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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Farmers Insurance
Fish and Richardson
Citi
Federal Trade Commission
McKinsey
Baxter
US Department of Justice
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Generated: October 20, 2017

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CLARITHROMYCIN - Generic Drug Details

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What are the generic drug 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 fifty-nine 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-two suppliers are listed for this compound.

Summary for Generic Name: CLARITHROMYCIN

US Patents:2
Tradenames:3
Applicants:17
NDAs:23
Drug Master File Entries: see list21
Suppliers / Packagers: see list42
Bulk Api Vendors: see list34
Clinical Trials: see list246
Patent Applications: see list6,255
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:CLARITHROMYCIN at DailyMed

Pharmacology for Ingredient: CLARITHROMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
BIAXIN
clarithromycin
TABLET;ORAL050662-001Oct 31, 1991ABRXYesYes► Subscribe► Subscribe► Subscribe
Mayne Pharma
CLARITHROMYCIN
clarithromycin
TABLET, EXTENDED RELEASE;ORAL065154-001May 18, 2005ABRXNoYes► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065137-002May 31, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl Inc
CLARITHROMYCIN
clarithromycin
TABLET, EXTENDED RELEASE;ORAL065145-001Jun 24, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Abbvie
BIAXIN
clarithromycin
FOR SUSPENSION;ORAL050698-001Dec 23, 1993ABRXYesNo► Subscribe► Subscribe► Subscribe
Ranbaxy
CLARITHROMYCIN
clarithromycin
TABLET, EXTENDED RELEASE;ORAL065210-001Jan 26, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
CLARITHROMYCIN
clarithromycin
TABLET, EXTENDED RELEASE;ORAL202532-001Sep 15, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065144-001Oct 18, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Wockhardt
CLARITHROMYCIN
clarithromycin
TABLET;ORAL065266-002May 31, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Hec Pharm Usa Inc
CLARITHROMYCIN
clarithromycin
TABLET;ORAL203584-001Sep 28, 2015ABRXNoNo► 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
Poland354783► Subscribe
Canada2285266► Subscribe
Bulgaria103862► Subscribe
Brazil0010485► Subscribe
Portugal973527► Subscribe
Hungary0203540► Subscribe
New Zealand337120► Subscribe
Argentina012358► Subscribe
Australia1203601► Subscribe
World Intellectual Property Organization (WIPO)9846239► 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:

Dow
Healthtrust
McKinsey
Queensland Health
QuintilesIMS
Deloitte
Fuji
Farmers Insurance
Johnson and Johnson
Mallinckrodt

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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