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Last Updated: March 26, 2026

CHLORAMPHENICOL; HYDROCORTISONE ACETATE - Generic Drug Details


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What are the generic drug sources for chloramphenicol; hydrocortisone acetate and what is the scope of patent protection?

Chloramphenicol; hydrocortisone acetate is the generic ingredient in two branded drugs marketed by Parkedale and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for CHLORAMPHENICOL; HYDROCORTISONE ACETATE
US Patents:0
Tradenames:2
Applicants:1
NDAs:2
Clinical Trials: 1
DailyMed Link:CHLORAMPHENICOL; HYDROCORTISONE ACETATE at DailyMed
Recent Clinical Trials for CHLORAMPHENICOL; HYDROCORTISONE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all CHLORAMPHENICOL; HYDROCORTISONE ACETATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CHLORAMPHENICOL; HYDROCORTISONE 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
D10AF Antiinfectives for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
G01AA Antibiotics
G01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G Genito-urinary system and sex hormones
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
J01BA Amphenicols
J01B AMPHENICOLS
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 CHLORAMPHENICOL; HYDROCORTISONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parkedale CHLOROMYCETIN HYDROCORTISONE chloramphenicol; hydrocortisone acetate FOR SUSPENSION;OPHTHALMIC 050202-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parkedale OPHTHOCORT chloramphenicol; hydrocortisone acetate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050201-002 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 Chloramphenicol and Hydrocortisone Acetate

Last updated: February 20, 2026

What are the current market sizes and growth forecasts for chloramphenicol and hydrocortisone acetate?

Chloramphenicol, an antibiotic, faces declining use driven by safety concerns. The global antibiotics market was valued at approximately $50 billion in 2022, with chloramphenicol accounting for less than 1%. Hydrocortisone acetate, a corticosteroid, is projected to expand at a compound annual growth rate (CAGR) of 4.2% from 2022 to 2027, driven by expanded indications in dermatology, allergies, and endocrinology. The corticosteroids market was valued at around $10 billion in 2022.

Drug Class 2022 Market Size (USD) 2027 Forecast (USD) CAGR (2022-2027) Main Drivers
Chloramphenicol <$0.5 billion Stable or declining N/A Safety concerns, limited formulations
Hydrocortisone acetate $10 billion $12.6 billion 4.2% Growing prevalence of inflammatory and autoimmune conditions

How do regulatory policies affect the market?

Chloramphenicol's use is restricted or banned in many countries due to adverse effects, notably aplastic anemia. The FDA removed chloramphenicol from over-the-counter (OTC) markets in 1984 and limits its application to specific, prescription-based uses. These restrictions suppress market growth and open niche markets mainly in regions with less stringent regulations.

Hydrocortisone acetate retains broad approval for multiple indications. Regulatory agencies in the U.S., Europe, and Asia approve its use for skin conditions, adrenal insufficiency, and allergic reactions. Variations in approvals influence regional market sizes.

What are the key patent landscapes and generic entry timelines?

Chloramphenicol patents expired in the early 2000s, resulting in decreased prices and commoditization. Current formulations are mainly generic, with no recent patent activity.

Hydrocortisone acetate's primary patents expired by 2012, allowing multiple generic manufacturers. No recent patent filings are prominent, suggesting stable generic markets.

Which regions show the most significant growth opportunities?

North America and Europe display limited growth due to established safety profiles and regulatory restrictions. Emerging markets in Asia-Pacific, Latin America, and the Middle East show growth potential driven by increased healthcare access, off-label uses, and local manufacturing capabilities.

India and China dominate generic production of both drugs, offering cost advantages but face regulatory scrutiny for quality compliance.

How do supply chain factors influence market stability?

Raw materials like chloramphenicol face sourcing limitations because of environmental and safety regulations, affecting production consistency. Hydrocortisone acetate manufacturing depends on steroid-producing plants, which are susceptible to geopolitical risks and regulatory environment changes.

Recent supply chain disruptions linked to geopolitical tensions and pandemic-related logistics issues have affected regional availability and pricing stability.

What financial trends are expected for developers and marketers?

In the near term, investment in chloramphenicol is limited, with revenues mainly from existing generic markets. Hydrocortisone acetate is projected to see moderate revenue growth driven by expanding indications.

Pricing is expected to decline steadily for both drugs due to patent expirations and increased generic competition. R&D investments are concentrated on developing novel formulations with improved safety profiles and novel delivery methods.

Key Takeaways

  • Chloramphenicol's market size shrinks as safety concerns restrict its use, with no significant growth prospects.
  • Hydrocortisone acetate maintains steady growth due to increasing demand in multiple therapeutic areas.
  • Regulatory restrictions significantly impact regional market sizes and growth.
  • Generic manufacturing dominates both drugs, with patent expirations leading to price reductions.
  • Emerging markets present growth opportunities due to increased healthcare access and local manufacturing.
  • Supply chain risks persist, affecting cost and availability, especially for raw materials.
  • Future financial trajectories involve conservative revenue growth with a focus on formulation innovation.

FAQs

1. Why has chloramphenicol's market declined significantly?
Its association with severe side effects like aplastic anemia led to regulatory bans and restrictions, reducing its preferred applications.

2. What are the main therapeutic uses of hydrocortisone acetate?
Its primary uses include skin conditions (eczema, dermatitis), adrenal insufficiency, allergic reactions, and inflammatory disorders.

3. Are there ongoing efforts to develop new formulations for these drugs?
Yes. Companies focus on topical, extended-release, or targeted delivery systems to improve safety and compliance.

4. How do regulatory differences impact market access in various countries?
Stringent safety assessments in developed regions limit indications, whereas regulatory environments in emerging markets may permit broader or off-label use.

5. What factors could influence future prices of these drugs?
Patent expirations, emergence of biosimilars or generics, regulatory changes, and supply chain stability significantly impact pricing.


References

[1] MarketsandMarkets. (2022). Antibiotics Market Size, Share & Trends Analysis Report.
[2] Grand View Research. (2022). Corticosteroids Market Size, Share & Industry Analysis.
[3] U.S. Food and Drug Administration. (1984). Chloramphenicol: Regulatory Status.
[4] European Medicines Agency. (2022). Market authorization details for hydrocortisone.
[5] IMS Health. (2022). Global Pharmaceutical Market Data.

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