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Last Updated: December 22, 2024

METHYLPREDNISOLONE SODIUM SUCCINATE - Generic Drug Details


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What are the generic sources for methylprednisolone sodium succinate and what is the scope of freedom to operate?

Methylprednisolone sodium succinate is the generic ingredient in four branded drugs marketed by Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Amneal, Bedford Labs, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, Watson Labs, and Pharmacia And Upjohn, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for methylprednisolone sodium succinate. Fourteen suppliers are listed for this compound.

Summary for METHYLPREDNISOLONE SODIUM SUCCINATE
US Patents:0
Tradenames:4
Applicants:17
NDAs:49
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 14
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 34
Patent Applications: 6,657
What excipients (inactive ingredients) are in METHYLPREDNISOLONE SODIUM SUCCINATE?METHYLPREDNISOLONE SODIUM SUCCINATE excipients list
DailyMed Link:METHYLPREDNISOLONE SODIUM SUCCINATE at DailyMed
Recent Clinical Trials for METHYLPREDNISOLONE SODIUM SUCCINATE

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

SponsorPhase
Medisch Spectrum TwentePhase 3
HagaZiekenhuisPhase 3
Leiden University Medical CenterPhase 3

See all METHYLPREDNISOLONE SODIUM SUCCINATE clinical trials

Pharmacology for METHYLPREDNISOLONE SODIUM SUCCINATE
Anatomical Therapeutic Chemical (ATC) Classes for METHYLPREDNISOLONE 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
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
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
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

US Patents and Regulatory Information for METHYLPREDNISOLONE SODIUM SUCCINATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elkins Sinn METHYLPREDNISOLONE methylprednisolone sodium succinate INJECTABLE;INJECTION 086906-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn SOLU-MEDROL methylprednisolone sodium succinate INJECTABLE;INJECTION 011856-006 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Tianjin Kingyork METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 212396-002 Apr 20, 2021 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 087030-001 Jul 22, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

METHYLPREDNISOLONE SODIUM SUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Methylprednisolone Sodium Succinate

Introduction

Methylprednisolone sodium succinate, a potent anti-inflammatory steroid, has been a cornerstone in the treatment of various inflammatory and autoimmune diseases. The market for this drug has experienced significant growth and is poised for continued expansion. Here, we delve into the market dynamics, financial trajectory, and key factors influencing the methylprednisolone sodium succinate market.

Market Growth and Projections

The methylprednisolone sodium succinate market has encountered rapid and substantial growth in recent years. Projections indicate a continued significant expansion from 2023 to 2031, driven by the increasing prevalence of inflammatory and autoimmune diseases globally[1][3][5].

Market Segmentation

The market is segmented based on type (oral and infusion), application (hospital and clinic), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and identifying opportunities for growth.

Type Segmentation

  • Infusion Type: This segment dominates the market due to the rapid onset of action and effectiveness of methylprednisolone sodium succinate injections, particularly in emergency and critical care settings[5].
  • Oral Type: Although less prominent, oral formulations are still used in certain clinical scenarios where intravenous or intramuscular administration is not feasible.

Application Segmentation

  • Hospital Use: Hospitals are the primary users of methylprednisolone sodium succinate, given its widespread application in treating severe allergic conditions, autoimmune disorders, and other inflammatory diseases[1][5].
  • Clinic Use: Clinics also utilize this drug, especially for outpatient treatments and follow-up care.

Geographical Segmentation

  • North America: This region remains a dominant force in the global market, driven by high healthcare expenditures, advanced medical infrastructure, and a significant burden of inflammatory and autoimmune diseases[5].
  • Europe and Asia-Pacific: These regions also exhibit strong market presence due to similar factors, including high healthcare spending and a growing incidence of chronic inflammatory conditions.
  • Latin America and Middle East & Africa: These regions present emerging opportunities, with a rising burden of chronic inflammatory conditions and improving healthcare infrastructures[5].

Market Drivers

Several factors drive the growth of the methylprednisolone sodium succinate market:

Increasing Prevalence of Inflammatory and Autoimmune Diseases

The global rise in conditions such as rheumatoid arthritis, inflammatory bowel disease, and allergic reactions necessitates effective anti-inflammatory treatments, thereby driving the demand for methylprednisolone sodium succinate[5].

Rapid Onset of Action

The drug's ability to provide rapid relief makes it a preferred choice in acute settings where immediate control of symptoms is critical for patient outcomes[2][5].

Expanding Applications

Methylprednisolone sodium succinate is increasingly used in oncology, particularly in palliative care and cancer-related inflammation, and in organ transplantation, further enhancing its market demand[5].

