BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bismuth subsalicylate; metronidazole; tetracycline hydrochloride and what is the scope of freedom to operate?

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Nostrum Labs Inc and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Clinical Trials:	2
DailyMed Link:	BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
National Cancer Institute (NCI)	Phase 2

See all BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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

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

D06AA	Tetracycline and derivatives
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

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 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	HELIDAC	bismuth subsalicylate; metronidazole; tetracycline hydrochloride	TABLET, CHEWABLE, TABLET, CAPSULE;ORAL	050719-001	Aug 15, 1996		DISCN	Yes	No
Nostrum Labs Inc	BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subsalicylate; metronidazole; tetracycline hydrochloride	TABLET, CHEWABLE, TABLET, CAPSULE;ORAL	202584-001	Nov 30, 2018		RX	No	Yes