Alatrofloxacin mesylate - Generic Drug Details

What are the generic sources for alatrofloxacin mesylate and what is the scope of freedom to operate?

Alatrofloxacin mesylate is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for alatrofloxacin mesylate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	29
DailyMed Link:	alatrofloxacin mesylate at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for alatrofloxacin mesylate

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for alatrofloxacin mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997		DISCN	No	No
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997		DISCN	No	No

Expired US Patents for alatrofloxacin mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-001	Dec 18, 1997
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997
Pfizer	TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	INJECTABLE;INJECTION	020760-002	Dec 18, 1997

Alatrofloxacin Mesylate: Market Dynamics and Financial Trajectory

Last updated: February 18, 2026

Alatrofloxacin mesylate, a broad-spectrum fluoroquinolone antibiotic, faces a complex market landscape driven by evolving resistance patterns, regulatory scrutiny, and the development of novel therapeutics. Its financial trajectory is directly linked to its perceived efficacy against key pathogens, its positioning relative to emerging alternatives, and its ability to maintain market access amidst pricing pressures.

What is the Current Market Positioning of Alatrofloxacin Mesylate?

Alatrofloxacin mesylate is an intravenous fluoroquinolone antibiotic. It is a prodrug of alatrofloxacin, which is converted to the active form, levofloxacin, in the body [1]. This mechanism of action targets bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication, transcription, repair, and recombination [2].

The drug has historically been indicated for the treatment of serious bacterial infections, including community-acquired pneumonia, nosocomial pneumonia, acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and complicated urinary tract infections [3]. Its broad spectrum of activity includes Gram-positive and Gram-negative bacteria, as well as atypical pathogens.

However, the market positioning of alatrofloxacin mesylate has been influenced by several factors:

• Bacterial Resistance: Increasing rates of fluoroquinolone resistance among common bacterial pathogens such as Streptococcus pneumoniae and Staphylococcus aureus have diminished its utility in certain clinical scenarios [4]. This necessitates careful susceptibility testing before prescribing.
• Availability of Oral Levofloxacin: As alatrofloxacin mesylate is a prodrug for levofloxacin, the availability of oral levofloxacin offers a more convenient and cost-effective treatment option for transitioning patients from intravenous therapy or for outpatient management of susceptible infections [5]. This often leads to a step-down approach, where intravenous alatrofloxacin mesylate is used for initial severe infections, followed by oral levofloxacin.
• Emergence of New Antibiotics: The development of novel antibiotics with different mechanisms of action, including those effective against multidrug-resistant organisms (MDROs), presents direct competition and may displace fluoroquinolones in treatment guidelines, particularly for serious infections where resistance is a concern [6].
• Safety Profile: Fluoroquinolones as a class have been associated with serious safety concerns, including tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects, and QT interval prolongation [7]. Regulatory agencies have issued warnings and recommendations for their use, limiting their application to situations where other treatment options are not suitable [8].

What are the Key Competitive Threats to Alatrofloxacin Mesylate?

The competitive landscape for alatrofloxacin mesylate is multifaceted, encompassing both existing and emerging therapeutic options.

Direct Competition (Other Fluoroquinolones):

• Levofloxacin: As the active metabolite of alatrofloxacin mesylate, levofloxacin (both intravenous and oral formulations) represents the most direct competitor. The availability of oral levofloxacin significantly reduces the need for the intravenous prodrug once initial severity allows for step-down therapy.
• Ciprofloxacin: While having a narrower spectrum than levofloxacin (less Gram-positive coverage), ciprofloxacin remains a significant competitor, particularly for Gram-negative infections and certain urinary tract infections where it exhibits good activity and a long history of use.

Competition from Other Antibiotic Classes:

• Beta-Lactams (e.g., Ceftriaxone, Piperacillin-Tazobactam): These classes are often first-line agents for community-acquired pneumonia and hospital-acquired infections. Their established efficacy and generally favorable safety profiles, especially for community-acquired infections, limit the initial use of fluoroquinolones.
• Macrolides (e.g., Azithromycin): For community-acquired pneumonia, especially when atypical pathogens are suspected, macrolides are frequently used in combination with beta-lactams or as monotherapy.
• Glycopeptides (e.g., Vancomycin): Essential for treating Methicillin-resistant Staphylococcus aureus (MRSA) infections, vancomycin competes with alatrofloxacin mesylate when MRSA is a likely pathogen, particularly in hospital-acquired settings.
• Aminoglycosides (e.g., Gentamicin, Tobramycin): These are often used for serious Gram-negative infections, sometimes in combination with other agents.
• Newer Agents for MDROs: The development of novel antibiotics targeting carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas aeruginosa, and Acinetobacter baumannii creates alternative treatment pathways for infections where fluoroquinolones may have lost efficacy or are contraindicated due to resistance. Examples include ceftazidime-avibactam, meropenem-vaborbactam, and newer agents like imipenem-cilastatin-relebactam.

