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Last Updated: April 23, 2024

AMOXICILLIN - Generic Drug Details

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

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, Chartwell Rx, Dava Pharms Inc, Hikma, Wockhardt Bio Ag, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Takeda Pharms Usa, Cumberland, Phathom, Aurobindo Pharma, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, Teva Pharms Usa, and Redhill, and is included in one hundred and twenty-six NDAs. There are eleven 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-five suppliers are listed for this compound.

Summary for AMOXICILLIN

International Patents:	11
US Patents:	11
Tradenames:	25
Applicants:	34
NDAs:	126
Drug Master File Entries:	46
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	561
Patent Applications:	5,531
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for AMOXICILLIN
Drug Sales Revenues:	Drug sales revenues for AMOXICILLIN
What excipients (inactive ingredients) are in AMOXICILLIN?	AMOXICILLIN excipients list
DailyMed Link:	AMOXICILLIN at DailyMed

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Drug Sales Revenue Trends for AMOXICILLIN

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Recent Clinical Trials for AMOXICILLIN

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Sponsor	Phase
University of Missouri-Columbia	Phase 4
Abdul El-Rabbany	Phase 4
TenNor Therapeutics (Suzhou) Limited	Phase 3

See all AMOXICILLIN clinical trials

Pharmacology for AMOXICILLIN

Drug Class	Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for AMOXICILLIN

Anti-Bacterial Agents

US Patents and Regulatory Information for AMOXICILLIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Us Antibiotics	AMOXIL	amoxicillin	TABLET;ORAL	050754-002	Jul 10, 1998		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Us Antibiotics	AUGMENTIN '250'	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050575-002	Aug 6, 1984	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Us Antibiotics	AMOXIL	amoxicillin	TABLET, CHEWABLE;ORAL	050761-002	Apr 15, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	amoxicillin; clarithromycin; lansoprazole	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	202588-001	Mar 4, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cumberland	OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN	amoxicillin; clarithromycin; omeprazole	CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL	050824-001	Feb 8, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	AMOXICILLIN	amoxicillin	TABLET;ORAL	065228-002	Jul 13, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	⤷ Try a Trial	⤷ Try a Trial
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	⤷ Try a Trial	⤷ Try a Trial
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for AMOXICILLIN

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Country	Patent Number	Title	Estimated Expiration
Japan	5788142		⤷ Try a Trial
China	101563466	Modified release amoxicillin products	⤷ Try a Trial
Japan	2010511607		⤷ Try a Trial
European Patent Office	1968586	COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES POUR ÉRADICATION BACTÉRIENNE AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)	⤷ Try a Trial
European Patent Office	1969134	PRODUITS D'AMOXICILLINE À LIBÉRATION MODIFIÉE (MODIFIED RELEASE AMOXICILLIN PRODUCTS)	⤷ Try a Trial
Australia	2006321782	Pharmaceutical compositions and methods for improved bacterial eradication	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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