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Last Updated: October 14, 2024

Amoxicillin; clavulanate potassium - Generic Drug Details


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What are the generic drug 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, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Us Antibiotics, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-six suppliers are listed for this compound.

Summary for amoxicillin; clavulanate potassium
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
Alphacait, LLCPhase 2

See all amoxicillin; clavulanate potassium clinical trials

Pharmacology for amoxicillin; clavulanate potassium
Paragraph IV (Patent) Challenges for AMOXICILLIN; CLAVULANATE POTASSIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AUGMENTIN XR Extended-release Tablets amoxicillin; clavulanate potassium 1000 mg/62.5 mg 050785 1 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 FOR SUSPENSION;ORAL 065162-001 Mar 12, 2004 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz Inc AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065117-001 Nov 27, 2002 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201090-001 Dec 20, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Us Antibiotics AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET, CHEWABLE;ORAL 050597-002 Jul 22, 1985 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Inds Ltd AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065102-001 Sep 17, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Us Antibiotics AUGMENTIN '500' amoxicillin; clavulanate potassium TABLET;ORAL 050564-002 Aug 6, 1984 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Us Antibiotics AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 ⤷  Sign Up ⤷  Sign Up
Us Antibiotics AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 ⤷  Sign Up ⤷  Sign Up
Us Antibiotics AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 ⤷  Sign Up ⤷  Sign Up
Us Antibiotics AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 ⤷  Sign Up ⤷  Sign Up
Us Antibiotics AUGMENTIN XR amoxicillin; clavulanate potassium TABLET, EXTENDED RELEASE;ORAL 050785-001 Sep 25, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.