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Last Updated: January 30, 2026

DEXAMETHASONE SODIUM PHOSPHATE - Generic Drug Details


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What are the generic sources for dexamethasone sodium phosphate and what is the scope of patent protection?

Dexamethasone sodium phosphate is the generic ingredient in thirteen branded drugs marketed by Ucb Inc, Merck, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Amneal, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland, Hikma, Intl Medication, Luitpold, Lyphomed, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, Watson Labs, Wyeth Ayerst, Aspen Global Inc, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz, and Alcon Pharms Ltd, and is included in fifty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for dexamethasone sodium phosphate. Twenty-four suppliers are listed for this compound.

Summary for DEXAMETHASONE SODIUM PHOSPHATE
US Patents:0
Tradenames:13
Applicants:31
NDAs:59
Drug Master File Entries: 11
Finished Product Suppliers / Packagers: 24
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 72
Patent Applications: 7,703
What excipients (inactive ingredients) are in DEXAMETHASONE SODIUM PHOSPHATE?DEXAMETHASONE SODIUM PHOSPHATE excipients list
DailyMed Link:DEXAMETHASONE SODIUM PHOSPHATE at DailyMed
Recent Clinical Trials for DEXAMETHASONE SODIUM PHOSPHATE

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

SponsorPhase
Cairo UniversityEARLY_PHASE1
Ain Shams UniversityPHASE1
Quince Therapeutics S.p.A.PHASE3

See all DEXAMETHASONE SODIUM PHOSPHATE clinical trials

Pharmacology for DEXAMETHASONE SODIUM PHOSPHATE
Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE SODIUM PHOSPHATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A06AD Osmotically acting laxatives
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
A06AG Enemas
A06A DRUGS FOR CONSTIPATION
A06 DRUGS FOR CONSTIPATION
A Alimentary tract and metabolism
B05XA Electrolyte solutions
B05X I.V. SOLUTION ADDITIVES
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
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE 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
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
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
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs
V03AG Drugs for treatment of hypercalcemia
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various

US Patents and Regulatory Information for DEXAMETHASONE SODIUM PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 203129-001 Sep 30, 2015 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 211451-001 Aug 1, 2023 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 084493-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 Dexamethasone Sodium Phosphate

Last updated: January 9, 2026

Executive Summary

Dexamethasone Sodium Phosphate (DSP), a potent corticosteroid used primarily for its anti-inflammatory and immunosuppressant properties, has experienced fluctuating market dynamics influenced by global healthcare trends, regulatory actions, and emerging therapeutic areas. Forecasts suggest steady growth driven by increasing adoption in COVID-19 management, autoimmune disorders, and oncology, alongside a robust pipeline and expanding generic availability. This report evaluates DSP's current market landscape, key drivers, challenges, and financial trajectories, providing valuable insights for stakeholders across the pharmaceutical sector.


What Is Dexamethasone Sodium Phosphate?

Chemical and Pharmacological Profile:

Parameter Details
CAS Number 3734-93-6
Drug Class Corticosteroid (Glucocorticoid)
Formulation Injectable (IM, IV), oral (sublingual)
Mechanism of Action Suppresses inflammation and immune response via glucocorticoid receptor activation
Therapeutic Uses Allergic reactions, inflammatory diseases, cerebral edema, COVID-19 (as per WHO guidance)

Market-wide Usage: DSP is employed across diverse indications, with notable recent prominence in COVID-19 as an evidence-backed treatment shown to reduce mortality among severely ill patients.


What Are the Key Market Drivers?

1. Increased Use in COVID-19 Treatment

  • Regulatory Endorsements: WHO’s 2020 recommendation for dexamethasone in severe COVID-19 cases significantly accelerated demand.
  • Market Impact: Sales surged globally during 2020–2021, with estimates indicating a 30% CAGR in specific markets post-pandemic onset [1].

