Aminoglycoside Antibacterial Drug Class List

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
Novartis	TOBREX	tobramycin	OINTMENT;OPHTHALMIC	050555-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Sandoz	TOBREX	tobramycin	SOLUTION/DROPS;OPHTHALMIC	062535-001	Dec 13, 1984	AT	RX	No	No
Gland	TOBRAMYCIN SULFATE (PHARMACY BULK)	tobramycin sulfate	INJECTABLE;INJECTION	209346-001	Feb 9, 2021	AP	RX	No	No
Fresenius Kabi Usa	TOBRAMYCIN SULFATE (PHARMACY BULK)	tobramycin sulfate	INJECTABLE;INJECTION	065120-001	Nov 29, 2002	AP	RX	No	Yes
Hospira	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063111-001	Apr 30, 1991	AP	RX	No	No

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:

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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].

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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].

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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].

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

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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