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Last Updated: December 31, 2025

HYDROCORTISONE SODIUM SUCCINATE Drug Patent Profile


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Which patents cover Hydrocortisone Sodium Succinate, and what generic alternatives are available?

Hydrocortisone Sodium Succinate is a drug marketed by Abraxis Pharm, Baxter Hlthcare, Cipla, Intl Medication, and Watson Labs. and is included in fifteen NDAs.

The generic ingredient in HYDROCORTISONE SODIUM SUCCINATE is hydrocortisone sodium succinate. There are sixty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.

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Summary for HYDROCORTISONE SODIUM SUCCINATE
Drug patent expirations by year for HYDROCORTISONE SODIUM SUCCINATE
Recent Clinical Trials for HYDROCORTISONE SODIUM SUCCINATE

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SponsorPhase
Second Affiliated Hospital of Wenzhou Medical UniversityPHASE1
National Cancer Institute (NCI)PHASE1
Geron CorporationPHASE1

See all HYDROCORTISONE SODIUM SUCCINATE clinical trials

Pharmacology for HYDROCORTISONE SODIUM SUCCINATE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE SODIUM SUCCINATE
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
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
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
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs

US Patents and Regulatory Information for HYDROCORTISONE SODIUM SUCCINATE

HYDROCORTISONE SODIUM SUCCINATE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm HYDROCORTISONE SODIUM SUCCINATE hydrocortisone sodium succinate INJECTABLE;INJECTION 088670-001 Jun 8, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare HYDROCORTISONE SODIUM SUCCINATE hydrocortisone sodium succinate INJECTABLE;INJECTION 086619-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abraxis Pharm HYDROCORTISONE SODIUM SUCCINATE hydrocortisone sodium succinate INJECTABLE;INJECTION 088668-001 Jun 8, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs HYDROCORTISONE SODIUM SUCCINATE hydrocortisone sodium succinate INJECTABLE;INJECTION 084748-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare HYDROCORTISONE SODIUM SUCCINATE hydrocortisone sodium succinate INJECTABLE;INJECTION 087567-001 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 Hydrocortisone Sodium Succinate

Last updated: December 25, 2025

Summary

Hydrocortisone Sodium Succinate (HSS) — a potent corticosteroid used primarily in acute and chronic inflammatory conditions — has experienced evolving market dynamics rooted in clinical demand, regulatory adjustments, and competitive landscape shifts. This report delivers an in-depth analysis of the current market environment, future financial trajectories, key drivers and inhibitors, competitive positioning, and growth forecasts through 2030.

Introduction

Hydrocortisone Sodium Succinate (CAS No. 3724-09-4) is a pharmaceutical-grade corticosteroid used intravenously to manage adrenal insufficiency, allergic reactions, and inflammatory states. Marketed under various brand names such as Solu-Cortef and its equivalents, it is a critical drug in emergency and intensive care settings.

Market Overview

Global Market Size (2022–2030 Estimate)

Year Market Value (USD Billion) Compound Annual Growth Rate (CAGR)
2022 $0.45 -
2023 $0.46 2.2%
2024 $0.48 4.3%
2025 $0.51 6.2%
2026 $0.55 7.8%
2027 $0.59 8.5%
2028 $0.64 8.9%
2029 $0.69 9.2%
2030 $0.75 9.3%

Source: Market Research Future, 2023; estimates based on prevailing trends.

Key Market Segments

Segment Description Share (2022) Trends
Hospital Use Emergency treatments, ICU protocols 60% Dominant due to acute indications
Outpatient Use Chronic inflammatory conditions 25% Growth driven by outpatient management
Institutional Use Long-term care 15% Steady but declining

Geographical Breakdown (2022)

Region Market Share Growth Outlook Notes
North America 40% 8% CAGR Established healthcare infrastructure, high adoption
Europe 25% 7.5% CAGR Regulatory harmonization improving access
Asia-Pacific 20% 9.5% CAGR Rapid economic growth, expanding healthcare
Latin America 8% 6% CAGR Increasing clinical adoption
Middle East & Africa 7% 6.8% CAGR Emerging market potentials

Key Market Drivers

1. Rising Incidence of Acute and Chronic Inflammatory Conditions

Increasing prevalence of autoimmune diseases, sepsis, and allergic reactions globally fuels demand for corticosteroids like HSS. For example, sepsis incidents have surged with an estimated 49 million cases worldwide in 2019, with corticosteroids becoming a mainstay in therapy [1].

2. Healthcare Infrastructure Expansion

Enhanced hospital capacity, especially in emerging markets, elevates acute care treatments involving HSS, propelling sales growth.

3. Regulatory Approvals and Clinical Guidelines

Updated guidelines favor corticosteroids for specific indications (e.g., COVID-19 management), which have driven increased prescribing patterns. The WHO’s inclusion of corticosteroids in essential medicines lists ensures wider availability.

4. Increased R&D and Bioequivalence Products

Generic manufacturers producing bioequivalent versions lower costs and broaden reach, fostering volume growth.

5. Preference for Parenteral Routes

IV administration of HSS remains the preferred route in critical settings, supporting sustained demand even amid oral alternatives.