2. Growing Incidence of Autoimmune and Inflammatory Conditions

  • Autoimmune Diseases: Rising prevalence of rheumatoid arthritis, lupus, and inflammatory bowel disease fuels demand.
  • Chronic Conditions: Increasing aging populations contribute to higher corticosteroid prescriptions worldwide.

3. Expansion of Generic Market & Infrastructure

  • Patent Expirations: With key patents expiring in the mid-2010s, generics offer cost-effective alternatives, broadening access.
  • Manufacturing Capabilities: Ongoing capacity expansion supports global supply chain demands.

4. Emerging Therapeutic Areas

  • Oncology & Neuroinflammation: Research indicates potential roles in brain tumor management and neuroinflammatory disorders.

What Are the Market Challenges?

1. Side Effect Profile and Regulatory Scrutiny

  • Adverse Effects: Long-term corticosteroid use linked to osteoporosis, hyperglycemia, and immunosuppression curtail some applications.
  • Regulatory Restrictions: Some markets enforce strict guidelines to prevent misuse.

2. Competition with Alternative Therapies

  • Biologics & Biosimilars: Increasing competition from targeted therapies limits DSP’s market share in certain indications.
  • Cost Considerations: Despite generics, pricing pressures persist, especially in low-income regions.

3. Supply Chain & Quality Control Issues

  • Raw Material Shortages: COVID-19 disruptions exposed vulnerabilities, impacting consistent supply.
  • Regulatory Compliance: Stringent manufacturing standards require continual investments.

What Is the Current Market Size and Forecast?

Global Market Size (2022):

Region Estimated Market Size (USD Million) Market Share Key Drivers
North America 1,200 40% COVID-19, oncology, autoimmune diseases
Europe 800 27% Regulatory approvals, aging population
Asia-Pacific 700 23% Rising prevalence of chronic diseases, manufacturing hub
Rest of World 300 10% Cost-sensitive markets, emerging healthcare infrastructure

Forecast (2023–2028):

Year Expected CAGR Notes
2023 8% Post-pandemic stabilization
2024–2028 6–9% Driven by growth in emerging markets and expanding indications

Note: CAGR projections adjusted for pandemic residuals, regulatory shifts, and patent landscape changes.


What Are the Major Market Participants?

Company Key Products Market Share Strategic Focus
Sanofi Dermovate (topical), Dexsol (injectable) ~20% Broad corticosteroid portfolio
Sandoz (Novartis) Generic DSP ~15% Cost leadership in generics
Teva Dexamethasone formulations ~10% Expand generics in emerging markets
Others Various regional players Remaining Niche formulations, biosimilars

How Is Pricing Evolving in the DSP Market?

Factors Impacting Pricing Trends & Insights
Patent Status Price drops post-patent expiry (~2015–2018)
Market Competition Entry of generics reduces average prices by 30–50%
Regulatory Environment Stringent post-approval quality standards influence costs
Regional Variations Prices lower in Asia-Pacific (<USD 0.50 per vial) compared to North America (~USD 1.50)

What Are The Regulatory and Policy Trends?

  • WHO Guidelines: COVID-19 Treatment Guidelines endorse DSP, amplifying global usage.
  • FDA & EMA: Approvals for both branded and generic formulations emphasize quality control.
  • Emerging Policies: Some countries implement restrictions on corticosteroid use to prevent misuse and adverse effects, impacting consumption patterns.

Comparison with Alternative Treatments

Aspect Dexamethasone Sodium Phosphate Hydrocortisone Methylprednisolone Prednisone
Potency High Moderate High Moderate
Administration IV, IM, oral Oral, IV IV, oral Oral
Uses COVID-19, autoimmune Addison's, allergic reactions Allergic, autoimmune Allergic, inflammation
Side Effects Similar across steroids; long-term risks Similar Similar Similar

Note: Dexamethasone’s longer half-life and higher potency make it suitable for specific indications but also increase risks of side effects.


