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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Fuji
UBS
Covington
Express Scripts
Moodys
Colorcon
Novartis
McKesson
Federal Trade Commission

Generated: November 23, 2017

DrugPatentWatch Database Preview

BIAXIN XL Drug Profile

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What is the patent landscape for Biaxin Xl, and what generic Biaxin Xl alternatives are available?

Biaxin Xl is a drug marketed by Abbvie and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in BIAXIN XL is clarithromycin. There are twenty-one drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL050775-001Mar 3, 2000DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Abbvie
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL050775-001Mar 3, 2000DISCNYesNo► Subscribe► Subscribe ► Subscribe
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Expired Patents for Tradename: BIAXIN XL

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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Paragraph IV (Patent) Challenges for BIAXIN XL

Drugname Dosage Strength RLD Submissiondate
clarithromycinExtended-release Tablet500 mgBiaxin XL12/6/2010

Non-Orange Book Patents for Tradename: BIAXIN XL

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 Tradename: BIAXIN XL

Country Document Number Estimated Expiration
New Zealand537410► Subscribe
Canada2465698► Subscribe
Denmark0973527► Subscribe
Taiwan576743► Subscribe
Canada2387621► Subscribe
Hungary0001382► Subscribe
Hungary0203540► Subscribe
Argentina026045► Subscribe
South Korea100484559► Subscribe
South Korea20010006251► 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: BIAXIN XL

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:

Queensland Health
Fuji
Fish and Richardson
Argus Health
Federal Trade Commission
Cipla
Express Scripts
US Army
Harvard Business School
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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