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Last Updated: July 19, 2024

Bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride - Generic Drug Details


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What are the generic drug 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, Riconpharma Llc, and Labs Juvise, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Recent Clinical Trials for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

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

SponsorPhase
American University of Beirut Medical CenterPhase 4
The University of Texas Health Science Center, HoustonPhase 4
Axcan PharmaPhase 3

See all bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride clinical trials

Pharmacology for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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
Riconpharma Llc 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
>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

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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