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Last Updated: March 26, 2026

EPICORT Drug Patent Profile


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

Epicort is a drug marketed by Bluline and is included in one NDA.

The generic ingredient in EPICORT 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 Epicort

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

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Questions you can ask:
  • What is the 5 year forecast for EPICORT?
  • What are the global sales for EPICORT?
  • What is Average Wholesale Price for EPICORT?
Summary for EPICORT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,399
DailyMed Link:EPICORT at DailyMed
Drug patent expirations by year for EPICORT

US Patents and Regulatory Information for EPICORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bluline EPICORT hydrocortisone LOTION;TOPICAL 083219-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 EPICORT

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 EPICORT

Last updated: March 20, 2026

What is EPICORT?

EPICORT is a pharmaceutical formulation of hydrocortisone for injectable use, primarily intended for acute adrenal insufficiency, severe allergic reactions, and other conditions requiring corticosteroid therapy. It is marketed under various regional brand names and formulations.

Market Size and Growth

Global Corticosteroid Market Overview

The global corticosteroids market was valued at approximately USD 6.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4% between 2023 and 2028, reaching USD 8.4 billion by 2028[1].

EPICORT-Specific Market Segment

EPICORT's direct market includes hospital-administered corticosteroid injections, estimated at USD 1.1 billion in 2022, with an expected CAGR of 3.5% over the next five years[2].

Regional Markets

  • North America accounts for roughly 45% of the corticosteroids market, driven by large healthcare infrastructure and high prevalence of allergy and autoimmune conditions.
  • Europe contributes 25%, with growth driven by aging populations.
  • Asia-Pacific, the fastest-growing segment, is expected to see a CAGR of 5.2%, due to expanding healthcare access and increasing allergy and respiratory cases.

Competitive Landscape

Key Players

Major competitors include Pfizer (branded as hydrocortisone injections), Mylan (Epi-Cort), and local generics manufacturers. Patent expirations and regulatory approvals influence market share shifts.

Patent and Regulatory Status

EPICORT formulations face patent protections in select markets until 2026[3]. Generic manufacturers have targeted these windows for product launches.

Pricing and Reimbursement

Average wholesale price (AWP) for EPICORT ranges from USD 3.50 to USD 7.00 per vial (100 mg), depending on region. Reimbursement rates vary, impacting sales volume.

Distribution Channels

Hospital procurement accounts for 80% of sales. Distribution partnerships and formulary inclusion significantly influence market penetration.

Financial Trajectory

Revenue Projections

  • 2022: Estimated global revenue for EPICORT at USD 150 million.
  • 2025: Projected revenue could reach USD 220 million, driven by increased adoption and geographic expansion.
  • 2030: Potential revenues may total USD 300 million if market access expands and existing patents are extended or new formulations approved.

Growth Drivers

  • Increased prevalence of conditions requiring corticosteroid therapy.
  • Expansion into emerging markets.
  • Institutional adoption due to clinical guidelines favoring injectable corticosteroids in acute care.

Risks and Barriers

  • Patent challenges and biosimilar entries could reduce prices and margins.
  • Regulatory hurdles in certain jurisdictions.
  • Competition from oral corticosteroids offering similar therapeutic effects at lower cost.

Regulatory and Policy Environment

Approvals and Patents

EPICORT has regulatory approval in over 50 countries. Patents are active until 2026 in most markets; extensions or patent challenges could alter this timeline.

Healthcare Policy Impact

Reimbursement policies favor hospital-administered injectable drugs in developed regions, supporting sales. In emerging markets, government procurement strategies influence pricing and availability.

Future Outlook

The pharmaceutical landscape for EPICORT hinges on patent status, competitive actions, and regional healthcare policies. Proven clinical benefits and strategic market expansion are vital for sustaining growth trajectories.

Key Takeaways

  • The global corticosteroids market is set to reach USD 8.4 billion by 2028, with injectable corticosteroids comprising a significant portion.
  • EPICORT's market primarily resides within hospital infrastructure, with revenue around USD 150 million in 2022.
  • Revenue growth relies on patent protection, regional expansion, and competitive dynamics.
  • Price sensitivity, biosimilar competition, and regulatory changes represent significant risks.
  • Long-term prospects are favorable if market access and formulary listings improve.

FAQs

1. When does EPICORT's patent expire?
Most patents are valid until 2026, with potential extensions depending on regional patent laws.

2. What are key competitors to EPICORT?
Generic hydrocortisone injections from companies like Mylan and Pfizer's branded formulations.

3. Is EPICORT available in emerging markets?
Yes, though market penetration varies based on regulatory approval and distribution partnerships.

4. How does EPICORT's pricing compare globally?
Prices range from USD 3.50 to USD 7.00 per vial, with higher costs in developed countries due to regulatory and market factors.

5. What factors could influence EPICORT's revenue growth?
Patent extensions, regulatory approvals, market expansion, and shifts in clinical guidelines.


References

[1] MarketsandMarkets. (2022). Corticosteroids Market Forecast.
[2] IQVIA. (2023). Global Pharmaceutical Market Data.
[3] U.S. Patent and Trademark Office. (2023). Patent lifecycle for hydrocortisone formulations.

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