AMPICILLIN SODIUM; SULBACTAM SODIUM - Generic Drug Details

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What are the generic drug sources for ampicillin sodium; sulbactam sodium and what is the scope of patent protection?

Ampicillin sodium; sulbactam sodium is the generic ingredient in two branded drugs marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Medimetriks Pharms, Sandoz, Steriscience Speclts, and Pfizer, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Sponsor	Phase
DongGuk University
Pfizer	Phase 3

Sponsor

Phase

DongGuk University

Pfizer

Phase 3

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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
Eugia Pharma Speclts	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090349-001	Sep 20, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608-003	Dec 31, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608-005	Dec 10, 1993	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090340-001	Sep 20, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astral	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090579-001	Jan 8, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astral	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090578-001	Jan 11, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acs Dobfar	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	065406-002	Dec 22, 2009	AP	RX	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

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	25
Finished Product Suppliers / Packagers:	12
Clinical Trials:	2
DailyMed Link:	AMPICILLIN SODIUM; SULBACTAM SODIUM at DailyMed

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