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Last Updated: May 24, 2025

Aminoglycoside Antibacterial Drug Class List


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Drugs in Drug Class: Aminoglycoside Antibacterial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb ZYLET loteprednol etabonate; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050804-001 Dec 14, 2004 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis TOBREX tobramycin OINTMENT;OPHTHALMIC 050555-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz TOBREX tobramycin SOLUTION/DROPS;OPHTHALMIC 062535-001 Dec 13, 1984 AT RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gland TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 209346-001 Feb 9, 2021 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Fresenius Kabi Usa TOBRAMYCIN SULFATE (PHARMACY BULK) tobramycin sulfate INJECTABLE;INJECTION 065120-001 Nov 29, 2002 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063111-001 Apr 30, 1991 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Aminoglycoside Antibacterial Market Analysis and Financial Projection

The aminoglycoside antibiotics market is experiencing steady growth, driven by rising bacterial infections and innovations in drug development. Valued at $1.05 billion in 2023, it is projected to reach $1.31–$2.9 billion by 2033, with a CAGR of 4–6.3% depending on regional dynamics[1][6][14]. Below is a detailed analysis of market forces and patent developments shaping this therapeutic class:


Market Dynamics

Growth Drivers

  1. Antimicrobial Resistance (AMR) and Gram-Negative Pathogens
    Increasing multidrug-resistant bacterial infections (e.g., Pseudomonas aeruginosa, Acinetobacter) have revived interest in aminoglycosides like gentamicin and amikacin. Their broad-spectrum efficacy against resistant strains positions them as critical second-line therapies[1][11][17].

  2. Healthcare Infrastructure and Regional Demand

    • North America: Holds ~41.5% market share due to advanced healthcare systems, high antibiotic stewardship, and R&D investments[1][18].
    • Asia-Pacific: Fastest-growing region (6.3% CAGR) driven by rising TB cases, increased healthcare spending, and generic manufacturing post-patent expirations[1][4][18].
  3. Veterinary Applications
    Use in treating livestock infections (e.g., anthrax outbreaks) and zoonotic diseases contributes to 4.9% CAGR growth in veterinary segments[3][6].

Key Challenges

  • Toxicity Concerns: Ototoxicity and nephrotoxicity limit prescription rates, necessitating therapeutic drug monitoring[14][16].
  • Generic Competition: Patent expirations (e.g., US8318685B2) have enabled generic production, particularly in Asia-Pacific, reducing profit margins for originators[8][18].

Innovation Trends

  • Novel Formulations: Inhalable tobramycin (US8715623) and intravesical instillations improve delivery for respiratory/urinary infections[16][18].
  • Personalized Medicine: Genomic tools enable dose optimization to mitigate toxicity[7].
  • Combination Therapies: Paired with β-lactams or vancomycin to enhance efficacy against resistant pathogens[4][14].

Patent Landscape

Major Patents and Innovations

Patent Number Focus Area Assignee Status/Impact
US9688711B2 Novel aminoglycoside analogs Achaogen, Inc. Active (2017–2037); targets multidrug-resistant Gram-negative bacteria[2][10].
US9266919B2 Sisomicin derivatives Achaogen, Inc. Expired (2016); spurred generic competition in Asia[13][15].
US8715623 Pulmonary delivery systems Novartis AG Enabled inhaled tobramycin for cystic fibrosis[16].
US20230097398A1 Genetic disorder applications Abandoned Highlighted repurposing potential beyond bacterial infections[9].

Strategic Shifts in R&D

  • Resistance-Reversal Compounds: Recent patents focus on modifying aminoglycosides to evade bacterial acetyltransferases and phosphotransferases[15].
  • Non-Antibiotic Applications: Exploratory use in treating genetic disorders (e.g., nonsense mutations) and fungal/viral infections[9][15].

Competitive Outlook

  • Top Players: Pfizer, Cipla, Teva, and Zoetis dominate through generics and strategic approvals (e.g., Cipla’s ZEMDRI in India)[3][18].
  • Litigation: Cases like T0500/12 (European Patent Office) address method-of-use claims, reflecting disputes over screening technologies involving aminoglycosides[12].

"The development of innovative aminoglycoside-based therapies, including novel formulations and derivatives, is critical to addressing the global AMR crisis." – Market Analysis Report[1].


Future Prospects

  1. Antibiotic Stewardship Programs: Promote targeted use, sustaining demand while curbing resistance[1][14].
  2. Emerging Markets: Untapped potential in Africa and Latin America for affordable generics[1][4].
  3. Biotechnological Advances: CRISPR and synthetic biology could yield next-gen aminoglycosides with improved safety profiles[6][15].

This evolving landscape underscores aminoglycosides’ enduring relevance amid escalating resistance, balanced by innovation in drug delivery and toxicity management.

References

  1. https://datahorizzonresearch.com/aminoglycosides-antibiotics-market-4716
  2. https://www.drugpatentwatch.com/p/patent/9688711
  3. https://www.openpr.com/news/3884569/global-aminoglycosides-market-to-reach-2-5-billion-by-2029
  4. https://www.researchandmarkets.com/reports/5785580/aminoglycosides-market-report
  5. https://patents.google.com/patent/US9266919B2/en
  6. https://www.gminsights.com/industry-analysis/aminoglycosides-market
  7. https://www.imarcgroup.com/aminoglycosides-market
  8. https://patents.google.com/patent/US8318685B2/en
  9. https://patents.google.com/patent/US20230097398A1/en
  10. https://pubchem.ncbi.nlm.nih.gov/patent/US-9688711-B2
  11. https://www.mordorintelligence.com/industry-reports/aminoglycosides-market/market-size
  12. https://www.epo.org/en/boards-of-appeal/decisions/t120500eu1
  13. https://pubchem.ncbi.nlm.nih.gov/patent/US9266919
  14. https://market.us/report/aminoglycosides-market/
  15. https://pmc.ncbi.nlm.nih.gov/articles/PMC4806794/
  16. https://www.drugpatentwatch.com/p/patent/8715623
  17. https://www.grandviewresearch.com/industry-analysis/aminoglycoside-market
  18. https://www.mordorintelligence.com/industry-reports/aminoglycosides-market
Last updated: 2025-03-23

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