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Last Updated: March 26, 2026

Hydrocortisone; neomycin sulfate; polymyxin b sulfate - Generic Drug Details


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What are the generic drug sources for hydrocortisone; neomycin sulfate; polymyxin b sulfate and what is the scope of freedom to operate?

Hydrocortisone; neomycin sulfate; polymyxin b sulfate is the generic ingredient in nine branded drugs marketed by Monarch Pharms, Amneal, Bausch And Lomb, Sandoz, Saptalis Pharms, Pharmafair, Watson Labs, Casper Pharma Llc, Sciegen Pharms, and Schering, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound.

Summary for hydrocortisone; neomycin sulfate; polymyxin b sulfate
Pharmacology for hydrocortisone; neomycin sulfate; polymyxin b sulfate
Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone; neomycin sulfate; polymyxin b sulfate
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
B05 BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B Blood and blood forming organs
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
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
J01XB Polymyxins
J01X OTHER ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01AA Antibiotics
S01A ANTIINFECTIVES
S01 OPHTHALMOLOGICALS
S Sensory organs
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
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
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
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for hydrocortisone; neomycin sulfate; polymyxin b sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmafair OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 062399-001 Nov 18, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Monarch Pharms CORTISPORIN hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 050169-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Monarch Pharms CORTISPORIN hydrocortisone; neomycin sulfate; polymyxin b sulfate SOLUTION/DROPS;OTIC 050479-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sandoz NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 062488-001 Nov 6, 1985 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sandoz NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 062874-001 May 11, 1988 RX No Yes ⤷  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

Hydrocortisone; neomycin sulfate; polymyxin b sulfate Market Analysis and Financial Projection

Last updated: February 16, 2026

Market Dynamics and Financial Trajectory for Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate

Overview of the Drugs

Hydrocortisone, neomycin sulfate, and polymyxin B sulfate are topical and systemic antibiotics and corticosteroids used in various therapeutic areas, including dermatology, infectious diseases, and inflammation management. Their combined formulations are common in OTC and prescription products.

Market Size and Growth

The global pharmaceutical market for corticosteroids and topical antibiotics is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% through 2030. The segment including hydrocortisone and neomycin/poly myxin B compounds is likely to expand driven by increasing demand for inflammatory and infectious disease treatments.

  • Hydrocortisone: Estimated to be a $1.2 billion market in 2022, with a CAGR of 4%, driven by demand in dermatology and endocrine disorder management.

  • Neomycin Sulfate & Polymyxin B Sulfate: The combined segment is valued at around $500 million in 2022, with growth driven by its use in topical antibiotic formulations, especially in hospital and outpatient settings.

Key Market Drivers

  • Increase in dermatological conditions: Rising prevalence of eczema, psoriasis, and dermatitis fuels demand for hydrocortisone creams.

  • Infectious diseases: Growing MDR (multi-drug resistant) bacterial infections boosts usage of topical and systemic antibiotics like neomycin sulfate and polymyxin B sulfate.

  • Aging populations: Older adults have higher incidence of skin and systemic infections, supporting growth in both corticosteroids and antibiotics.

  • Regulatory approvals: New formulations and generics enhance market accessibility and lower prices.

Competitive Landscape

Major players operate across different regions. Example companies include:

  • Pfizer and Mylan: produce hydrocortisone creams and ointments.
  • GlaxoSmithKline and Bausch Health: markets for neomycin and polymyxin B combinations.
  • Presence of generic formulations increases market competition, effecting price reductions.

Regulatory Environment and Patent Status

  • Hydrocortisone: Several patents expired in early 2000s, leading to proliferation of generics.

  • Neomycin and Polymyxin B: No recent patent protections; availability of generics limits pricing power.

  • Regulatory trend: Increasing safety and efficacy requirements in the US and EU can delay new product launches, impacting market expansion.

Revenue Trajectory and Forecasts

Based on historical growth data and market drivers:

Year Estimated Market Size (USD Million) Growth Rate Source/Notes
2022 Hydrocortisone: 1,200; Antibiotics: 500 [1], [2]
2025 Hydrocortisone: 1,350; Antibiotics: 600 ~4% annually Projected internal estimates
2030 Hydrocortisone: 1,500; Antibiotics: 700 Slight acceleration Market trend analysis

Challenges and Risks

  • Regulatory hurdles: New product approvals, especially for combination drugs.
  • Pricing pressures: Increased generic competition lowers margins.
  • Resistance and safety concerns: Antibiotic resistance and steroid side effects influence prescribing patterns.
  • Patent expirations: Lead to market saturation and price declines.

Opportunities

  • New formulations: Topical gels, creams with improved stability.
  • Combination therapies: Multi-drug products targeting resistant bacteria.
  • Emerging markets: India, China, and Southeast Asia represent growth opportunities due to increasing healthcare access.

Key Takeaways

  • The global market for hydrocortisone and topical antibiotics is growing slowly but steadily, driven by rising infectious and inflammatory conditions.
  • Generics dominate revenue; patent expirations have increased competition but lowered entry barriers.
  • Regulatory and safety considerations may slow or alter the development of new formulations.
  • Emerging markets present new growth prospects, often at lower price points.
  • Pricing pressure and resistance concerns pose ongoing risks.

FAQs

1. What are the primary therapeutic uses of hydrocortisone?
Hydrocortisone treats inflammation, allergenic dermatitis, adrenal insufficiency, and some autoimmune conditions.

2. How does antibiotic resistance impact the market for neomycin sulfate and polymyxin B sulfate?
Resistance can reduce efficacy, leading to increased use of alternative or combination therapies, but overall anti-infective market growth faces pressure from resistance concerns.

3. What are the regulatory challenges for new formulations?
Approval processes demand evidence of safety, efficacy, and manufacturing quality, potentially delaying market entry.

4. How do patent expirations influence market dynamics?
Patent expirations increase generic competition, reducing prices and margins but expanding access.

5. Which regions offer the most growth potential?
Emerging markets like Asia, Latin America, and parts of Africa provide opportunities due to expanding healthcare infrastructure and rising disease prevalence.


Sources

[1] MarketsandMarkets, "Pharmaceuticals Market by Type," 2022
[2] GlobalData, "Topical Antibiotics Market Reports," 2022

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