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Last Updated: August 9, 2020

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AMOXICILLIN; CLAVULANATE POTASSIUM - Generic Drug Details

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What are the generic sources for amoxicillin; clavulanate potassium and what is the scope of freedom to operate?

Amoxicillin; clavulanate potassium is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt Bio Ag, Neopharma, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in forty-two NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amoxicillin; clavulanate potassium has ninety-six patent family members in forty-eight countries.

There are forty-six drug master file entries for amoxicillin; clavulanate potassium. Twenty-seven suppliers are listed for this compound.

Summary for AMOXICILLIN; CLAVULANATE POTASSIUM
International Patents:96
US Patents:5
Tradenames:9
Applicants:11
NDAs:42
Drug Master File Entries: 46
Suppliers / Packagers: 27
Bulk Api Vendors: 4
Clinical Trials: 18
Patent Applications: 333
DailyMed Link:AMOXICILLIN; CLAVULANATE POTASSIUM at DailyMed
Recent Clinical Trials for AMOXICILLIN; CLAVULANATE POTASSIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Second Affiliated Hospital of Wenzhou Medical UniversityN/A
Haining Health-Coming Biotech Co., Ltd.Phase 2
University of PittsburghPhase 3

See all AMOXICILLIN; CLAVULANATE POTASSIUM clinical trials

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

US Patents and Regulatory Information for AMOXICILLIN; CLAVULANATE POTASSIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET, CHEWABLE;ORAL 065205-001 Feb 9, 2005 RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201090-001 Dec 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201090-002 Dec 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Bio Ag AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065420-001 Dec 2, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET, CHEWABLE;ORAL 065065-001 Apr 18, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065064-001 Mar 15, 2002 AB RX No No   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 AMOXICILLIN; CLAVULANATE POTASSIUM

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
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:

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