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Last Updated: March 26, 2026

Gentamicin sulfate; prednisolone acetate - Generic Drug Details


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What are the generic drug sources for gentamicin sulfate; prednisolone acetate and what is the scope of patent protection?

Gentamicin sulfate; prednisolone acetate is the generic ingredient in one branded drug marketed by Allergan and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for gentamicin sulfate; prednisolone acetate
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
DailyMed Link:gentamicin sulfate; prednisolone acetate at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for gentamicin sulfate; prednisolone acetate
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D06AX Other antibiotics for topical use
D06A ANTIBIOTICS FOR TOPICAL USE
D06 ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D Dermatologicals
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02AA Antiinfectives
S02A ANTIINFECTIVES
S02 OTOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for gentamicin sulfate; prednisolone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan PRED-G gentamicin sulfate; prednisolone acetate OINTMENT;OPHTHALMIC 050612-001 Dec 1, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Allergan PRED-G gentamicin sulfate; prednisolone acetate SUSPENSION/DROPS;OPHTHALMIC 050586-001 Jun 10, 1988 DISCN Yes 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

Gentamicin sulfate; prednisolone acetate Market Analysis and Financial Projection

Last updated: February 15, 2026

Market Dynamics and Financial Trajectory for Gentamicin Sulfate and Prednisolone Acetate

Market Overview

Gentamicin sulfate and prednisolone acetate are widely used pharmaceuticals with distinct roles. Gentamicin sulfate is an aminoglycoside antibiotic primarily used for serious bacterial infections. Prednisolone acetate is a corticosteroid predominantly prescribed for inflammation and allergy management.

Market Size and Growth

Gentamicin Sulfate

  • Estimated global market value in 2022: $360 million.
  • Compound annual growth rate (CAGR): approximately 2.5% through 2028 (sources: Research and Markets, 2022).
  • Market drivers include rising bacterial infections, increasing antibiotic consumption, and expanding hospital-based treatments.
  • Key geographic markets: North America (35%), Europe (25%), Asia-Pacific (20%), rest of world.

Prednisolone Acetate

  • Estimated global market value in 2022: $1.2 billion.
  • CAGR: approximately 4% forecasted through 2028.
  • Growth driven by rising prevalence of inflammatory disorders, including arthritis, asthma, and dermatological conditions.
  • Key markets: North America (40%), Europe (30%), Asia-Pacific (15%).

Pricing Trends and Revenue Streams

Gentamicin Sulfate

  • Pricing historically stable but subject to generic competition.
  • Average retail price per vial (100 mg): $5-$8.
  • Hospital procurement accounts for over 80% of sales, with bulk purchasing influencing margins.

Prednisolone Acetate

  • Pricing varies by formulation and brand.
  • Cost per 1% ophthalmic suspension (15 mL): approximately $10-$15.
  • Sales are distributed across ophthalmology clinics, hospitals, and pharmacies.

Competitive Landscape

Gentamicin Sulfate

  • Major players: Pfizer, Teva, Sandoz, Sun Pharmaceutical.
  • Entry barrier: High manufacturing costs, regulatory hurdles.
  • Generic market dominant; limited innovation recent years.

Prednisolone Acetate

  • Major companies: Bausch + Lomb, Alcon, Santen, generic players.
  • Innovation: Focus on delivery systems, such as sustained-release ophthalmic formulations.
  • Market fragmentation with multiple generic brands.

Regulatory Environment and Patents

  • Gentamicin sulfate's patents largely expired by 2010.
  • Prednisolone formulations face patent expiration timelines between 2020 and 2024.
  • Regulatory standards upheld by FDA, EMA, and other agencies influence market entry and product approvals.

Financial Trajectory and Investment Outlook

Gentamicin Sulfate

  • Revenue growth stabilizing due to market saturation and generic competition.
  • Margins compressed; manufacturers focus on cost reduction.
  • Future growth limited absent new formulations or delivery methods.

Prednisolone Acetate

  • Ongoing innovation in formulation technology can drive growth.
  • Expected revenue increase, given rising demand in emerging markets.
  • Competitive pressures influence pricing strategies.

Strategic Opportunities

  • Development of new delivery systems for corticosteroids.
  • Expanding use in emerging markets with improving healthcare infrastructure.
  • Differentiation through patent protection or novel formulations for antibiotics.

Key Takeaways

  • Gentamicin sulfate’s market is stable with slow growth, dominated by generics.
  • Prednisolone acetate exhibits more dynamic growth prospects, driven by inflammation management needs.
  • Pricing for both drugs remains pressured by generics, but innovation may offer differentiation.
  • Regulatory and patent expirations influence market entry and competitive dynamics.
  • Investment in advanced delivery methods or combination therapies could create new revenue streams.

FAQs

Q1: What factors limit the growth of gentamicin sulfate?
A1: Generic competition, patent expirations, and market saturation limit growth potential.

Q2: Which regions present the highest growth opportunities for prednisolone acetate?
A2: Emerging markets in Asia-Pacific and Latin America due to rising prevalence of inflammatory diseases.

Q3: How has patent expiration affected the gentamicin sulfate market?
A3: It has increased generic entry, lowered prices, and reduced profit margins for branded manufacturers.

Q4: Are there innovations in delivery systems for prednisolone acetate?
A4: Yes, sustained-release ophthalmic formulations and new delivery devices are under development.

Q5: How might regulatory changes influence future market dynamics?
A5: Stringent approval standards can delay new product launches; conversely, fast-track pathways may accelerate innovation adoption.


References

  1. Research and Markets. (2022). Global Gentamicin Market Report.
  2. MarketsandMarkets. (2022). Corticosteroids Market Forecast to 2028.
  3. US Food and Drug Administration (FDA). (2023). Drug Approvals and Patent Expirations.
  4. IQVIA. (2022). Top Pharmaceutical Markets and Trends.
  5. Scrip. (2022). Emerging Innovations in Ophthalmic Drug Delivery.

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