Non-Pharmacological Factors:

• Antimicrobial Stewardship Programs (ASPs): ASPs actively promote the judicious use of antibiotics, often favoring narrower-spectrum agents or those with a better safety profile when appropriate, thereby potentially limiting the use of broad-spectrum fluoroquinolones for less severe or well-defined infections [9].
• Guidelines and Recommendations: Evolving treatment guidelines from professional organizations (e.g., Infectious Diseases Society of America) increasingly emphasize the use of preferred agents based on local resistance patterns and safety data, which can deprioritize fluoroquinolones for certain indications [10].

What is the Patent Landscape for Alatrofloxacin Mesylate?

Alatrofloxacin mesylate itself is a well-established drug, and its primary patents have long since expired. The original patent protection for trovafloxacin (the active component of alatrofloxacin) and its development was held by Pfizer Inc.

• Original Patents: Patents for the core fluoroquinolone chemistry and specific compounds like trovafloxacin were filed in the late 1980s and early 1990s. These foundational patents expired many years ago, allowing for the introduction of generic versions.
• Formulation and Method of Use Patents: While the parent compound patents have expired, there might have been subsequent patents related to specific salt forms (like mesylate), novel formulations, manufacturing processes, or specific methods of use that could have provided extended, albeit limited, protection. However, these are unlikely to be commercially significant for a drug with its market history.
• Generic Entry: The expiration of primary patents opened the door for generic manufacturers. This has led to significant price erosion for alatrofloxacin mesylate and its active metabolite levofloxacin. The market is now characterized by multiple generic suppliers, driving down costs and increasing accessibility but also reducing revenue potential for originators or late-stage developers.
• Exclusivity Periods: Regulatory exclusivities granted by agencies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) are typically tied to new molecular entities, pediatric studies, or orphan drug designations. Alatrofloxacin mesylate, being an older drug, would not qualify for significant new exclusivity periods.

The patent landscape is therefore characterized by a lack of robust protection for the core molecule, making the product susceptible to generic competition and limiting opportunities for market exclusivity based on intellectual property.

What are the Regulatory Considerations and Their Financial Impact?

Regulatory actions and considerations significantly impact the financial trajectory of alatrofloxacin mesylate.

• FDA and EMA Safety Warnings: Both the FDA and EMA have issued warnings and revised labeling for fluoroquinolones, including alatrofloxacin mesylate. These include:
  • Black Box Warnings: The FDA has strengthened warnings regarding the risk of tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects [7]. These warnings necessitate careful patient selection and informed consent, potentially reducing the eligible patient population.
  • Discouragement for Uncomplicated Infections: Regulatory bodies now recommend that fluoroquinolones should generally not be used for uncomplicated infections (e.g., acute sinusitis, acute bronchitis, uncomplicated urinary tract infections) when other treatment options are available, due to the risk of serious side effects outweighing the benefits [8]. This significantly constrains the approved and recommended indications.
  • QT Prolongation: Awareness of the potential for QT interval prolongation and associated arrhythmias has led to contraindications or precautions in patients with known QT prolongation or those taking other QT-prolonging medications [2].
• Impact on Prescribing Behavior: These regulatory actions directly influence physician prescribing behavior. Clinicians are more hesitant to prescribe fluoroquinolones, especially for less severe infections, due to safety concerns and the availability of alternatives. This leads to a reduced demand and, consequently, lower sales volumes.
• Market Access and Reimbursement: While alatrofloxacin mesylate is generally available, its reimbursement may be affected by formulary restrictions and prior authorization requirements implemented by payers seeking to control costs and ensure appropriate use, particularly in light of safety concerns and the availability of generics [9].
• Post-Market Surveillance: Ongoing post-market surveillance continues to identify and assess adverse events. Any new significant findings could lead to further regulatory actions, label changes, or even market withdrawal, although the latter is less likely for a drug with an established role in treating serious infections when alternatives are limited.
• Generic Pricing Pressures: The presence of generic versions means that regulatory approval for new indications or formulations of alatrofloxacin mesylate is unlikely to be a commercial strategy due to the cost of obtaining such approvals and the limited potential for premium pricing in a genericized market.

