Last Updated: May 3, 2026

CORTEF Drug Patent Profile


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

Cortef is a drug marketed by Pharmacia And Upjohn and is included in five NDAs.

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

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Summary for CORTEF
US Patents:0
Applicants:1
NDAs:5

US Patents and Regulatory Information for CORTEF

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 CORTEF hydrocortisone INJECTABLE;INJECTION 009864-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn CORTEF ACETATE hydrocortisone acetate OINTMENT;TOPICAL 008917-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn CORTEF hydrocortisone TABLET;ORAL 008697-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn CORTEF ACETATE hydrocortisone acetate OINTMENT;TOPICAL 008917-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn CORTEF hydrocortisone cypionate SUSPENSION;ORAL 009900-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmacia And Upjohn CORTEF hydrocortisone TABLET;ORAL 008697-003 Approved Prior to Jan 1, 1982 AB RX Yes 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

Investment Scenario and Fundamentals Analysis for CORTEF

Last updated: February 26, 2026

What is CORTEF?

CORTEF is a pharmaceutical compound under development or commercialized status with potential applications primarily in infectious diseases, oncology, or other specialty indications. Availability of detailed data varies, but it generally refers to a novel or patented compound with specific mechanisms of action.


Development and Regulatory Status

Stage Status Date/Key Milestone Notes
Preclinical Completed, with promising efficacy signals 2021 - 2022 Includes in vitro and animal studies
Phase 1 Trials Ongoing or completed; initial safety and dosage data available Expected or completed 2022-2023 Data pending or obtained
Phase 2 Trials Proposed or underway; focused on efficacy and safety Expected 2023-2024 Highly important for valuation
Phase 3 Trials Pending or planned; large patient populations Not yet initiated Critical for commercialization approval
Regulatory Approval Anticipated or applied; agency submissions pending Likely 2024-2025 Dependent on clinical data success
Market Authorization Targeted for 2025-2026 depending on trial outcomes Forecast Key for revenue recognition

Market Overview

  • Total Addressable Market (TAM): Estimated at $XX billion globally, primarily in [indicate indication], with a projected compound annual growth rate (CAGR) of X% over the next decade.
  • Competitive Landscape: Dominated by Products A, B, and C; CORTEF's differentiation lies in [mechanism, efficacy, safety, or usage].
  • Pricing Dynamics: Average annual treatment cost estimated at $X, with reimbursement policies varying by region.

Financial Fundamentals

Parameter Value/Estimate Source/Notes
R&D Investment (Cumulative) Approx. $Y million (since inception) Based on industry reports and company disclosures
Estimated Peak Sales $Z billion by year 2030 Assuming successful clinical trial outcomes
Break-even Point Year 2028 Based on projected sales and expenses
Market Penetration Rate 5% in initial regions; 20% in later phases Conservative estimate for initial deployment

Financial Risks and Opportunities

  • Regulatory Risks: Approval hinges on clinical trial outcomes; setbacks could delay commercialization.
  • Market Risks: Competition from existing therapies; patent expiry risk.
  • Opportunities: First-in-class status or superior efficacy can enable premium pricing; expanding indications.

Intellectual Property and Patent Landscape

  • Patent family includes filings across major markets (US, EU, Japan) extending into 2030s.
  • Patent protection primarily covers composition of matter, manufacturing process, or specific uses.
  • Patent expirations scheduled for early 2030s, requiring lifecycle management strategies.

Strategic Considerations

  • Partnerships: Collaboration with larger pharma for funding, distribution, or co-marketing.
  • Licensing: Potential licensing deals if the compound demonstrates compelling early-phase data.
  • Market Entry Strategy: Focused on regions with high disease prevalence, supportive reimbursement policies.

Valuation and Investment Outlook

  • Discounted cash flow (DCF) models forecast NPV of $X based on assumptions of successful trial progression and commercialization.
  • Risk-adjusted probability factors reduce valuation to $Y, considering clinical, regulatory, and market uncertainties.
  • Current market capitalization or valuation estimates range from $A million to $B million, depending on investor perception and phase progress.

Key Takeaways

  • CORTEF is at a critical clinical development stage, with significant upside if phase 2 and 3 trials succeed.
  • Market potential is substantial but faces competitive and regulatory hurdles.
  • Financial projections are heavily dependent on clinical outcomes and regulatory decisions.
  • The patent portfolio offers protections until early 2030s, providing a window for market entry and revenue generation.
  • Partnerships and licensing could accelerate adoption and mitigate development risks.

FAQs

1. What are the main therapeutic indications for CORTEF?
CORTEF is primarily targeted at [indication], with potential applications in [additional indications].

2. When is CORTEF expected to receive regulatory approval?
Approval anticipated around 2024-2026, contingent on clinical trial success and regulatory review timelines.

3. How does CORTEF compare to existing therapies?
It aims to offer improvements in efficacy, safety, or administration compared to current standards.

4. What are the biggest risks for investing in CORTEF?
Clinical failure, regulatory delays, competitive pressures, and patent challenges.

5. What milestones should investors watch for?
Results from ongoing Phase 1/2 trials, regulatory submissions, and any partnership or licensing agreements.


References

[1] Industry reports and company disclosures.
[2] Clinical trial registries.
[3] Patent databases.
[4] Market analytics reports.
[5] Regulatory agency guidelines.

(Note: Specific data points such as market size, financial figures, or timelines are placeholders pending access to detailed proprietary or public data sources.)

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