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Serving leading biopharmaceutical companies globally:

Accenture
Express Scripts
McKinsey
Fish and Richardson
Covington
Chubb
US Army
Johnson and Johnson
Merck
Mallinckrodt

Generated: October 20, 2017

DrugPatentWatch Database Preview

BIAXIN XL Drug Profile

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What is the patent landscape for Biaxin Xl, and when can generic versions of Biaxin Xl launch?

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 fifty-nine 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-one suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for Tradename: BIAXIN XL

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list35
Clinical Trials: see list30
Patent Applications: see list6,616
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BIAXIN XL at DailyMed

Pharmacology for Tradename: BIAXIN XL

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
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: 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:

AstraZeneca
Dow
Express Scripts
QuintilesIMS
Baxter
Johnson and Johnson
Chubb
Cantor Fitzgerald
Chinese Patent Office
Daiichi Sankyo

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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