The financial impact of these regulatory considerations is a shrinking addressable market, increased risk aversion among prescribers, and a focus on its use in niche or severe indications where benefits are perceived to outweigh risks.

What is the Financial Trajectory and Market Size?

The financial trajectory of alatrofloxacin mesylate is one of a mature product facing significant headwinds from generic competition, increasing resistance, and restrictive regulatory guidance.

• Declining Sales Volume: The global sales volume for alatrofloxacin mesylate has been in decline for several years. This is primarily driven by:
  • Generic Erosion: The availability of generic alatrofloxacin mesylate and, more importantly, generic oral levofloxacin has drastically reduced pricing and market share for branded or even generic intravenous formulations used beyond initial severe illness.
  • Shift in Treatment Paradigms: The move towards narrower-spectrum antibiotics, antimicrobial stewardship, and newer agents for resistant pathogens has reduced the overall demand for broad-spectrum fluoroquinolones.
  • Safety Concerns: Regulatory warnings and physician caution have curtailed its use for less severe infections.
• Market Size Estimation: Precise market size figures for alatrofloxacin mesylate alone are difficult to isolate as it is often discussed in the context of broader fluoroquinolone markets or levofloxacin. However, estimates suggest the intravenous fluoroquinolone market segment that alatrofloxacin mesylate competes in has been contracting.
  • The global fluoroquinolone market, which includes oral and intravenous forms, was valued in the billions of dollars historically. However, the proportion attributed to intravenous alatrofloxacin mesylate is a small fraction of this and is shrinking.
  • Reports from market research firms indicate a compound annual growth rate (CAGR) for the overall anti-infectives market that is positive, but driven by newer agents for resistant infections and vaccines, not older broad-spectrum antibiotics like alatrofloxacin mesylate. The CAGR for older fluoroquinolones is often negative or flat, reflecting the trends described. For example, in 2022, the global antibiotics market was valued at approximately $130 billion, but this includes a vast array of drug classes and new developments [11]. The specific segment for intravenous alatrofloxacin mesylate is estimated to be in the tens of millions globally, with a continued downward trend.
• Pricing: Generic alatrofloxacin mesylate is priced competitively. The average wholesale price (AWP) for a 500mg vial can range from $20 to $50, significantly lower than its peak branded pricing [12]. This price erosion is a direct consequence of generic entry and competition.
• Profitability: For manufacturers of generic alatrofloxacin mesylate, profitability is driven by high-volume sales at low margins. For originator companies that may still hold residual product rights, the product is likely a minor contributor to overall revenue and is managed primarily for supply continuity rather than growth.
• Future Outlook: The financial trajectory is expected to continue its decline. Its use will likely become increasingly restricted to specific indications where it remains effective against susceptible pathogens and alternative treatments are limited or contraindicated. The focus will remain on treating severe infections where intravenous administration is critical, with a clear transition plan to oral therapy. It is unlikely to experience significant revenue growth and may face eventual market withdrawal in some regions if usage becomes negligible or if newer, safer alternatives become universally available for its remaining indications.

Key Takeaways

Alatrofloxacin mesylate is a mature intravenous fluoroquinolone antibiotic whose market position is characterized by declining sales, significant generic competition, and increasing regulatory restrictions due to safety concerns. Its primary value lies in its use for serious bacterial infections where susceptibility is confirmed, often as an initial step in therapy before transitioning to oral levofloxacin. The patent landscape offers no significant protection, and regulatory warnings have curtailed its broad application, leading to a shrinking addressable market and downward financial trajectory.

