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

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	5
Patent Applications:	869
Drug Prices:	Drug price trends for fosfomycin tromethamine
What excipients (inactive ingredients) are in fosfomycin tromethamine?	fosfomycin tromethamine excipients list
DailyMed Link:	fosfomycin tromethamine at DailyMed

See drug prices for fosfomycin tromethamine

Recent Clinical Trials for fosfomycin tromethamine

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

Sponsor	Phase
Benova (Tianjin) Innovative medicine Research Co., Ltd.	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Saltro	Phase 3

See all fosfomycin tromethamine clinical trials

Medical Subject Heading (MeSH) Categories for fosfomycin tromethamine

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for fosfomycin tromethamine

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for fosfomycin tromethamine

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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
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
Zambon Spa	MONUROL	fosfomycin tromethamine	FOR SOLUTION;ORAL	050717-001	Dec 19, 1996	AA	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	212548-001	Oct 6, 2020	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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