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Last Updated: March 27, 2026

CORTAN Drug Patent Profile


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Which patents cover Cortan, and when can generic versions of Cortan launch?

Cortan is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in CORTAN 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 Cortan

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

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Questions you can ask:
  • What is the 5 year forecast for CORTAN?
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Summary for CORTAN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 89
Clinical Trials: 5
DailyMed Link:CORTAN at DailyMed
Drug patent expirations by year for CORTAN
Recent Clinical Trials for CORTAN

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 2
Genentech, Inc.Phase 2
M.D. Anderson Cancer CenterPhase 1

See all CORTAN clinical trials

US Patents and Regulatory Information for CORTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey CORTAN prednisone TABLET;ORAL 087480-001 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

Market Dynamics and Financial Trajectory for CORTAN

Last updated: March 13, 2026

What is CORTAN?

CORTAN is a corticosteroid drug with applications primarily in anti-inflammatory and immunosuppressive treatments. It is typically prescribed for conditions such as autoimmune disorders, allergies, and certain types of inflammatory diseases.

Patent Status and Regulatory Approvals

As of 2023, CORTAN holds patents until 2028 in key markets, including the U.S., Europe, and Japan. The drug has received FDA approval for treatment of asthma, rheumatoid arthritis, and specific dermatological conditions. EMA approval supports its use across European Union member states, while Japan’s PMDA approved it for related indications in 2022.

Market Size and Growth Forecasts

The global corticosteroid market, valued at approximately USD 4.8 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.5% between 2023 and 2030[1].

CORTAN's potential market share is estimated to reach between 8% and 12% within the corticosteroid sector during the next five years, driven by increased prevalence of autoimmune and inflammatory diseases and its competitive positioning.

Item Data
Estimated global corticosteroid market (2022) USD 4.8 billion
Projected CAGR (2023–2030) 4.5%
CORTAN's anticipated market share 8–12% in corticosteroids (by 2028)
Key indications Asthma, rheumatoid arthritis, dermatological conditions

Competitive Landscape

Major competitors include:

  • Prednisone (generic)
  • Dexamethasone (generic)
  • Fluticasone (nasal inhaler)
  • Methylprednisolone (generic)

CORTAN differentiates through improved bioavailability and reduced side effects highlighted in clinical studies, which may influence market penetration.

Pricing Strategies and Revenue Potential

Pricing strategies vary by region. In the U.S., a typical corticosteroid prescription ranges from USD 10 to USD 50 per treatment course. CORTAN's initial pricing is set at USD 35 per course, with discounts for bulk institutional purchases.

Revenue estimates are based on:

  • Estimated prescriptions: 30 million annually globally by 2028.
  • Market share: 10% of corticosteroid prescriptions.
  • Average price: USD 35 per course.

Projected annual revenue:

Calculation Result
30 million prescriptions x 10% market share 3 million prescriptions
3 million x USD 35 per course USD 105 million

R&D and Geographic Expansion Strategies

CORTAN’s developer plans to invest around USD 50 million over three years for:

  • Phase IV post-marketing studies
  • Additional FDA and EMA indications
  • Expansion into emerging markets (China, India, Brazil)

Regulatory strategies include fast-track designations in the U.S. and orphan drug status for certain indications, reducing time-to-market.

Financial Trajectory

Based on projected prescriptions, market share, and pricing:

Year Prescriptions (millions) Estimated Revenue (USD millions)
2023 15 USD 52.5
2024 22 USD 77.0
2025 27 USD 94.5
2026 30 USD 105.0
2027 33 USD 115.5
2028 36 USD 126.0

Market growth, potential patent expiry of competitors, and successful global expansion could amplify these revenues beyond estimates.

Risks and Challenges

  • Patent expiration of key competitors (prednisone generics in 2025)
  • Regulatory delays or rejections in new markets
  • Pricing pressures from healthcare payers
  • Competition from biosimilars and new molecular entities

Key Takeaways

  • CORTAN has a solid regulatory foundation with patent protection until 2028.
  • The total corticosteroid market is projected to grow at 4.5% CAGR through 2030, with CORTAN capturing an estimated 8–12% of the market.
  • Revenue projections suggest a potential USD 126 million annual income by 2028, contingent upon prescription volume and market expansion.
  • Strategic investments aim to broaden indications and geographic reach.
  • Competitive landscape includes both branded and generic corticosteroids, emphasizing the importance of differentiating features.

FAQs

1. What are the primary indications for CORTAN?
Autoimmune conditions, asthma, allergic reactions, and dermatological inflammation.

2. When is patent expiry expected, and what are the implications?
Patent expires in 2028, after which generics could reduce pricing and affect revenues.

3. How does CORTAN compare pricing-wise to existing corticosteroids?
Initial pricing is set slightly above average for branded drugs, but market entry discounts are anticipated.

4. What regions are strategic for expansion?
Emerging markets such as China, India, and Brazil offer growth opportunities.

5. What competitive advantages does CORTAN possess?
Enhanced bioavailability and fewer side effects based on clinical data, aiming to increase prescriber adoption.


References

[1] Market Research Future. (2023). Corticosteroid Market Research Report.

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