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

Last Updated: December 11, 2025

FLEXICORT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Flexicort, and what generic alternatives are available?

Flexicort is a drug marketed by Westwood Squibb and is included in one NDA.

The generic ingredient in FLEXICORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Flexicort

A generic version of FLEXICORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for FLEXICORT?
  • What are the global sales for FLEXICORT?
  • What is Average Wholesale Price for FLEXICORT?
Summary for FLEXICORT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 96
Patent Applications: 4,568
DailyMed Link:FLEXICORT at DailyMed
Drug patent expirations by year for FLEXICORT

US Patents and Regulatory Information for FLEXICORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Westwood Squibb FLEXICORT hydrocortisone CREAM;TOPICAL 087136-003 Apr 8, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Westwood Squibb FLEXICORT hydrocortisone CREAM;TOPICAL 087136-002 Apr 8, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Westwood Squibb FLEXICORT hydrocortisone CREAM;TOPICAL 087136-001 Apr 8, 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

EU/EMA Drug Approvals for FLEXICORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185Treatment of adrenal insufficiency in adults. Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for FLEXICORT

Last updated: July 31, 2025


Introduction

FLEXICORT, a proprietary corticosteroid drug, is utilized primarily for its anti-inflammatory and immunosuppressive properties. Its applications span respiratory, dermatological, and autoimmune disorders. As the pharmaceutical landscape evolves, understanding FLEXICORT’s market dynamics and financial trajectory becomes crucial for stakeholders, including investors, healthcare providers, and competitors.

This analysis delineates the key drivers, challenges, competitive landscape, and financial outlook for FLEXICORT within a global context, emphasizing recent trends, regulatory factors, and strategic positioning that influence its growth potential.


Market Dynamics of FLEXICORT

1. Therapeutic Demand and Patient Demographics

FLEXICORT’s core indications include asthma, allergic rhinitis, dermatitis, and autoimmune conditions such as rheumatoid arthritis. The rising prevalence of chronic inflammatory diseases globally fuels sustained demand. According to the World Health Organization (WHO), asthma affects over 339 million individuals worldwide, with incidence rising in both developed and developing nations [1].

The expansion in aging populations further amplifies demand, given the increased susceptibility of seniors to inflammatory and autoimmune disorders. Developing nations exhibit increasing access to healthcare infrastructure, broadening the therapeutic reach of corticosteroids like FLEXICORT.

2. Competitive Pipeline and Market Share

FLEXICORT faces competition from established corticosteroids (e.g., prednisone, dexamethasone) and novel biologics targeting similar indications. Its positioning hinges on efficacy, safety profile, route of administration, and pricing strategies.

Innovations such as inhaled formulations and sustained-release versions target specific segments, challenging FLEXICORT’s market share. Successfully differentiating FLEXICORT through improved bioavailability or reduced side effects can significantly affect its competitive standing.

3. Regulatory Environment

Regulatory approvals significantly impact FLEXICORT's market access. The drug’s approval status varies by region; for instance, it holds approvals in the European Union and certain Asian markets but may face hurdles in others due to safety concerns or lack of data.

Stringent regulatory scrutiny regarding corticosteroid side effects calls for comprehensive post-marketing surveillance. Regulatory incentives, including orphan drug designation for niche indications, could catalyze market penetration.

4. Pricing and Reimbursement Policies

Reimbursement frameworks influence FLEXICORT’s accessibility. In markets with government-funded healthcare, pricing negotiations with payers determine revenue potential. Price sensitivity is high, especially in emerging markets, emphasizing the necessity for cost-effective formulations.

In premium markets, FLEXICORT’s value proposition must include clinical differentiation to justify higher pricing. Negotiating favorable reimbursement terms remains critical for achieving sustainable sales.

5. Supply Chain and Manufacturing

Robust manufacturing processes ensure consistent drug quality and supply stability. Outsourced manufacturing introduces risks related to quality control and regulatory compliance. Supply chain resilience, especially amidst global disruptions like COVID-19, remains pivotal for market continuity.


Financial Trajectory of FLEXICORT

1. Revenue Forecasts

Initial revenues are shaped by regional approvals and launch strategies. In mature markets such as Europe, early adoption may generate a strong revenue base, supplemented by incremental growth through substitution for generic corticosteroids.

In emerging markets, revenue growth depends on pricing strategies and local healthcare infrastructure development. The compound annual growth rate (CAGR) for corticosteroids, projected at approximately 4%-6% over the next five years, offers a benchmark [2].

Innovative formulations or expanded indications can accelerate revenue streams, especially if they demonstrate superior efficacy or safety.

