family members in twenty-nine countries and one supplementary protection certificate in one country.

There are twenty-one drug master file entries for clarithromycin. Forty suppliers are listed for this compound.

Medical Subject Heading (MeSH) Categories for clarithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065178-001May 25, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
CLARITHROMYCIN
clarithromycin
FOR SUSPENSION;ORAL065283-003Sep 4, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065195-001Mar 11, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065137-002May 31, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Hec Pharm Usa Inc
CLARITHROMYCIN
clarithromycin
TABLET;ORAL203584-001Sep 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
CLARITHROMYCIN
clarithromycin
TABLET, EXTENDED RELEASE;ORAL065145-001Jun 24, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Idt Australia Ltd
CLARITHROMYCIN
clarithromycin
TABLET, EXTENDED RELEASE;ORAL065250-001Aug 25, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Hec Pharm Usa Inc
CLARITHROMYCIN
clarithromycin
TABLET;ORAL203584-002Sep 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065155-001May 31, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Allied Pharma Inc
CLARITHROMYCIN
clarithromycin
TABLET;ORAL202710-002Jun 10, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: clarithromycin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL050775-001Mar 3, 2000► Subscribe► Subscribe
Abbvie
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL050775-001Mar 3, 2000► Subscribe► Subscribe
Abbvie
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL050775-001Mar 3, 2000► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: clarithromycin

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
6,872,407 Extended release formulations of erythromycin derivatives► 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: clarithromycin

Country Document Number Estimated Expiration
Israel149033► Subscribe
European Patent Office1223949► Subscribe
Canada2285266► Subscribe
Czech Republic294333► Subscribe
Poland402949► Subscribe
Hong Kong1027023► Subscribe
New Zealand596215► Subscribe
New Zealand537410► Subscribe
Spain2205454► Subscribe
Norway20021747► 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: CLARITHROMYCIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021Belgium► SubscribePRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Merck
McKesson
Cerilliant
Mallinckrodt
AstraZeneca
Dow
Harvard Business School
McKinsey
Accenture

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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