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Last Updated: December 6, 2021

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Bismuth subsalicylate; metronidazole; tetracycline hydrochloride - Generic Drug Details

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What are the generic drug 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 Ailex Pharms Llc and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for bismuth subsalicylate; metronidazole; tetracycline hydrochloride. One supplier is listed for this compound.

Summary for bismuth subsalicylate; metronidazole; tetracycline hydrochloride
Recent Clinical Trials for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

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

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
M.D. Anderson Cancer CenterPhase 2

See all bismuth subsalicylate; metronidazole; tetracycline hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ailex Pharms Llc BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 202584-001 Nov 30, 2018 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.