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Last Updated: November 29, 2022

Amoxicillin - Generic Drug Details


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What are the generic sources for amoxicillin and what is the scope of patent protection?

Amoxicillin is the generic ingredient in twenty-five branded drugs marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Us Antibiotics, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Belcher Pharms, Dava Pharms Inc, Hikma, Wockhardt Bio Ag, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Sandoz Inc, Takeda Pharms Usa, Cumberland Pharms, Phathom, Aurobindo Pharma, Micro Labs Ltd India, Apotex Inc, Teva Pharms Usa, and Redhill, and is included in one hundred and twenty NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has eleven patent family members in six countries.

There are forty-six drug master file entries for amoxicillin. Thirty suppliers are listed for this compound.

Drug Prices for amoxicillin

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Drug Sales Revenue Trends for amoxicillin

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Recent Clinical Trials for amoxicillin

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

SponsorPhase
Kaizen Bioscience Co.Phase 1
Liaocheng People's HospitalPhase 1
The Taimaka ProjectPhase 3

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Pharmacology for amoxicillin
Medical Subject Heading (MeSH) Categories for amoxicillin

US Patents and Regulatory Information for amoxicillin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd AMOXICILLIN amoxicillin TABLET, FOR SUSPENSION;ORAL 065324-002 Jan 17, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva AMOXICILLIN amoxicillin TABLET, CHEWABLE;ORAL 064031-001 Dec 19, 1996 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN amoxicillin; clarithromycin; omeprazole CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL 050824-001 Feb 8, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 See Plans and Pricing See Plans and Pricing
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 See Plans and Pricing See Plans and Pricing
Pragma MOXATAG amoxicillin TABLET, EXTENDED RELEASE;ORAL 050813-001 Jan 23, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for amoxicillin

Country Patent Number Title Estimated Expiration
Australia 2006321782 Pharmaceutical compositions and methods for improved bacterial eradication See Plans and Pricing
European Patent Office 1968586 COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES POUR ÉRADICATION BACTÉRIENNE AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION) See Plans and Pricing
European Patent Office 1969134 PRODUITS D'AMOXICILLINE À LIBÉRATION MODIFIÉE (MODIFIED RELEASE AMOXICILLIN PRODUCTS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Harvard Business School
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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.