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

Amoxicillin has thirty-seven patent family members in six countries.

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

Summary for amoxicillin

International Patents:	37
US Patents:	15
Tradenames:	23
Applicants:	28
NDAs:	116
Drug Master File Entries:	46
Suppliers / Packagers:	27
Bulk Api Vendors:	63
Clinical Trials:	443
Patent Applications:	7,046
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

See drug prices for amoxicillin

Drug Sales Revenue Trends for amoxicillin

See drug sales revenues for amoxicillin

Recent Clinical Trials for amoxicillin

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

Sponsor	Phase
University of Lausanne	Phase 4
Poitiers University Hospital	Phase 3
Iqvia Pty Ltd	Phase 4

See all amoxicillin clinical trials

Pharmacology for amoxicillin

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

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
Hikma	AMOXICILLIN	amoxicillin	TABLET, CHEWABLE;ORAL	205274-001	Jun 25, 2020	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Aurobindo Pharma Ltd	AMOXICILLIN	amoxicillin	TABLET, FOR SUSPENSION;ORAL	065324-002	Jan 17, 2007		DISCN	No	No	Start Trial	Start Trial				Start Trial
Sandoz	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065066-001	Jun 5, 2002	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Neopharma	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002		DISCN	Yes	No	Start Trial	Start Trial	Y			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

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

International Patents for amoxicillin

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Country	Patent Number	Estimated Expiration
Australia	2006351475	Start Trial
Australia	2003262626	Start Trial
Japan	2005538121	Start Trial
Japan	2010511607	Start Trial
>Country	>Patent Number	>Estimated Expiration

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