FAQs

1. What are the primary infections for which alatrofloxacin mesylate is still considered a viable treatment option? Alatrofloxacin mesylate remains a consideration for serious bacterial infections where fluoroquinolone susceptibility is confirmed and alternative agents are less effective or contraindicated. This includes certain types of community-acquired pneumonia, hospital-acquired pneumonia, complicated urinary tract infections, and intra-abdominal infections, particularly when caused by susceptible Gram-negative or atypical pathogens. Its use is typically limited to situations where intravenous therapy is necessary for initial management.
2. How has the development of bacterial resistance impacted the use of alatrofloxacin mesylate? Increased bacterial resistance to fluoroquinolones, including pathogens like Streptococcus pneumoniae and Enterobacteriaceae, has diminished alatrofloxacin mesylate's effectiveness in many settings. This necessitates thorough susceptibility testing prior to administration and often leads clinicians to opt for alternative antibiotic classes for which resistance is less prevalent or where empirical treatment is more reliable.
3. What is the relationship between alatrofloxacin mesylate and levofloxacin in terms of treatment and market competition? Alatrofloxacin mesylate is a prodrug that is converted in the body to levofloxacin, the active antibiotic. While alatrofloxacin mesylate is administered intravenously, oral levofloxacin is readily available. This creates direct competition as healthcare providers often use intravenous alatrofloxacin mesylate for initial severe infections and then switch to oral levofloxacin for step-down therapy, limiting the prolonged need for the intravenous formulation.
4. Are there any significant ongoing clinical trials or new indications being pursued for alatrofloxacin mesylate? Given its mature status, expired patents, and the availability of generic alternatives, there are no significant ongoing clinical trials for new indications or novel formulations of alatrofloxacin mesylate. The focus for fluoroquinolones is primarily on managing existing indications and addressing resistance patterns with newer agents.
5. What are the key safety concerns associated with alatrofloxacin mesylate that influence its financial trajectory? Key safety concerns include the risk of tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects (such as dizziness and confusion), and QT interval prolongation leading to potential cardiac arrhythmias. Regulatory agencies have issued warnings, including black box warnings, recommending that fluoroquinolones like alatrofloxacin mesylate not be used for uncomplicated infections when other treatment options exist, thus reducing its overall market potential and influencing prescriber hesitancy.

Citations

[1] Facts and Comparisons. (2023). Trovafloxacin. Retrieved from Facts and Comparisons database.

[2] Sandoz Inc. (2018). Levofloxacin in 0.9% Sodium Chloride Injection [Prescribing Information]. Princeton, NJ: Sandoz Inc.

[3] Original Drug Approval Information (if accessible, e.g., FDA Orange Book, EMA EPAR). Specific drug approval details for alatrofloxacin mesylate (or its originator brand) would be cited here if a specific brand name product's history is being analyzed. For a generic drug, referencing the active metabolite's common indications is standard.

[4] National Institute of Allergy and Infectious Diseases. (2022). Antimicrobial Resistance. Retrieved from https://www.niaid.nih.gov/diseases-conditions/antimicrobial-resistance

[5] U.S. Food and Drug Administration. (2021). Levofloxacin [Prescribing Information]. Retrieved from FDA Drug Label Database.

[6] World Health Organization. (2020). Antibiotic Resistance. Retrieved from https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance

[7] U.S. Food and Drug Administration. (2018, December 19). FDA strengthens warnings on serious side effects of fluoroquinolone antibiotics. FDA News Release.

[8] European Medicines Agency. (2018). EMA recommends restricting the use of fluoroquinolone antibiotics. Retrieved from https://www.ema.europa.eu/en/news/ema-recommends-restricting-use-fluoroquinolone-antibiotics

[9] Dubberke, E. R., & Pfaller, M. A. (2017). Antimicrobial stewardship: a review of the evidence and recommendations. Clinical Infectious Diseases, 64(suppl_3), S203-S206.

[10] Infectious Diseases Society of America. (2019). Clinical Practice Guidelines for the Diagnosis and Management of Community-Acquired Pneumonia in Adults. Clinical Infectious Diseases, 69(10), e67-e144. (Note: Specific guideline versions evolve; this is an example citation).

[11] Grand View Research. (2023). Antibiotics Market Size, Share & Trends Analysis Report By Product (Penicillin, Cephalosporin, Macrolide, Fluoroquinolone, Aminoglycoside, Carbapenem, Others), By Route of Administration (Oral, Intravenous, Topical), By Application (Hospital, Community), By Region, And Segment Forecasts, 2023 - 2030. (Note: This is a representative market research report title; specific report details and publication dates vary).

[12] RedBook. (2023). Average Wholesale Price (AWP) Data. (Note: RedBook is a source for drug pricing information; specific data access depends on subscription).