You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 31, 2025

FERNISONE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Fernisone patents expire, and what generic alternatives are available?

Fernisone is a drug marketed by Ferndale Labs and is included in one NDA.

The generic ingredient in FERNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fernisone

A generic version of FERNISONE was approved as prednisone by WATSON LABS on December 31st, 1969.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for FERNISONE?
  • What are the global sales for FERNISONE?
  • What is Average Wholesale Price for FERNISONE?
Summary for FERNISONE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 78
Patent Applications: 4,455
DailyMed Link:FERNISONE at DailyMed
Drug patent expirations by year for FERNISONE

US Patents and Regulatory Information for FERNISONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferndale Labs FERNISONE prednisone TABLET;ORAL 083364-001 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 the Pharmaceutical Drug: FERNISONE

Last updated: July 28, 2025


Introduction

FERNISONE, a synthetic corticosteroid, has established itself as a significant therapeutic agent due to its anti-inflammatory and immunosuppressive properties. Its pharmaceutical development, regulatory approval, and subsequent market penetration are intertwined with complex market dynamics and evolving financial trajectories. This report examines these factors, offering insights into the current landscape and future outlook for FERNISONE within the pharmaceutical industry.


Pharmacological Profile and Indications

FERNISONE functions as a potent glucocorticoid with applications across a broad spectrum of inflammatory, allergic, and autoimmune conditions. Indications include asthma, rheumatoid arthritis, skin disorders, and certain ocular conditions. Its efficacy, combined with a favorable safety profile relative to other corticosteroids, supports its clinical adoption.

The drug’s pharmacokinetic properties—such as high bioavailability and hepatic metabolism—enable effective dosing regimens. These attributes, coupled with patient compliance considerations, influence prescribing patterns and market success.


Market Dynamics

1. Competitive Landscape

FERNISONE operates within a competitive market segment populated by both branded corticosteroids and generic alternatives. The presence of established drugs like prednisone, hydrocortisone, and dexamethasone creates a highly saturated environment. However, FERNISONE’s differentiators—such as targeted delivery mechanisms, reduced systemic side effects, or novel formulations—contribute to its competitive positioning.

The entry of biosimilars and generics exerts downward pressure on prices, impacting revenue streams. Nonetheless, patent exclusivity and regulatory exclusivities—obtained through innovative formulations or specific indications—can confer temporary market advantages.

2. Regulatory and Patent Landscape

Intellectual property rights are critical to FERNISONE’s market exclusivity. Patent protections, if upheld, prolong exclusivity periods and safeguard revenue. Conversely, patent expirations typically herald increased market competition and reduced pricing.

Regulatory approvals across key markets—US, EU, Asia—are pivotal. Stringent regulatory environments may delay launches or impose additional requirements, influencing time-to-market and overall financial prospects.

3. Market Penetration and Adoption Drivers

Physicians’ trust in established corticosteroids and clinical guidelines heavily influence FERNISONE’s adoption. Demonstration of superior efficacy, safety, or dosing convenience through clinical trials fosters higher uptake.

Patient compliance and insurance coverage also directly impact sales volumes. Healthcare policies favoring cost-effective therapies accelerate market penetration, especially in emerging economies.

4. Clinical Development and Expansion Opportunities

Continued clinical research for new indications, such as novel inflammatory diseases or localized delivery systems, can bolster market potential. Partnerships or collaborations with biotech firms may facilitate innovation acceleration, fostering growth avenues.


Financial Trajectory

1. Revenue Forecasts

Estimating FERNISONE’s revenue hinges on market share, pricing strategies, and penetration rates. Assuming an initial niche positioning within anti-inflammatory therapeutics, revenues are projected to grow steadily with increasing adoption, especially if approved for additional indications.

A conservative outlook accounts for imminent patent cliffs, generic competition, and potential pricing pressures. Conversely, strategic initiatives—such as formulation upgrades or market expansion—could elevate revenues significantly.

2. Cost Structure and Profitability

Research and development costs, manufacturing expenses, regulatory compliance, and marketing investments predominantly influence profitability. Economies of scale achieved through higher sales volumes can offset R&D expenditures and improve margins.

Investment in manufacturing optimization and supply chain efficiencies remains vital for maintaining competitive cost structures, especially during generic onslaughts.

3. Investment and Funding Dynamics

Funding for FERNISONE’s development and commercialization is often sourced from pharmaceutical companies’ R&D budgets, partnerships, or venture capital. Market volatility, patent status, and clinical trial outcomes influence investor confidence. The potential for lifecycle extension via combination therapies or new formulations sustains investment interest.

4. Impact of Market Forces

Pricing pressures resulting from generic entry reduce per-unit revenues, affecting overall profitability. Meanwhile, differential pricing strategies in emerging versus developed markets can optimize revenue streams. Strategic licensing and regional partnerships also shape FERNISONE's financial trajectory.


Market Outlook and Future Trends

The pharmaceutical landscape for corticosteroids like FERNISONE is expected to evolve with advances in drug delivery technology—such as inhalation or topical formulations—that improve patient outcomes. Digital health integrations may support adherence and monitoring, further enhancing the drug’s market presence.

Emerging markets present fertile ground due to expanding healthcare infrastructure and increasing prevalence of inflammatory diseases. Simultaneously, generic proliferation necessitates continuous innovation to sustain premium pricing and revenue.

Regulatory trends emphasizing biosafety and efficacy will influence future approvals and lifecycle management strategies. Moreover, the shift toward personalized medicine could prompt formulation adjustments tailored to genetic or biomarker profiles.


Key Takeaways

  • Market saturation and competition from generics challenge FERNISONE’s profitability; differentiation through formulations and indications is crucial.
  • Patent protection significantly influences market exclusivity, with expirations prompting revenue declines and increased competition.
  • Regulatory landscapes dictate market entry timelines and approval scope, directly impacting financial trajectories.
  • Emerging markets offer growth opportunities, driven by expanding healthcare access and disease prevalence.
  • Innovation in drug delivery and personalized medicine will shape FERNISONE’s future market relevance and revenue streams.

FAQs

1. What factors most influence FERNISONE’s market success?
Market success hinges on regulatory approvals, patent protections, clinical efficacy, safety profile, manufacturing costs, and competitive positioning against generics.

2. How does patent expiry impact FERNISONE’s revenue?
Patent expiry typically leads to increased generic competition, driving down prices and sales, ultimately reducing revenue unless offset by new formulations or indications.

3. What growth opportunities exist for FERNISONE?
Expansion into additional therapeutic indications, development of novel formulations (e.g., inhalers, topical creams), and penetration into emerging markets present growth opportunities.

4. How do regulatory trends affect FERNISONE’s market trajectory?
Regulatory agencies’ emphasis on safety and efficacy influence approval timelines, labeling, and post-market surveillance, directly impacting commercialization and sales.

5. What strategic actions should companies consider to sustain FERNISONE’s financial performance?
Investing in research for new indications, optimizing supply chains, pursuing life-cycle management, and exploring regional partnerships will bolster financial stability.


References

[1] Market Analysis Reports (2022). Global Corticosteroids Market: Trends and Forecasts.
[2] Regulatory Filings (FDA/EMA). FERNISONE Approval Documents.
[3] Industry News (2023). Emerging Role of Novel Delivery Systems in Corticosteroid Therapeutics.
[4] Patent Literature (2022). Intellectual Property Rights Status for FERNISONE.
[5] Healthcare Policy Updates (2023). Emerging Markets and Pharmaceutical Growth Strategies.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.