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Last Updated: October 24, 2021

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BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

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

See all BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE clinical trials

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
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
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
>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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Baxter
Dow
Boehringer Ingelheim
Mallinckrodt

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