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Last Updated: December 17, 2025

Methylprednisolone; neomycin sulfate - Generic Drug Details


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

Methylprednisolone; neomycin sulfate is the generic ingredient in one branded drug marketed by Pharmacia And Upjohn and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for methylprednisolone; neomycin sulfate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:methylprednisolone; neomycin sulfate at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for methylprednisolone; neomycin sulfate
A01AB Antiinfectives and antiseptics for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07AA Antibiotics
A07A INTESTINAL ANTIINFECTIVES
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
B05CA Antiinfectives
B05C IRRIGATING SOLUTIONS
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
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
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
J01GB Other aminoglycosides
J01G AMINOGLYCOSIDE ANTIBACTERIALS
J01 ANTIBACTERIALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R02AB Antibiotics
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
S01AA Antibiotics
S01A ANTIINFECTIVES
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
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for methylprednisolone; neomycin sulfate

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 NEO-MEDROL methylprednisolone; neomycin sulfate OINTMENT;OPHTHALMIC 060645-001 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 Methylprednisolone and Neomycin Sulfate

Last updated: August 1, 2025


Introduction

The pharmaceuticals market for methylprednisolone and neomycin sulfate is shaped by evolving clinical needs, regulatory landscapes, and competitive forces. These drugs, integral in managing inflammation, immune responses, and bacterial infections, face trafficking within dynamic healthcare settings, impacting their market sizes and financial prospects. Recognizing the distinct and overlapping market drivers is critical for stakeholders aiming to navigate existing opportunities and mitigate risks.


Market Overview

Methylprednisolone: An Anti-Inflammatory Mainstay

Methylprednisolone, a corticosteroid, is extensively prescribed to treat inflammatory and autoimmune conditions such as multiple sclerosis, arthritis, and allergic reactions (1). Its formulations range from oral tablets to injectable forms, underpinning a diverse product portfolio. The drug’s global sales reached approximately USD 1.2 billion in 2022, reflecting steady demand driven by chronic disease prevalence and acute inflammatory cases (2).

Neomycin Sulfate: A Critical Antibiotic

Neomycin sulfate, an aminoglycoside antibiotic, primarily addresses bacterial infections of the gastrointestinal and skin, including topical or oral applications. Its segment is consolidated by formulations used as part of combination therapies and as standalone treatments in preoperative settings. The global market stood at about USD 500 million in 2022, influenced by rising antimicrobial resistance (AMR) concerns and the push for new antibiotic formulations (3).


Market Dynamics

1. Clinical and Therapeutic Trends

Advances in disease management have driven sustained demand. For methylprednisolone, the rising incidence of autoimmune diseases and expanding indications for corticosteroids sustain demand. COVID-19’s impact, especially the use of steroid therapy during the pandemic, temporarily boosted methylprednisolone prescriptions; however, post-pandemic stabilization is observed (4).

In contrast, neomycin’s market is increasingly impacted by antimicrobial resistance and regulatory scrutiny. The decline of some traditional antibiotics prompts a shift toward novel delivery methods and combination therapies involving neomycin, especially in gastrointestinal infections.

2. Regulatory and Patent Landscapes

Methylprednisolone benefits from an expansive patent life and generic availability, fostering price competition and wider access. However, the expiration of key patents in developed markets like the US and Europe has led to a surge in generics, exerting downward pressure on prices (5).

Neomycin, largely off-patent, faces limited patent-related exclusivity. Regulations emphasizing antimicrobial stewardship restrict the use of older antibiotics, influencing market growth and reimbursement policies, especially across Europe and North America (6).

3. Manufacturing and Supply Chain Factors

Supply chain disruptions, notably during the COVID-19 pandemic, highlighted vulnerabilities in sourcing raw materials and production capacity. For methylprednisolone, reliance on specific intermediates from Asia raises geopolitical and logistic concerns. Neomycin’s production, while stable, faces challenges related to fermentation processes and biosafety.

4. Competition and Innovation

The methylprednisolone market sees intense competition among branded products and generics, with biosimilars and extended-release formulations entering the scene. These innovations focus on improving patient compliance and reducing side effects.

Neomycin faces competition from newer antibiotics with broader spectra or better safety profiles. Additionally, the development pipeline emphasizes targeted delivery systems and combination drugs to combat resistance.


Financial Trajectory

Revenue Projections

  • Methylprednisolone: Market analysts project a compound annual growth rate (CAGR) of approximately 3-4% over the next five years, driven by increasing global autoimmune disease burdens and expanding therapeutic indications. Markets in Asia-Pacific are expected to outpace mature markets due to rising healthcare spending.

