Ampicillin sodium - Generic Drug Details

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

Ampicillin sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Consolidated Pharm, Eugia Pharma Speclts, Hikma, Hospira, Hq Speclt Pharma, Intl Medication, Istituto Bio Ita Spa, Lilly, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Watson Labs Inc, Wyeth Ayerst, Bristol, Glaxosmithkline, Acs Dobfar, Astral, Hospira Inc, Pharm Assoc, and Pfizer, and is included in fifty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for ampicillin sodium. Fifteen suppliers are listed for this compound.

Summary for ampicillin sodium

US Patents:	0
Tradenames:	7
Applicants:	23
NDAs:	56
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	11
Patent Applications:	3,791
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ampicillin sodium?	ampicillin sodium excipients list
DailyMed Link:	ampicillin sodium at DailyMed

Recent Clinical Trials for ampicillin sodium

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all ampicillin sodium clinical trials

Pharmacology for ampicillin sodium

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for ampicillin sodium

Anti-Bacterial Agents

US Patents and Regulatory Information for ampicillin sodium

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
Sandoz	AMPICILLIN SODIUM	ampicillin sodium	POWDER;INTRAVENOUS	062738-001	Feb 19, 1987	AP	RX	No	Yes
Mylan Labs Ltd	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	202197-001	Apr 7, 2014	AP	RX	No	No
Glaxosmithkline	TOTACILLIN-N	ampicillin sodium	INJECTABLE;INJECTION	060677-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol	POLYCILLIN-N	ampicillin sodium	INJECTABLE;INJECTION	050309-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Astral	AMPICILLIN AND SULBACTAM	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	090579-002	Jan 8, 2016	AP	RX	No	No
Wyeth Ayerst	OMNIPEN-N	ampicillin sodium	INJECTABLE;INJECTION	060626-001	Approved Prior to Jan 1, 1982		DISCN	No	No