Amoxicillin - Generic Drug Details

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What are the generic 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, Endo Operations, Hikma, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Takeda Pharms Usa, Cumberland, Phathom, Aurobindo Pharma, Cipla, 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 twelve 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-six suppliers are listed for this compound.

Summary for amoxicillin

International Patents:	11
US Patents:	12
Tradenames:	25
Applicants:	34
NDAs:	126
Drug Master File Entries:	46
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	581
Patent Applications:	6,473
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
Rutgers, The State University of New Jersey	Phase 3
National Institute of Dental and Craniofacial Research (NIDCR)	Phase 3
National Dental PBRN	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

Anatomical Therapeutic Chemical (ATC) Classes for amoxicillin

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Sandoz	AMOXICILLIN	amoxicillin	TABLET;ORAL	065228-002	Jul 13, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065191-002	Jan 25, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET, CHEWABLE;ORAL	065205-001	Feb 9, 2005		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065317-003	Oct 20, 2008		DISCN	No	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

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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	⤷ Sign Up	⤷ Sign Up
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	⤷ Sign Up	⤷ Sign Up
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008	⤷ Sign Up	⤷ Sign Up
>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
European Patent Office	1968586	COMPOSITIONS PHARMACEUTIQUES ET MÉTHODES POUR ÉRADICATION BACTÉRIENNE AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS AND METHODS FOR IMPROVED BACTERIAL ERADICATION)	⤷ Sign Up
China	101563466	Modified release amoxicillin products	⤷ Sign Up
Australia	2006351475	Modified release amoxicillin products	⤷ Sign Up
Japan	2010511607		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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