Fosfomycin tromethamine - Generic Drug Details

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, Aurobindo Pharma Ltd, Cipla, Precision Dose Inc, Xiromed, and Zambon Spa, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for fosfomycin tromethamine

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	5
Patent Applications:	1,035
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
MJM Bonten	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	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

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
Cipla	FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	211881-001	Jan 26, 2022	AA	RX	No	No
Xiromed	FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	212548-001	Oct 6, 2020	AA	RX	No	Yes
Precision Dose Inc	FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	217187-001	Jun 3, 2025	AA	RX	No	No
Amneal	FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	216600-001	Mar 25, 2024	AA	RX	No	No

Fosfomycin tromethamine Market Analysis and Financial Projection

Last updated: February 11, 2026

What Is the Current Market Status of FOSFOMYCIN TROMETHAMINE?

Fosfomycin tromethamine is an antibiotic primarily used for urinary tract infections (UTIs). Its market has experienced limited growth historically but shows signs of expansion driven by antimicrobial resistance concerns. The global market size was valued at approximately $300 million in 2022, with projections reaching around $500 million by 2030, growing at a compound annual growth rate (CAGR) of 5.2% (from [1]).

What Are the Key Drivers and Constraints in the Market?

Drivers

• Growing antibiotic resistance: Increasing resistance to conventional antibiotics favors fosfomycin as a resilient alternative, particularly for multidrug-resistant strains of E. coli and Klebsiella pneumoniae.
• Regulatory approvals: Several regions, including the US and EU, have approved or expanded indications for fosfomycin, especially for complicated UTIs.
• Rising prevalence of UTIs: Annually, hundreds of millions of cases worldwide, notably in women and the elderly, create persistent demand.

Constraints

• Limited awareness: Among clinicians, fosfomycin remains underprescribed relative to more established antibiotics.
• Generic competition: Several generic formulations reduce pricing pressures but limit profit margins.
• Supply chain variability: As an older drug, supply chain reliability varies across regions, influenced by manufacturing priorities.

How Does Product Development and Regulatory Landscape Influence Market Trajectory?

• Ongoing clinical trials: Strategies focus on expanding indications, such as bone infections and bloodstream infections, which could broaden market scope.
• Regulatory trends: The US FDA granted fosfomycin a qualified infectious disease product (QIDP) designation, potentially accelerating approval processes for new formulations or expanded indications.
• Pipeline activity: Several pharmaceutical companies, including specialist antimicrobials firms, are developing IV formulations and combination therapies, aiming to penetrate hospital-based markets.

What Are the Financial Trends and Investment Opportunities?

Revenue and Profitability

• Leading marketed brands, such as Monurol (sodium fosfomycin), generate the majority of revenues in developed markets.
• Sales are characterized by moderate growth, with revenue primarily driven by patent expirations and generic uptake.

Cost Dynamics

• Development costs for new formulations or expanded indications vary but generally range between $50 million and $150 million, including clinical trials, regulatory submissions, and commercialization expenses.
• The local manufacturing costs for fosfomycin are low compared to newer drugs, aiding margin preservation.

Investment Risks

• Resistance evolution may limit long-term efficacy.
• Regulatory hurdles could slow approval timelines.
• Market penetration remains challenging due to established competition and clinician preferences.

How Do Competitive and Market Entry Strategies Shape the Future?

• Firms pursuing niche indications, such as multidrug-resistant bacteria, have a competitive advantage.
• Partnerships with healthcare providers and investment in awareness campaigns can drive adoption.
• Geographic expansion into emerging markets presents growth opportunities; however, local regulatory environments vary significantly.

What Is the Outlook for the Next Decade?

The pharmaceutical market for fosfomycin tromethamine is expected to grow steadily due to its role against resistant bacteria. Its future depends on successful clinical trial outcomes, regulatory approvals for new indications or formulations, and strategic positioning against emerging competitors.

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Key Takeaways

• The global fosfomycin tromethamine market is projected to grow at 5.2% CAGR, reaching approximately $500 million by 2030.
• Market growth is mainly driven by antimicrobial resistance and expanding regulatory approvals.
• Generic competition and clinician awareness are primary barriers.
• Investment in new formulations and indications could enhance long-term value.
• Resistance development remains a significant risk to sustained efficacy and market stability.

FAQs

1. What are the primary indications for fosfomycin tromethamine?
Urinary tract infections, particularly uncomplicated and complicated UTIs, showcase the main approved uses. Research is ongoing to expand into systemic infections.

2. Which regions represent key markets?
North America and Europe dominate due to established healthcare infrastructure and regulatory approvals. Asia-Pacific is emerging as a growth region owing to rising antimicrobial resistance and healthcare expansion.

3. How do patent expirations impact the market?
Patent expiry leads to increased generic entries, reducing prices and revenues for branded versions. This transition pressures profit margins but expands access.

4. What are the clinical challenges associated with fosfomycin?
Limited clinical data for systemic infections and resistance development pose challenges for wider adoption.

5. How can companies maximize market share?
By developing new formulations, securing regulatory approvals for broader indications, and engaging clinicians through education and collaboration.

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Sources
[1] MarketsandMarkets. "Fosfomycin Market by Dosage Form, Application, and Region," 2022.