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Pharmaceutical Business Intelligence

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AUGMENTIN XR Drug Profile

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Augmentin Xr is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-two patent family members in forty-seven countries.

The generic ingredient in AUGMENTIN XR is amoxicillin; clavulanate potassium. There are forty-three drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for Tradename: AUGMENTIN XR

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: AUGMENTIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Inc
AUGMENTIN XR
amoxicillin; clavulanate potassium
TABLET, EXTENDED RELEASE;ORAL050785-001Sep 25, 2002RXYes6,878,386► subscribe ► subscribe
Dr Reddys Labs Inc
AUGMENTIN XR
amoxicillin; clavulanate potassium
TABLET, EXTENDED RELEASE;ORAL050785-001Sep 25, 2002RXYes6,783,773► subscribeY ► subscribe
Dr Reddys Labs Inc
AUGMENTIN XR
amoxicillin; clavulanate potassium
TABLET, EXTENDED RELEASE;ORAL050785-001Sep 25, 2002RXYes7,217,430► subscribeY ► subscribe
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Paragraph IV activity for: AUGMENTIN XR

Drugname Dosage Strength RLD Submissiondate
amoxicillin and clavulanate potassiumExtended-release Tablets1000 mg/62.5 mgAugmentin XR1/21/2009

Non-Orange Book Patents for Tradename: AUGMENTIN XR

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
6,294,199 Method of treating a bacterial infection comprising administering amoxycillin► subscribe
6,660,299 Modified release pharmaceutical formulation comprising amoxycillin► 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: AUGMENTIN XR

Country Document Number Estimated Expiration
China100382782► subscribe
World Intellectual Property Organization (WIPO)0061115► subscribe
New Zealand514574► 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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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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