What Is the Financial Trajectory?

Revenue Projections (2023–2028):

Year Estimated Global Revenue (USD Million) Notes
2023 2,300 Stabilization post-pandemic high
2024 2,450 Growth driven by ongoing COVID-19 demand
2025 2,600 Broadened indications, market expansion
2026 2,750 Increased penetration in emerging economies
2027 2,900 Potential patent cliff effects absorbed
2028 3,100 Sustained growth with new formulations

Assumptions: Consistent supply chain performance, regulatory approvals for new indications, and stabilization of COVID-19 treatment mandates.

Profitability Considerations:

Cost Factors Impact on Profit Margins Strategies
Raw Material Costs Slightly rising with supply chain disruptions Diversify suppliers
Manufacturing Economies of scale reduce unit costs Capacity expansion investments
Marketing & Distribution Regional variances Tailored regional strategies

What Are the Comparative Insights and Future Outlook?

Aspect Current State Future Outlook
Market Size USD 2.3B globally (2023) USD 3.1B by 2028
Key Growth Areas COVID-19, auto-immune, oncology Emerging markets, biosimilars
Regulatory Environment Positive endorsement refined Increased oversight, potential restrictions
Competitive Landscape Dominated by generics Rise of biosimilars and niche therapies

Emerging Trends:

  • Integration with targeted therapies for combination treatments.
  • Development of sustained-release formulations.
  • Focus on biosimilars to reduce costs and increase accessibility.

Key Takeaways

  • Dominance of COVID-19: DSP's recent surge attributable to its inclusion in COVID-19 treatment protocols has established a new revenue baseline.
  • Pipeline and Expansion Opportunities: Growing adoption in oncology, autoimmune, and neuroinflammatory diseases suggest sustained future growth.
  • Market Competition: Generics dominate pricing and volume, but biosimilars and niche formulations pose future competitive challenges.
  • Regulatory Landscape: Ensures quality but could impose restrictions, affecting supply and demand.
  • Regional Dynamics: Asia-Pacific leads in growth potential owing to demographic trends and manufacturing capabilities.

FAQs

1. How does Dexamethasone Sodium Phosphate compare with other corticosteroids in efficacy?

DSP is recognized for its high potency and long duration of action compared to alternatives like hydrocortisone. It is particularly effective in severe inflammation and COVID-19 management but carries higher risks of adverse effects with prolonged use.

2. What are the main regulatory hurdles for DSP manufacturers?

Manufacturers face rigorous quality standards from agencies like the FDA and EMA, including strict Good Manufacturing Practices (GMP). Recent policies also scrutinize corticosteroid misuse, influencing approval and supply protocols.

3. Will the patent landscape affect future market growth?

Dexamethasone itself is off-patent, which favors generics and biosimilars. However, patent protection of specific formulations or delivery mechanisms could influence competitiveness in niche segments.

4. What are the significant regional differences influencing DSP demand?

Demand is highest in North America and Europe due to higher healthcare spending and aging populations. Asia-Pacific, with rising chronic disease prevalence and manufacturing capacity, presents the fastest-growing market segment.

5. How might new therapeutic developments impact DSP's market?

Emerging targeted and biologic therapies may replace corticosteroids in some indications. However, DSP’s low cost and established efficacy ensure its continued relevance, particularly in resource-limited settings.


Sources

[1] WHO, "Guidelines for the Pharmacological Management of COVID-19," 2020.

[2] MarketWatch, "Dexamethasone Market Analysis," 2022.

[3] GlobalData, "Steroid Market Forecast," 2023.

[4] FDA Drug Approvals, "Dexamethasone Formulation Approvals," 2021.

[5] International Journal of Clinical Pharmacology, "Corticosteroids in Autoimmune Diseases," 2022.


This analysis provides a comprehensive overview of the current market landscape and future trajectory for Dexamethasone Sodium Phosphate, enabling stakeholders to strategize accordingly.

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