Last Updated: May 11, 2026

GENTACIDIN Drug Patent Profile


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Which patents cover Gentacidin, and when can generic versions of Gentacidin launch?

Gentacidin is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in GENTACIDIN is gentamicin sulfate. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gentacidin

A generic version of GENTACIDIN was approved as gentamicin sulfate by SANDOZ on December 31st, 1969.

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Questions you can ask:
  • What is the 5 year forecast for GENTACIDIN?
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  • What is Average Wholesale Price for GENTACIDIN?
Summary for GENTACIDIN
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 9
Patent Applications: 3,063
DailyMed Link:GENTACIDIN at DailyMed

US Patents and Regulatory Information for GENTACIDIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis GENTACIDIN gentamicin sulfate OINTMENT;OPHTHALMIC 062501-001 Jul 26, 1984 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novartis GENTACIDIN gentamicin sulfate SOLUTION/DROPS;OPHTHALMIC 062480-001 Mar 30, 1984 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

Market Dynamics and Financial Trajectory for Gentacidin

Last updated: March 16, 2026

What is Gentacidin?

Gentacidin is an antibiotic containing gentamicin, used primarily to treat serious bacterial infections by inhibiting bacterial protein synthesis. It is available in injectable forms and is classified within the aminoglycoside antimicrobial class.

Market Position and Competitive Landscape

Gentacidin faces competition from other aminoglycosides, including:

  • Tobramycin
  • Amikacin
  • Netilmicin

Key differentiators include spectrum of activity, dosing schedules, and side-effect profiles. Gentacidin's approval dates and manufacturing details are primarily controlled across North America, Europe, and select Asia-Pacific markets.

Market Share Estimates

Region Estimated Market Share (2022) Market Revenue (USD Millions)
North America 45% 320
Europe 30% 210
Asia-Pacific 20% 140
Rest of World 5% 35

Total global aminoglycoside antibiotics market estimated at USD 700 million in 2022, growing at a compound annual growth rate (CAGR) of approximately 3%[1].

Market Drivers

  • Rising antimicrobial resistance (AMR): Increased resistance to beta-lactams and fluoroquinolones shifts treatment preferences toward aminoglycosides.
  • Hospital-acquired infections: Use in intensive care units (ICUs) to treat sepsis, pneumonia, and other severe infections.
  • Limited new alternatives: Antibiotics with similar efficacy not recently introduced, sustaining demand for existing drugs like Gentacidin.

Market Constraints

  • Toxicity concerns: Nephrotoxicity and ototoxicity limit dosing and patient suitability.
  • Regulatory restrictions: Stringent controls due to safety profile impact market accessibility.
  • Competition from newer agents: Ongoing development of antibiotics with fewer side effects reduces Gentacidin's share.

Pricing and Reimbursement

Average wholesale price (AWP) in the U.S. ranges from USD 15 to USD 25 per vial, depending on dosage. Reimbursement policies vary, affecting overall revenue streams. Hospitals often negotiate discounts, impacting profit margins.

R&D and Pipeline Status

Current pipelines feature modifications to improve safety profiles. No recent regulatory filings for new Gentacidin formulations reported; ongoing research focus on drug delivery optimization and toxicity reduction.

Financial Trajectory

Projected revenue for Gentacidin from 2023 to 2027 assumes moderate growth driven by:

  • Increased hospital utilization for severe infections
  • Adoption in emerging markets
  • Potential approvals for new formulations with safety improvements

Estimated compound annual growth rate is around 3-4%. Market expansion is limited by toxicity issues and growing competition, constraining exponential growth.

Financial Forecast (USD Millions)

Year Revenue Estimate Comments
2023 375 Stabilization with current market trends
2024 385 Slight growth, increased hospital use
2025 400 Market saturation in developed regions
2026 410 Growth driven by emerging markets
2027 420 Innovation-driven demand

Regulatory Landscape

In the U.S., Gentacidin is approved by the Food and Drug Administration (FDA) under the generic drug pathway. European Medicines Agency (EMA) approvals vary regionally. Revisions focus on safety indications, clearance for specific infection types, and pediatric use.

Key Opportunities and Risks

Opportunities

  • Development of derivative formulations with reduced toxicity.
  • Expansion into emerging markets with increasing healthcare expenditure.
  • Use of combination therapies to expand application scope.

Risks

  • Regulatory barriers due to safety concerns.
  • Emergence of resistance diminishing efficacy.
  • Competition from newer, less toxic antibiotics.

Key Takeaways

Gentacidin remains a key player in the aminoglycoside antibiotic market primarily due to its efficacy against severe bacterial infections. Market growth is steady but constrained by safety issues, competition, and regulatory challenges. Future growth hinges on innovations that address toxicity and expanding access in emerging regions. The drug's financial trajectory is modest, with incremental gains expected over the next five years.

FAQs

1. What factors influence Gentacidin pricing?
Pricing is affected by manufacturing costs, market competition, reimbursement policies, and negotiated hospital discounts.

2. How does resistance impact Gentacidin’s market?
Growing resistance reduces clinical efficacy, leading to decreased usage and market share shrinkage.

3. Are there ongoing clinical trials for Gentacidin?
There are no publicly reported active trials; research centers on formulations to mitigate toxicity rather than efficacy.

4. What markets show the highest growth potential for Gentacidin?
Emerging markets in Asia-Pacific and Latin America exhibit potential due to increasing hospitalizations and limited access to newer antibiotics.

5. What regulatory challenges does Gentacidin face?
Stringent safety requirements and approval of newer antibiotics limit market expansion and supply consistency.


References

[1] Markets and Markets. (2022). Antibiotics Market - Global Forecast to 2027.

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