Drugs in ATC Class J01GB

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Up to J01G - AMINOGLYCOSIDE ANTIBACTERIALS

Drugs in ATC Class: J01GB - Other aminoglycosides

Tradename	Generic Name
TOBRADEX	dexamethasone; tobramycin
TOBRADEX ST	dexamethasone; tobramycin
TOBRAMYCIN AND DEXAMETHASONE	dexamethasone; tobramycin
TOBRASONE	fluorometholone acetate; tobramycin
ZYLET	loteprednol etabonate; tobramycin
TOBREX	tobramycin
TOBI PODHALER	tobramycin

J01GB Market Analysis and Financial Projection

Last updated: March 23, 2025

The ATC class J01GB (Other aminoglycosides) encompasses antibiotics like gentamicin, tobramycin, amikacin, and neomycin, which are critical for treating serious bacterial infections. Below is an analysis of their market dynamics and patent landscape:

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Market Dynamics

Growth Trends

• Current Valuation: Estimated at $1.8–2.02 billion in 2024, with projections to reach $2.46–2.67 billion by 2029–2030, reflecting a CAGR of 4.8–6.3% [8][12][17].
• Key Drivers:
  • Rising bacterial infections (e.g., respiratory diseases, sepsis) and veterinary use [2][8].
  • Innovations in drug delivery (e.g., inhaled formulations like tobramycin and amikacin for lung infections) [4][6].
  • Government initiatives subsidizing antibiotics in low-resource regions [2][8].

Segment Insights

• Dominant Products: Gentamicin leads with 32.5% market share, favored for its efficacy against Gram-negative bacteria [8].
• Administration Routes: Parenteral (injectable) forms hold 30.8% share due to rapid action in critical care [8].
• Regional Markets:
  • Asia-Pacific (41.5% share): Driven by population growth and healthcare investments [8][16].
  • Europe: Second-largest market, supported by policies promoting antibiotic stewardship [16].

Challenges

• Safety Concerns: Nephrotoxicity and ototoxicity limit prolonged use [8][16].
• Antimicrobial Resistance: While aminoglycosides remain effective against many resistant strains, resistance mechanisms are evolving [2].

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Patent Landscape

Key Patents and Expirations

• Aminoglycoside Analogs: Patents like US-9688711-B2 (expiring 2028–2031) and US-9266919-B2 cover novel compounds and formulations [3][5][14].
• Zemdri (Plazomicin): Protected by patents until 2028–2031, with exclusivities expiring in 2028 [5].
• Inhaled Formulations: Patents for aerosolized tobramycin (e.g., US8715623) emphasize targeted delivery for respiratory infections [11].

Impact of Patent Expiries

• Post-2028, generic competition will intensify, particularly in Asia-Pacific, where large-scale generic manufacturing is already prominent [16].
• Innovations in combination therapies (e.g., aminoglycosides + β-lactams) and personalized dosing may offset generic pressure [12][16].

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Competitive and Regulatory Outlook

• Major Players: Mix of originators (e.g., Novartis, Cipla) and generics manufacturers [5][13][16].
• Strategic Trends:
  • Biotechnological Advancements: Protein synthesis inhibitors and modified analogs to combat resistance [2][12].
  • Antibiotic Stewardship: Emphasis on optimizing use to prolong efficacy [7][12].

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Key Takeaways

• Market Growth: Sustained by infectious disease burden and formulation innovations.
• Patent Cliffs: Post-2028 expiries will reshape the competitive landscape, favoring generics.
• Future Opportunities: Inhalation therapies and combination regimens address unmet needs in critical care and resistant infections.

“The expiry of patent exclusivity has led to large-scale generic manufacturing of aminoglycosides, particularly in Asia-Pacific.” – Globenewswire [16]

References

1. https://www.mdpi.com/2079-6382/12/1/126
2. https://www.gminsights.com/industry-analysis/aminoglycosides-market
3. https://pubchem.ncbi.nlm.nih.gov/patent/US-9688711-B2
4. https://atcddd.fhi.no/atc_ddd_index/?code=J01GB
5. https://pharsight.greyb.com/drug/zemdri-patent-expiration
6. https://atcddd.fhi.no/atc_ddd_index/?code=J01GB&showdescription=no
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC10042087/
8. https://market.us/report/aminoglycosides-market/
9. https://pubchem.ncbi.nlm.nih.gov/compound/441305
10. https://www.mdpi.com/2079-6382/12/7/1109
11. https://www.drugpatentwatch.com/p/patent/8715623
12. https://www.researchandmarkets.com/reports/5785580/aminoglycosides-market-report
13. https://www.drugpatentwatch.com/p/generic/gentamicin+sulfate
14. https://pubchem.ncbi.nlm.nih.gov/patent/US9266919
15. https://www.mdpi.com/1660-4601/16/18/3376
16. http://www.globenewswire.com/news-release/2019/07/12/1882033/0/en/Worldwide-Aminoglycosides-Markets-2019-to-2024-Expiry-of-Patent-Exclusivity-has-Led-to-Large-Scale-Generic-Manufacturing-of-Aminoglycosides-Particularly-in-the-Developing-Region-of.html?culture=en-us
17. https://www.360iresearch.com/library/intelligence/aminoglycosides