Methylprednisolone - Generic Drug Details

What are the generic sources for methylprednisolone and what is the scope of patent protection?

Methylprednisolone is the generic ingredient in eleven branded drugs marketed by Pfizer, Amneal, Chartwell Rx, Duramed Pharms Barr, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Ph Health, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Pharmacia And Upjohn, Bel Mar, Epic Pharma Llc, Eugia Pharma, Hikma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in ninety-three NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for methylprednisolone. Twenty-eight suppliers are listed for this compound.

Summary for methylprednisolone

US Patents:	0
Tradenames:	11
Applicants:	35
NDAs:	93
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	902
Drug Prices:	Drug price trends for methylprednisolone
Drug Sales Revenues:	Drug sales revenues for methylprednisolone
What excipients (inactive ingredients) are in methylprednisolone?	methylprednisolone excipients list
DailyMed Link:	methylprednisolone at DailyMed

See drug prices for methylprednisolone

See drug sales revenues for methylprednisolone

Recent Clinical Trials for methylprednisolone

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

Sponsor	Phase
Children's Oncology Group	PHASE2
Vanderbilt University Medical Center	PHASE4
University of California, San Francisco	PHASE2

See all methylprednisolone clinical trials

Pharmacology for methylprednisolone

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for methylprednisolone

Anti-Inflammatory Agents

Antiemetics

Glucocorticoids

Neuroprotective Agents

Anatomical Therapeutic Chemical (ATC) Classes for methylprednisolone

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
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

US Patents and Regulatory Information for methylprednisolone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	MEDROL ACETATE	methylprednisolone acetate	OINTMENT;TOPICAL	012421-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ph Health	METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	040183-001	Dec 22, 1998	AB	RX	No	No
Organon Usa Inc	METHYLPREDNISOLONE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	087535-002	Jun 25, 1982		DISCN	No	No
Bedford Labs	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040709-002	Feb 21, 2007		DISCN	No	No

Market Dynamics and Financial Trajectory for Methylprednisolone

Last updated: December 25, 2025

Executive Summary

Methylprednisolone, a synthetic glucocorticoid with potent anti-inflammatory and immunosuppressive properties, has been a mainstay in the treatment of various inflammatory, allergic, autoimmune, and ophthalmic conditions since its market introduction. Its global market size was valued at approximately USD 950 million in 2022, with a compound annual growth rate (CAGR) of around 4.2% forecasted through 2030. This growth trajectory is driven chiefly by increasing prevalence of chronic inflammatory diseases, expanding indications, and evolving therapeutic guidelines favoring corticosteroid use.

The market landscape is highly competitive, dominated by key pharmaceutical players such as Pfizer, Teva, Mylan, Sandoz, and Sun Pharmaceutical. Patent expirations and the proliferation of generic versions significantly influence pricing strategies, overall revenues, and market penetration.

This analysis explores the factors shaping the current and future market dynamics of methylprednisolone, including regulatory policies, technological advancements, competitive landscape, and socioeconomic influences.

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What Are the Key Market Drivers for Methylprednisolone?

1. Rising Prevalence of Chronic Inflammatory and Autoimmune Disorders

• States such as rheumatoid arthritis, multiple sclerosis, asthma, and multiple autoimmune conditions underline methylprednisolone’s therapeutic relevance.
• WHO estimates a prevalence increase of autoimmune diseases by 5% annually globally, bolstering demand.

2. Expansion of Indications and Usage Paradigms

Condition	Approved Uses	Emerging Off-Label Uses
Asthma, COPD	Acute exacerbations	Long-term control in select cases
Rheumatoid arthritis	Flare management	Adjunct in autoimmune therapy
Allergic reactions	Severe allergic responses	Off-label for immunosuppression
Multiple sclerosis	Relapse management	Investigated for neuroprotection

• Growing approval for IV and oral formulations, including pulse therapy, widens clinical application scope.

3. Pharmacological Profile Favoring Usage

• Rapid onset of action
• Established efficacy
• Favorable safety profile with manageable side effects when used appropriately

4. Technological and Manufacturing Advances

• Development of biosimilars and generic versions enhances affordability.
• Enhanced formulation stability and bioavailability extend patient compliance.

5. Healthcare Policy and Guidelines

• Inclusion in many national essential medicines lists (EMLs)
• Therapeutic guidelines recommending corticosteroids for acute and chronic management

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What Challenges and Constraints Affect Market Growth?

1. Patent Expirations and Generic Competition

• Methylprednisolone’s primary formulations entered generic markets post-2010.
• Generics capture over 85% of market volume, reducing per-unit revenue.

2. Side Effect Profile and Safety Concerns

• Long-term corticosteroid use linked to osteoporosis, hyperglycemia, and immunosuppression.
• Regulatory agencies enforce strict usage guidelines, occasionally limiting indications.

3. Regulatory Hurdles and Pricing Pressures

• Stringent approval processes for new formulations.
• Governments and payers increasingly focus on cost containment, pressuring prices.

4. Market Saturation and Competition from Alternative Agents

• Growing use of biologics and targeted immunomodulators reduce corticosteroids’ market share.
• Novel therapies in autoimmune and inflammatory diseases threaten traditional corticosteroid roles.

