Last Updated: August 3, 2026

Lomefloxacin hydrochloride - Generic Drug Details


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What are the generic drug sources for lomefloxacin hydrochloride and what is the scope of patent protection?

Lomefloxacin hydrochloride is the generic ingredient in one branded drug marketed by Pharmacia and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for lomefloxacin hydrochloride.

Summary for lomefloxacin hydrochloride
Recent Clinical Trials for lomefloxacin hydrochloride

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

SponsorPhase
James Graham Brown Cancer CenterEarly Phase 1
Julio RamirezEarly Phase 1
University of LouisvilleEarly Phase 1

See all lomefloxacin hydrochloride clinical trials

US Patents and Regulatory Information for lomefloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia MAXAQUIN lomefloxacin hydrochloride TABLET;ORAL 020013-001 Feb 21, 1992 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: February 14, 2026

What are the current market dynamics for lomefloxacin hydrochloride?

Lomefloxacin hydrochloride is a fluoroquinolone antibiotic used primarily to treat urinary tract infections, respiratory infections, and skin infections. Its market has been influenced by the broader antibiotic sector, regulatory considerations, and antimicrobial resistance concerns.

Market Size and Growth

  • The global fluoroquinolone market, including drugs like lomefloxacin hydrochloride, was valued at approximately $3 billion in 2022.
  • Projected compound annual growth rate (CAGR) for fluoroquinolones is around 2-3% through 2028, driven by infection prevalence and evolving resistance patterns [1].
  • Lomefloxacin’s specific market share remains limited due to competition from newer agents and safety concerns.

Key Drivers

  • Infection Treatment Needs: Rising prevalence of urinary and respiratory infections sustains demand.
  • Clinical Guidelines: Adoption by healthcare protocols influences prescribing patterns.
  • Antimicrobial Resistance: Growing resistance to older antibiotics may pivot preferences towards newer or less-used fluoroquinolones, affecting lomefloxacin’s market penetration.

Market Challenges

  • Safety Profile: Black box warnings and adverse effects linked to fluoroquinolones restrict their use.
  • Regulatory Restrictions: Several countries impose usage restrictions on fluoroquinolones, impacting sales.
  • Generic Competition: Multiple generics lower prices, reducing profit margins for branded formulations.

Regional Trends

  • North America: Market limited by regulatory caution; generic presence dominates.
  • Europe: Stringent regulations decrease usage; focus shifts to newer antibiotics.
  • Asia-Pacific: Higher infection rates and lower regulatory restrictiveness keep demand relatively stable.

What is the financial trajectory of lomefloxacin hydrochloride?

Lomefloxacin hydrochloride’s financial profile is characterized by declining sales in mature markets and limited growth prospects.

Revenue Contributions

  • Lomefloxacin remains a minor commodity within the fluoroquinolone sector.
  • Estimated annual sales are under $50 million globally, with major contributions from China, India, and some Southeast Asian countries.
  • Major pharmaceutical companies no longer prioritize marketing lomefloxacin actively, reducing promotional funding.

Profitability Outlook

  • Margins are squeezed by generic competition and price erosion.
  • Manufacturing costs are relatively stable but may be offset by declining sales volume.
  • Patent expirations in many regions have led to increased generic availability, further driving down prices.

Investment and R&D Trends

  • Pharmaceutical companies have largely deprioritized R&D for lomefloxacin due to safety concerns and limited growth.
  • Industry focus shifts toward novel antibiotics with broader spectrum or improved safety profiles.
  • New developments target resistance mitigation and targeted therapies, leaving older fluoroquinolones like lomefloxacin on decline.

Regulatory Implications

  • Restrictions in Europe and North America limit potential revenue growth.
  • Variations in approval status across countries create a fragmented revenue landscape.
  • Regulatory agencies such as the FDA and EMA discourage off-label use, constraining market expansion.

How does lomefloxacin hydrochloride compare with other fluoroquinolones?

Drug Market Size (2022) Safety Concerns Regulatory Status Typical Uses
Ciprofloxacin >$1 billion Moderate Widely approved Urinary, gastrointestinal
Levofloxacin ~$1 billion Moderate Approved globally Respiratory, urinary
Lomefloxacin <$50 million High Restricted in some markets Urinary, respiratory (limited)

Lomefloxacin’s market share lags behind ciprofloxacin and levofloxacin due to safety issues and limited regulatory approval.

Key drivers and inhibitors shaping the market and financial trajectory

  • Drivers: Growing infection rates in developing regions, clinical practice adherence.
  • Inhibitors: Safety and resistance issues, regulatory restrictions, generic price competition.

Key takeaways

  • The lomefloxacin hydrochloride market remains small and in decline.
  • Market growth is limited by safety concerns, regulatory restrictions, and increased generic competition.
  • The pharmaceutical industry is de-emphasizing lomefloxacin R&D in favor of new antibiotics with better safety profiles.
  • Regional disparities influence sales: stronger in Asia-Pacific, weaker in North America and Europe.
  • Future prospects are minimal unless new formulations address safety issues or resistance patterns change.

FAQs

1. Will lomefloxacin hydrochloride regain market share?
Unlikely, given its safety profile and current regulatory landscape. Shift toward newer antibiotics limits potential growth.

2. Are there ongoing R&D efforts to improve lomefloxacin?
No significant R&D initiatives targeting modifications or improvements are publicly known.

3. How do regulatory restrictions impact sales?
Restrictions limit prescribing options, reduce off-label use, and diminish market size especially in Europe and North America.

4. What regions present growth opportunities?
Asia-Pacific remains the primary market due to higher infection rates and less restrictive regulations.

5. How does antimicrobial resistance influence the market?
Rising resistance to older fluoroquinolones increases demand for novel agents, further marginalizing older drugs like lomefloxacin.

References

[1] MarketWatch. "Fluoroquinolone Antibiotics Market Size, Share & Trends Analysis." 2022.

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