Neomycin sulfate - Generic Drug Details

What are the generic sources for neomycin sulfate and what is the scope of freedom to operate?

Neomycin sulfate is the generic ingredient in thirteen branded drugs marketed by Pharmacia And Upjohn, X Gen Pharms, Pfizer, Bristol Myers Squibb, Chartwell Molecular, Lannett, Lilly, Nostrum Labs Inc, Roxane, Sandoz, Teva, Xgen Pharms, Glaxosmithkline, Alcon, Watson Labs, Monarch Pharms, Allergan, Merck, Savage Labs, Fougera, and Pharmaderm, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for neomycin sulfate. Four suppliers are listed for this compound.

Summary for neomycin sulfate

US Patents:	0
Tradenames:	13
Applicants:	21
NDAs:	31
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	10
Patent Applications:	6,996
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in neomycin sulfate?	neomycin sulfate excipients list
DailyMed Link:	neomycin sulfate at DailyMed

Recent Clinical Trials for neomycin sulfate

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

Sponsor	Phase
Mahidol University	Phase 4
Joshua Stern	Early Phase 1
Albert Einstein College of Medicine	Early Phase 1

See all neomycin sulfate clinical trials

Pharmacology for neomycin sulfate

Drug Class

Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for neomycin sulfate

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for neomycin sulfate

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

R02AB	Antibiotics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for neomycin sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	NEO-DELTA-CORTEF	neomycin sulfate; prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	061037-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alcon	STATROL	neomycin sulfate; polymyxin b sulfate	OINTMENT;OPHTHALMIC	050344-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Alcon	STATROL	neomycin sulfate; polymyxin b sulfate	SOLUTION/DROPS;OPHTHALMIC	050456-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sandoz	NEOMYCIN SULFATE	neomycin sulfate	TABLET;ORAL	061586-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Xgen Pharms	NEOMYCIN AND POLYMYXIN B SULFATE	neomycin sulfate; polymyxin b sulfate	SOLUTION;IRRIGATION	065106-001	Jan 31, 2006	AT	RX	No	No
Teva	NEOMYCIN SULFATE	neomycin sulfate	TABLET;ORAL	060304-001	Approved Prior to Jan 1, 1982	AA	RX	No	Yes
X Gen Pharms	NEO-FRADIN	neomycin sulfate	SOLUTION;ORAL	065010-001	May 23, 2002		DISCN	No	No