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
Sandoz	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	065310-002	Jul 25, 2006	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090339-001	Sep 20, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hq Speclt Pharma	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	065176-002	Nov 30, 2005	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608-002	Dec 31, 1986	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090349-002	Sep 20, 2010	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