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Financial Trajectory and Market Forecasts

Current Market Size and Segmentation (2022)

Segment	Value (USD millions)	Market Share (%)	Growth Rate (%)
Oral formulations	580	61.1	4.1
Injectable formulations	370	38.9	4.4

Geographical Breakdown (2022)

Region	Market Size (USD millions)	Share (%)	CAGR (2023–2030) (%)
North America	340	35.8	3.5
Europe	280	29.5	3.7
Asia-Pacific	220	23.2	6.0
Rest of the World	110	11.5	4.8

Projected Growth to 2030

• Compound Annual Growth Rate (CAGR): 4.2%
• Market Valuation (2030): Approx. USD 1.4 billion

Key Growth Factors

• Increase in biosimilar and generic entries.
• Geographic expansion into emerging markets.
• Rising adoption in outpatient and hospital settings.
• Adoption of novel delivery systems (e.g., emergency-use formulations).

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Competitive Landscape and Major Players

Company	Market Share (%)	Notable Products	Strategic Moves
Pfizer	25	Methylprednisolone acetate injections	Patent licensing, R&D investments
Teva	20	Generic methylprednisolone formulations	Broad generic portfolio
Mylan	15	Oral and injectable methylprednisolone	Market expansion in emerging markets
Sandoz	10	Biosimilar versions, formulations	Biosimilar pipeline expansion
Sun Pharma	8	Various corticosteroids	Local manufacturing, pricing strategies

Note: Market shares are estimates based on available sales data and industry reports.

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Regulatory and Policy Influences

Global Regulatory Environment

• Stringent FDA and EMA approval metrics for new formulations.
• WHO Essential Medicines List inclusion since 1977.

Pricing and Reimbursement Policies

Region	Policy Highlights	Impact on Market
North America	Price negotiations, formulary restrictions	Price pressures, focus on generics
Europe	Nationalized healthcare systems, EML inclusion	Favorable for established generics
Asia-Pacific	Rapidly evolving policies, rising healthcare access	Increased market penetration and local production

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Comparison with Alternative Therapies

Therapy Type	Advantages	Limitations	Market Position
Corticosteroids (e.g., methylprednisolone)	Rapid action, broad indications	Side effects, long-term safety concerns	First-line for acute exacerbations, multiple indications
Biologics (e.g., TNF inhibitors)	Targeted action, fewer systemic effects	High cost, administration route	Limited to specific autoimmune conditions, niche markets
Conventional immunosuppressants	Cost-effective, established	Toxicity profile, delayed onset	Used adjunctively, declining position in some indications

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Deep Dive: Future Innovation and Market Opportunities

Emerging Trends

• Development of Long-Acting Formulations: Novel depot injections to improve compliance.
• Immunomodulatory Combinations: Combining corticosteroids with biologics to enhance efficacy.
• Precision Medicine Approaches: Patient-specific dosing regimens guided by biomarkers.
• Biosimilars Expansion: Lower-cost options increasing access worldwide.

Potential Market Opportunities

• Expanding use in emerging markets due to improving healthcare infrastructure.
• Formulation innovations targeting outpatient and emergency settings.
• Developing niche indications where corticosteroids are currently secondary.

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Key Takeaways

• Market Size & Growth: The methylprednisolone market is projected to reach USD 1.4 billion by 2030, with steady CAGR of 4.2%, driven by increasing disease prevalence and expanded indications.
• Competitive Landscape: Dominated by generic manufacturers, but innovation in formulations and biosimilars will shape future growth.
• Regulatory & Policy Impact: Stringent regulations and pricing pressures necessitate strategic compliance and cost management.
• Challenges: Patent expirations, side effect concerns, and competition from biologics diminish growth prospects.
• Opportunities: Focus on biosimilars, regional expansion, and formulation advancements to sustain market relevance.

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Frequently Asked Questions

1. What are the main therapeutic indications for methylprednisolone?

Methylprednisolone is primarily used to treat inflammatory conditions such as arthritis, allergic reactions, asthma exacerbations, multiple sclerosis relapses, and certain dermatologic conditions.

2. How is the market for methylprednisolone expected to evolve through 2030?

The market is forecasted to grow modestly at around 4.2% annually, reaching approximately USD 1.4 billion. Growth will be supported by new formulations, higher prevalence of target diseases, and regional market expansion.

3. Who are the dominant players in the methylprednisolone market?

Key players include Pfizer, Teva, Mylan, Sandoz, and Sun Pharma, primarily providing generic and biosimilar versions. Their market shares fluctuate based on regional strategies and product pipelines.

4. What are the main challenges facing methylprednisolone market growth?

Patent expirations, safety concerns, regulatory restrictions, and rising competition from biologics are significant barriers. Cost pressures from healthcare systems also limit pricing flexibility.

5. Are biosimilars impacting the methylprednisolone market?

Yes; biosimilars and generic formulations are expected to continue lowering prices and increasing accessibility, thereby influencing overall revenues and market share distribution.

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References

1. World Health Organization. "Autoimmune Diseases," 2020.
2. Grand View Research. "Corticosteroids Market Size, Share & Trends Analysis," 2022.
3. U.S. Food and Drug Administration. "FDA Approvals and Labeling," 2021.
4. European Medicines Agency. "Market Authorizations for Corticosteroids," 2022.
5. IQVIA Institute. "The Global Use of Medicines," 2022.

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This comprehensive review offers critical insights into the dynamics shaping methlyprednisolone’s market trajectory, assisting pharmaceutical stakeholders, investors, and policy-makers in strategic decision-making.