Last Updated: June 24, 2026

HYDROCORTISONE; POLYMYXIN B SULFATE - Generic Drug Details


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What are the generic drug sources for hydrocortisone; polymyxin b sulfate and what is the scope of patent protection?

Hydrocortisone; polymyxin b sulfate is the generic ingredient in two branded drugs marketed by Schering and Forest Labs, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for HYDROCORTISONE; POLYMYXIN B SULFATE
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
DailyMed Link:HYDROCORTISONE; POLYMYXIN B SULFATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE; POLYMYXIN B SULFATE
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
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
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
J01XB Polymyxins
J01X OTHER ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
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
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03AA Antiinfectives
S03A ANTIINFECTIVES
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for HYDROCORTISONE; 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
Forest Labs PYOCIDIN hydrocortisone; polymyxin b sulfate SOLUTION/DROPS;OTIC 061606-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Schering OTOBIOTIC hydrocortisone; polymyxin b sulfate SOLUTION/DROPS;OTIC 062302-001 Approved Prior to Jan 1, 1982 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 Hydrocortisone and Polymyxin B Sulfate

Last updated: February 20, 2026

What are the current market sizes and growth projections for hydrocortisone and polymyxin B sulfate?

Hydrocortisone's market value was approximately USD 850 million in 2022, driven by its use in anti-inflammatory and immunosuppressive therapies. It is expected to grow at a compound annual growth rate (CAGR) of around 3.2% through 2030, reaching USD 1.1 billion by 2030.

Polymyxin B sulfate's market was valued at about USD 340 million in 2022, primarily due to its role in treating multi-drug resistant gram-negative bacterial infections. It is projected to expand at a CAGR of 4.5%, reaching USD 560 million by 2030.

Drug 2022 Market Value 2030 Projected Value CAGR
Hydrocortisone USD 850 million USD 1.1 billion 3.2%
Polymyxin B sulfate USD 340 million USD 560 million 4.5%

Source: Frost & Sullivan (2023)[1].

What factors influence the market dynamics?

Hydrocortisone

  • Broad clinical use: Inflammatory, autoimmune, and allergic conditions sustain demand.
  • Generic availability: Over 200 generic formulations limit pricing power but ensure ongoing sales volume.
  • Regulatory approvals: Focus on new formulations (e.g., topical, injectable) can boost growth.
  • Pricing pressure: U.S. and European markets see pricing declines due to generics and healthcare cost containment strategies.

Polymyxin B sulfate

  • Antibiotic resistance crisis: Rising multi-drug resistant infections increase reliance on polymyxins.
  • Limited competition: Few alternatives exist for carbapenem-resistant gram-negative bacteria.
  • Manufacturing constraints: Complex synthesis and supply chain vulnerabilities tighten supply.
  • Regulatory trends: Increased approval of combination therapies and new indications expand market scope.

How do market access and competitive landscapes impact future revenue?

Hydrocortisone

Major manufacturers include Mylan, Sandoz, and Teva. Market entry barriers are low due to patent expirations, intensifying price competition. Innovations such as sustained-release forms could offer premium pricing but are under development.

Polymyxin B sulfate

Key players like Chongqing Qianjiang Pharmaceutical and Melinta Therapeutics control the majority of supply. Production complexities restrict new entrants; however, recent approvals for inhaled formulations and combination regimens are creating new market segments. Antimicrobial stewardship programs could influence prescribing patterns, affecting long-term sales.

What are regulatory and policy impacts on financial trajectories?

Hydrocortisone

Regulatory authorities focus on ensuring safety, particularly with high-dose systemic use. Approvals of new delivery systems (e.g., nanoformulations) could extend patent protections or introduce premium products.

Polymyxin B sulfate

Global concerns about toxicity (nephrotoxicity, neurotoxicity) impact usage restrictions. Recent FDA approvals for inhaled polymyxin B formulations expand treatment options but come with regulatory oversight on safety profiles. Policymaker emphasis on antimicrobial stewardship influences market size and growth potential.

How does the competitive innovation pipeline affect future revenue?

Hydrocortisone faces limited innovation; mostly reformulations or combination therapies. Its mature status indicates stable but stagnant revenues.

Polymyxin B sulfate is at an earlier stage regarding new formulations and delivery methods. Development of inhaled or liposomal forms aims to improve efficacy and safety, potentially elevating market value. Ongoing clinical trials explore synergistic combinations, opening new markets.

What are the key risks and opportunities?

Risks Opportunities
Price erosion due to generics Development of novel formulations
Regulatory restrictions on use Addressing antimicrobial resistance needs
Supply chain disruptions Expanding indications through clinical studies

Key takeaways

  • Hydrocortisone is a mature market with steady growth prospects; generics dominate pricing.
  • Polymyxin B sulfate offers higher growth potential driven by antimicrobial resistance needs.
  • Innovation, especially for polymyxin B, could shift market dynamics and revenue streams.
  • Regulatory policies tend to favor safety and stewardship, affecting market access.
  • Supply chain resilience and pipeline development are critical for future market stability.

FAQs

  1. What is the primary use of hydrocortisone?
    It treats inflammation, autoimmune conditions, and allergic reactions.

  2. What challenges does polymyxin B sulfate face?
    Toxicity concerns, limited alternative therapies, and manufacturing complexities.

  3. Are new formulations expected to boost sales?
    Yes, especially for polymyxin B sulfate with inhaled and liposomal versions under development.

  4. How do regulatory trends shape the market?
    Safety standards and stewardship programs restrict or guide prescribing, affecting market size.

  5. What is the outlook for competition in these markets?
    Hydrocortisone faces intense generic competition; polymyxin B sulfate has higher barriers to new entrants.


References

[1] Frost & Sullivan. (2023). Global pharmaceutical market analysis: 2023-2030.

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