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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

AUGMENTIN XR Drug Profile

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Which patents cover Augmentin Xr, and when can generic versions of Augmentin Xr launch?

Augmentin Xr is a drug marketed by Neopharma and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-six patent family members in forty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Augmentin Xr

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for AUGMENTIN XR
Drug Prices for AUGMENTIN XR

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Recent Clinical Trials for AUGMENTIN XR

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SponsorPhase
Chang Gung Memorial HospitalN/A
Singapore General HospitalPhase 4
National Center for Complementary and Integrative Health (NCCIH)Early Phase 1

See all AUGMENTIN XR clinical trials

Paragraph IV (Patent) Challenges for AUGMENTIN XR
Tradename Dosage Ingredient NDA Submissiondate
AUGMENTIN XR TABLET, EXTENDED RELEASE;ORAL amoxicillin; clavulanate potassium 050785 2009-01-21

US Patents and Regulatory Information for AUGMENTIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AUGMENTIN XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002   Start Trial   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002   Start Trial   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002   Start Trial   Start Trial
Neopharma AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Mallinckrodt
Boehringer Ingelheim
Express Scripts
Johnson and Johnson

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