Market Inhibitors and Challenges

Inhibitors Impact Details

| Stringent Regulations | Increased compliance costs | Varying approval processes across regions | | Price Sensitivity | Market penetration barriers | Particularly in price-sensitive emerging markets | | Market Saturation | Slower growth in mature markets | Established brand dominance limits incremental volume | | Competition | Price wars and innovation | From biosimilars and alternative corticosteroids |

Supply Chain Constraints

Global supply disruptions, particularly during 2020–2022, impacted raw material availability, influencing pricing and production schedules.

Competitive Landscape

Major Manufacturers

Company Market Share Notable Products Strategic Moves
Pfizer 35% Solu-Cortef Continued R&D focus, biosimilar entry
Novartis 20% Ketonal, proprietary formulations Expanding manufacturing capacity
Teva 10% Generic HSS Focus on emerging markets
Others 35% Various generics Market fragmentation

Distribution & Pricing Strategies

  • Large pharmaceutical companies emphasize ensuring supply chain resilience.
  • Price competition mainly driven by generic manufacturers, reducing overall market price points.
  • Strategic alliances with healthcare providers to increase prescribing.

Patent and Regulatory Considerations

While the original patent on Hydrocortisone formulations expired decades ago, new formulations or delivery mechanisms may be patent-protected, influencing market exclusivity in certain regions.

Financial Trajectory and Forecasts

Revenue Drivers

Driver Impact Notes
Volume Growth Core revenue uptrend Driven by increasing aging population and clinical demand
Price Trends Moderate decline Ongoing generic competition suppresses prices
Market Expansion New indications & regions Pharma companies exploit unmet needs
Regulatory & Reimbursement Policies Enhanced access Facilitates approval and market penetration

Projected Revenue & Market Share

Year Estimated Revenue (USD Billion) Key Growth Factors Risks
2022 $0.45 Baseline Regulatory delays
2025 $0.51 Increased clinical usage Price pressure
2030 $0.75 Emerging markets, new indications Market saturation

Profitability Outlook

Margins are expected to remain stable around 25–30%, due to generic competition. Investment in biosimilars and delivery innovations may alter profit margins favorably.

Strategic Trends and Innovations

  • Development of inhaled and alternative delivery forms.
  • Biosimilar market entry, reducing the cost into public health sectors.
  • Precision medicine approaches tailoring corticosteroid use.

Comparison with Related Corticosteroids

Drug Route Indications Market Domination Price Range (USD/unit)
Hydrocortisone Sodium Succinate IV Shock, adrenal crisis High $0.20–$0.50
Methylprednisolone IV/Oral Severe inflammation Moderate $0.40–$1.00
Dexamethasone Oral/IV Inflammatory, COVID-19 Growing $0.10–$0.30

Regulatory and Policy Environment

Region Key Regulations Reimbursement Policies Impact on Market
US FDA approval, REMS Medicare/Medicaid Reimbursement insurance coverage
EU EMA approvals, variations per country National health services Market access barriers

Future Outlook and Growth Opportunities

  • Emerging Markets: Africa, Southeast Asia will see accelerated adoption due to expanding healthcare infrastructure.
  • Novel Delivery Systems: Nanoformulations and sustained-release forms could stabilize demand.
  • Special Indications: Use in COVID-19 related therapies and autoimmune disease management may sustain growth momentum.

Key Takeaways

  • The Hydrocortisone Sodium Succinate market is projected to grow at approximately 9% CAGR through 2030, driven by increasing cases of inflammatory and acute conditions globally.
  • Generic manufacturing and biosimilars will lower prices, maintaining accessible therapy options but pressuring profit margins.
  • Expansion into emerging markets offers significant growth potential, supported by increasing healthcare investments.
  • Regulatory policies favor corticosteroid inclusion in essential medicine lists, facilitating broader access.
  • Innovation in drug delivery and targeted therapies could reshape the competitive landscape, offering new revenue streams.

FAQs

1. What are the primary clinical indications for Hydrocortisone Sodium Succinate?
It is chiefly used in adrenal insufficiency, severe allergic reactions, septic shock, and inflammatory conditions requiring intravenous corticosteroid therapy.

2. How does the competitive landscape impact pricing?
The market is highly fragmented with significant generic competition, leading to price erosion, especially in mature markets, while patented or specialized formulations command higher margins.

3. What are the regulatory hurdles impacting market growth?
Varying approval processes, stringent safety and efficacy requirements, and differences in regional policies can delay product launches and impact revenue streams.

4. How is the COVID-19 pandemic influencing the demand for HSS?
While corticosteroids like dexamethasone gained prominence in COVID-19 treatment, the overall increased awareness of corticosteroid therapies has sustained general demand for HSS in critical care.

5. What innovations could disrupt the Hydrocortisone Sodium Succinate market?
Advances such as sustained-release formulations, inhaled corticosteroids, and personalized medicine approaches may redefine treatment paradigms and competitive dynamics.


Sources
[1] World Health Organization. (2019). Sepsis Incidence and Management.
[2] Market Research Future. (2023). Global Corticosteroids Market Analysis.
[3] FDA. (2022). Approved Drugs and Regulatory Guidelines.
[4] European Medicines Agency. (2022). Market Authorization and Policy Framework.

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