AMOXICILLIN; CLAVULANATE POTASSIUM - Generic Drug Details

What are the generic 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-nine suppliers are listed for this compound.

Summary for AMOXICILLIN; CLAVULANATE POTASSIUM

US Patents:	0
Tradenames:	9
Applicants:	15
NDAs:	49
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	18
Patent Applications:	1,492
DailyMed Link:	AMOXICILLIN; CLAVULANATE POTASSIUM at DailyMed

Recent Clinical Trials for AMOXICILLIN; CLAVULANATE POTASSIUM

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

Sponsor	Phase
Second Affiliated Hospital of Wenzhou Medical University	N/A
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all AMOXICILLIN; CLAVULANATE POTASSIUM clinical trials

Pharmacology for AMOXICILLIN; CLAVULANATE POTASSIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN; CLAVULANATE POTASSIUM

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

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
Deva Holding As	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	209351-001	Sep 13, 2023	AB	RX	No	No
Sandoz	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	090227-001	Apr 21, 2010		RX	No	Yes
Us Antibiotics	AUGMENTIN '400'	amoxicillin; clavulanate potassium	TABLET, CHEWABLE;ORAL	050726-002	May 31, 1996		DISCN	Yes	No
Micro Labs Ltd India	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	205707-001	Dec 30, 2016	AB	RX	No	No
Deva Holding As	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	210416-001	Dec 11, 2023	AB	RX	No	No
Aurobindo Pharma Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	091569-001	Jan 20, 2012	AB	RX	No	No

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
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002