  • Neomycin Sulfate: The market is expected to grow modestly at a CAGR of around 1-2%, constrained by antimicrobial stewardship policies. Emerging markets provide some growth avenues, especially in rural healthcare and surgical prophylaxis.

Pricing and Cost Trends

The widespread availability of generics for methylprednisolone has led to significant price erosion—average unit costs declined by 20-30% globally since patent expiry. For neomycin, price stabilization is partly due to limited competition, although regulatory constraints can alter pricing strategies.

Manufacturing costs, particularly for neomycin, are influenced by fermentation technology advancements and biosafety compliances, with production costs expected to stabilize or marginally decrease in the coming years.

Market Risks and Opportunities

  • Risks: Regulatory hurdles, antimicrobial resistance development, and competitive patent litigations threaten profitability. Disruptions in supply chains also pose ongoing risks.

  • Opportunities: Expansion into emerging markets, development of new formulations, and strategic alliances for novel drug delivery can unlock growth. For methylprednisolone, biosimilar entry and personalized medicine approaches offer new revenue streams.


Geographical Market Insights

  • United States: A mature market dominated by generics, with growth driven by new indications and biosimilars for methylprednisolone. Regulatory scrutiny on antibiotics like neomycin limits expansion.

  • Europe: Stringent antimicrobial policies impact neomycin sales, with methylprednisolone’s market stabilized by established healthcare systems and biosimilar proliferation.

  • Asia-Pacific: Rapidly expanding markets, with high unmet medical needs, offer lucrative opportunities for both drugs, especially in China and India, driven by increasing healthcare access and prescription rates.

  • Rest of the World: Latin America and Africa present growth potential amid rising disease prevalence, with economic constraints affecting pricing strategies.


Strategic Outlook

The market for methylprednisolone appears poised for moderate growth, bolstered by expanded indications and biosimilar competition, which will pressure prices yet expand access. Neomycin’s trajectory remains subdued, constrained by antimicrobial stewardship and resistance concerns, though niche applications and formulations sustain its relevance.

Investing in formulation innovations, global market expansion, and strategic partnerships can enhance revenue streams. Stakeholders should monitor geopolitical factors influencing raw material supply and regulatory landscapes dictating antibiotic use.


Key Takeaways

  • Methylprednisolone holds a stable, growing market, driven by autoimmune disease prevalence and biosimilar entry, with evolving formulation options supporting sustained revenues.

  • Neomycin sulfate faces headwinds from antimicrobial resistance and regulatory restrictions but maintains niche importance, especially in surgical and gastrointestinal applications.

  • Market competition is intensifying, emphasizing innovation, cost management, and regulatory compliance to protect margins and market share.

  • Geographical expansion, particularly in emerging markets, offers significant growth prospects for both drugs, contingent on navigating local regulatory environments.

  • Supply chain resilience and technological advances in manufacturing are critical to sustain profitability and meet global demand.


FAQs

1. What are the primary drivers behind methylprednisolone’s market growth?
The increase in autoimmune and inflammatory disease prevalence, broader therapeutic indications, and biosimilar competition are primary growth drivers. The COVID-19 pandemic also temporarily boosted demand due to steroid therapy protocols.

2. How does antimicrobial resistance impact neomycin sulfate's market prospects?
Rising AMR reduces the effectiveness of traditional antibiotics like neomycin, prompting regulatory restrictions and favoring newer agents. This constrains market growth but maintains niche applications where resistance is manageable.

3. Are there notable regulatory challenges for these drugs?
Yes. For methylprednisolone, patent expirations lead to increased generic competition, while for neomycin, strict antimicrobial stewardship policies limit usage in certain markets, influencing commercialization strategies.

4. How is technological innovation affecting these markets?
Formulation improvements, such as long-acting steroids or combination therapies involving methylprednisolone, enhance patient compliance. For neomycin, advanced delivery systems and combination products aim to address resistance issues and improve efficacy.

5. What emerging markets show promise for these drugs?
Asia-Pacific, Latin America, and Africa demonstrate considerable growth potential due to expanding healthcare access, increasing disease burdens, and changing prescribing practices, although regulatory and infrastructure challenges persist.


Sources:
[1] Global Data, "Methylprednisolone Market Analysis," 2022.
[2] IQVIA, "Pharmaceutical Sales Data," 2022.
[3] MarketWatch, "Neomycin Sulfate Market Trends," 2022.
[4] WHO, "Steroid Use in COVID-19," 2021.
[5] U.S. Patent Office, "Patent Trends for Generic Steroids," 2021.
[6] EMA Guidelines, "Antibiotic Stewardship and Regulatory Policies," 2022.

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