Market Restraints

Despite the growth, the market faces several restraints:

Competition from Other Corticosteroid Formulations

The presence of other corticosteroid formulations and treatments poses a competitive challenge to methylprednisolone sodium succinate[5].

Regulatory and Pricing Challenges

Stringent regulatory environments, especially in regions like North America, and challenges related to pricing and reimbursement can hinder market growth[5].

Side Effects and Contraindications

The drug has contraindications, such as systemic fungal infections and certain conditions like sepsis syndrome and septic shock, which can limit its use in specific patient populations[2].

Competitive Analysis

The methylprednisolone sodium succinate market is highly competitive, with a mix of global pharmaceutical giants, regional players, and generic manufacturers. Companies compete through innovation, pricing strategies, and geographical expansion. Collaborations between pharmaceutical companies, healthcare providers, and research institutions are crucial for fostering innovation and addressing unmet medical needs[5].

Financial Trajectory

The financial trajectory of the methylprednisolone sodium succinate market is promising, with sustained growth expected due to ongoing advancements in pharmaceutical research and expanding clinical indications. Here are some key financial aspects:

Revenue Projections

The market size is projected to increase significantly from 2023 to 2031, measured in USD million, across various segments. The revenue growth is driven by the increasing demand for effective anti-inflammatory treatments and the drug's versatility in managing a wide range of conditions[1][3][5].

Regional Financial Dynamics

North America, Europe, and Asia-Pacific regions are expected to contribute substantially to the revenue due to their advanced healthcare infrastructures and high healthcare expenditures. Emerging markets in Latin America and the Middle East & Africa also present significant financial opportunities as healthcare investments increase in these regions[5].

Investment and Research

Pharmaceutical companies are investing heavily in research and development to improve the safety profile and patient compliance of methylprednisolone sodium succinate injections. Innovations in drug delivery systems, such as sustained-release formulations and combination therapies, are expected to enhance the market's financial performance[5].

Future Outlook

The future outlook for the methylprednisolone sodium succinate market is promising, driven by several factors:

Expanding Clinical Indications

The drug's applications are expanding into new areas such as oncology and organ transplantation, which will continue to drive market growth[5].

Regulatory Reforms

Regulatory reforms and healthcare policies aimed at improving patient access to essential medications are anticipated to support market expansion[5].

Collaborations and Innovations

Collaborations between pharmaceutical companies, healthcare providers, and research institutions will foster innovation and address unmet medical needs in inflammatory and autoimmune diseases, further enhancing the market's financial trajectory[5].

Key Takeaways

  • Growing Demand: Increasing prevalence of inflammatory and autoimmune diseases drives market demand.
  • Rapid Onset of Action: The drug's rapid effectiveness in acute settings is a key market driver.
  • Expanding Applications: Use in oncology, organ transplantation, and other areas enhances market demand.
  • Competitive Market: The market is highly competitive with global and regional players.
  • Financial Growth: Sustained revenue growth is expected due to advancements in pharmaceutical research and expanding clinical indications.

FAQs

What are the primary drivers of the methylprednisolone sodium succinate market?

The primary drivers include the increasing prevalence of inflammatory and autoimmune diseases, the rapid onset of action of the drug, and its expanding applications in areas like oncology and organ transplantation.

Which regions dominate the methylprednisolone sodium succinate market?

North America, Europe, and Asia-Pacific regions dominate the market due to their advanced healthcare infrastructures and high healthcare expenditures.

What are the main restraints facing the methylprednisolone sodium succinate market?

The main restraints include competition from other corticosteroid formulations, regulatory and pricing challenges, and side effects and contraindications associated with the drug.

How is the competitive landscape of the methylprednisolone sodium succinate market?

The market is highly competitive with a mix of global pharmaceutical giants, regional players, and generic manufacturers competing through innovation, pricing strategies, and geographical expansion.

What is the future outlook for the methylprednisolone sodium succinate market?

The future outlook is promising, driven by expanding clinical indications, regulatory reforms, and collaborations between pharmaceutical companies, healthcare providers, and research institutions.

Sources

  1. Market Research Intellect: Global Methylprednisolone Sodium Succinate Market Size, Trends ...
  2. FDA: SOLU-MEDROL (methylprednisolone sodium succinate for injection) Label.
  3. Central News Channel Nebraska: 2024 Methylprednisolone Sodium Succinate Market Report Analysis ...
  4. Market Research Intellect: Taille, tendances et projections du marché mondial des ballons ...
  5. Data Horizon Research: Methylprednisolone Sodium Succinate For Injection Market Size ...

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