BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride and what is the scope of patent protection?

Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Endo Operations, Novast Labs, and Labs Juvise, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Clinical Trials:	3
DailyMed Link:	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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

Sponsor	Phase
American University of Beirut Medical Center	Phase 4
The University of Texas Health Science Center, Houston	Phase 4
Axcan Pharma	Phase 3

See all BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE clinical trials

Pharmacology for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Drug Class	Bismuth Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for BISMUTH SUBCITRATE POTASSIUM; 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

A02BX	Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
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

Paragraph IV (Patent) Challenges for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PYLERA	Capsules	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	140 mg/125 mg/ 125 mg	050786	1	2014-08-12

US Patents and Regulatory Information for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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Glossary

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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
Novast Labs	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	217511-001	Jul 3, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	205770-001	Mar 6, 2023	AB	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

Expired US Patents for BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	⤷ Sign Up	⤷ Sign Up
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	⤷ Sign Up	⤷ Sign Up
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786-001	Sep 28, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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