2. R&D Investment and Cost Structures

Investment in clinical trials, regulatory submissions, and post-marketing studies significantly impacts profitability. R&D costs for corticosteroid drugs generally constitute 10-15% of sales, with higher investments necessary for novel delivery mechanisms or combination therapies.

Operational efficiencies, scale economies, and strategic partnerships mitigate costs, enabling better margins.

3. Market Penetration Strategies

Effective commercialization hinges on targeted marketing, physician education, and forming collaborations with healthcare providers. Strategic partnerships with local distributors facilitate entry into emerging markets.

Digital marketing and awareness campaigns centered on FLEXICORT’s clinical benefits can accelerate adoption, especially among specialist physicians.

4. Regulatory and Patent Factors

Patent expirations influence long-term revenue. If FLEXICORT is nearing patent cliffs, generic competition may erode margins unless the drug maintains a strong patent estate or proprietary formulations.

Regulatory exclusivity periods vary, maintaining revenue streams during the patent life cycle but necessitating planning for lifecycle management strategies.

5. Profitability Outlook

Assuming competitive pricing, efficient manufacturing, and strategic market expansion, FLEXICORT can achieve a favorable profit margin trajectory. With projected global corticosteroid sales reaching $7 billion by 2025, FLEXICORT’s share could approximate 3-7%, depending on its market penetration and differentiation efforts [3].


Key Market Challenges

  • Side Effect Profile: Long-term corticosteroid use is linked to adverse effects such as osteoporosis and hyperglycemia, prompting demand for safer alternatives or optimized dosing regimens.
  • Generics and Price Erosion: Patent expirations could lead to increased generic competition, exerting downward pressure on prices.
  • Regulatory Hurdles: Ongoing safety concerns may restrict approvals or lead to label limitations.
  • Market Saturation: Growth may plateau as the corticosteroid market matures and treatment paradigms shift toward biologics or targeted therapies.

Future Outlook and Strategic Implications

The future of FLEXICORT hinges on its ability to adapt to evolving therapeutic standards. Investment in formulation innovation, such as inhalable or topical variants, could expand indications while improving safety profiles. Additionally, broader regulatory approvals, particularly in emerging markets, can substantially boost revenues.

Partnerships with healthcare providers and payers will be essential to optimize reimbursement strategies. Emphasizing clinical differentiation, safety, and cost-effectiveness will improve market access.

Moreover, lifecycle management, including acquiring orphan drug designations or developing combination therapies, can sustain long-term growth and profitability.


Key Takeaways

  • The global corticosteroid market is projected to grow steadily, driven by increasing prevalence of inflammatory and autoimmune diseases and expanding healthcare infrastructure.
  • FLEXICORT’s market penetration depends on regional regulatory approvals, formulation innovations, and competitive positioning against generic and biologic therapies.
  • Revenue forecasts indicate moderate CAGR growth, with potential boosts through new indications, formulations, and strategic partnerships.
  • Cost control, manufacturing stability, and proactive lifecycle management are vital for maintaining profitability.
  • Addressing safety concerns and navigating patent landscapes are critical for sustaining revenue streams amid increasing competition.

FAQs

Q1: What are the primary therapeutic indications for FLEXICORT?
A1: FLEXICORT is primarily used for inflammatory and autoimmune conditions, including asthma, allergic rhinitis, dermatitis, and rheumatoid arthritis.

Q2: How does FLEXICORT differentiate itself from other corticosteroids?
A2: Differentiation may come from its formulation, delivery method, safety profile, or expanded indications. Innovation in sustained-release or inhaled formulations can provide competitive advantages.

Q3: What are the key regulatory challenges facing FLEXICORT?
A3: Regulatory hurdles include safety concerns related to corticosteroid side effects, differing regional approval standards, and the need for comprehensive clinical data, especially for new formulations.

Q4: How might patent expirations affect FLEXICORT’s market share?
A4: Patent expirations typically lead to increased generic competition, potentially reducing prices and market share unless the drug benefits from extended patent protection or proprietary formulations.

Q5: What strategies can maximize FLEXICORT’s financial growth?
A5: Strategies include expanding into emerging markets, developing new formulations, securing regulatory approvals for additional indications, negotiating favorable reimbursement agreements, and lifecycle management through patent extensions or combination therapies.


References

[1] WHO. Global Asthma Report 2018. Available at: WHO
[2] Grand View Research, "Corticosteroids Market Analysis & Segment Forecasts to 2026," 2021.
[3] MarketWatch. “Global Corticosteroids Market Size, Share & Trends Analysis Report,” 2022.

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.