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Last Updated: November 2, 2024

Fosfomycin tromethamine - Generic Drug Details


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What are the generic sources for fosfomycin tromethamine and what is the scope of patent protection?

Fosfomycin tromethamine is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal, Cipla, Xiromed, and Zambon Spa, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for fosfomycin tromethamine. Six suppliers are listed for this compound.

Summary for fosfomycin tromethamine
Drug Prices for fosfomycin tromethamine

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Recent Clinical Trials for fosfomycin tromethamine

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

SponsorPhase
Benova (Tianjin) Innovative medicine Research Co., Ltd.Phase 3
SaltroPhase 3
MJM BontenPhase 3

See all fosfomycin tromethamine clinical trials

Medical Subject Heading (MeSH) Categories for fosfomycin tromethamine

US Patents and Regulatory Information for fosfomycin tromethamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal FOSFOMYCIN TROMETHAMINE fosfomycin tromethamine FOR SOLUTION;ORAL 216600-001 Mar 25, 2024 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla FOSFOMYCIN TROMETHAMINE fosfomycin tromethamine FOR SOLUTION;ORAL 211881-001 Jan 26, 2022 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd FOSFOMYCIN TROMETHAMINE fosfomycin tromethamine FOR SOLUTION;ORAL 214554-001 Oct 21, 2021 AA 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

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