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Last Updated: April 15, 2025

CORTIFOAM Drug Patent Profile


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When do Cortifoam patents expire, and when can generic versions of Cortifoam launch?

Cortifoam is a drug marketed by Viatris and is included in one NDA.

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

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Summary for CORTIFOAM
Drug patent expirations by year for CORTIFOAM
Drug Prices for CORTIFOAM

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Drug Sales Revenue Trends for CORTIFOAM

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Recent Clinical Trials for CORTIFOAM

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SponsorPhase
M.D. Anderson Cancer CenterPhase 3
National Cancer Institute (NCI)Phase 3

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Pharmacology for CORTIFOAM

US Patents and Regulatory Information for CORTIFOAM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Viatris CORTIFOAM hydrocortisone acetate AEROSOL, METERED;RECTAL 017351-001 Feb 10, 1982 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Cortifoam

Introduction

Cortifoam, a topical corticosteroid formulation of hydrocortisone acetate, is used primarily as adjunctive therapy for the treatment of ulcerative proctitis. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Overview

The global hydrocortisone market, which includes products like Cortifoam, is projected to grow significantly over the forecast period. Here are some key points:

  • Global Market Size: The hydrocortisone market was valued at US$ 1 billion and is expected to reach US$ 2 billion by 2028, growing at a CAGR of 4% during the forecast period[1].
  • Regional Dominance: North America accounts for a major share of the global hydrocortisone market, driven by the increasing cases of adrenocortical insufficiency and other indications[1].

Indications and Usage

Cortifoam is specifically indicated for the topical treatment of ulcerative proctitis, particularly in patients who cannot retain hydrocortisone or other corticosteroid enemas.

  • Therapeutic Use: It provides effective topical administration of an anti-inflammatory corticosteroid, with direct observations showing staining up to 10 centimeters into the rectum[2][4].

Route of Administration and Dosage

Cortifoam is administered rectally, typically one applicatorful (80mg hydrocortisone) once or twice daily for two to three weeks, followed by every other day thereafter[2][4].

Distribution Channels

The distribution of Cortifoam and similar hydrocortisone products occurs through various channels:

  • Hospital Pharmacies: A significant portion of the market is served through hospital pharmacies.
  • Retail Pharmacies: Retail pharmacies also play a crucial role in the distribution.
  • Online Pharmacies: Online pharmacies are increasingly important, especially for patients seeking convenience[1].

Financial Aspects

The financial trajectory of Cortifoam is influenced by several factors:

  • Pricing: The cost for Cortifoam 10% rectal foam with an applicator is around $471 for a supply of 15 grams, making it a relatively expensive treatment option. This price is for cash-paying customers and does not include insurance plans[5].
  • Market Value: The overall market value of hydrocortisone products, including Cortifoam, is expected to double by 2028, indicating a strong financial outlook[1].

Challenges and Opportunities

Several challenges and opportunities shape the market dynamics for Cortifoam:

  • Drug Shortages: The pharmaceutical market, including off-patent drugs like hydrocortisone, is susceptible to shortages due to price erosion and low-profit margins. This can impact the availability of Cortifoam[3].
  • Research and Development: Increased investment in research and development is driving the growth of the hydrocortisone market. New formulations and indications could further boost the market[1].

Competitive Landscape

The competitive landscape for Cortifoam is characterized by:

  • Brand Name Dominance: Cortifoam is currently available only as a brand name drug, with no generic version available. This can affect pricing and market competition[5].
  • Regional Market Attractiveness: Different regions have varying levels of market attractiveness based on indications, routes of administration, and distribution channels. North America remains a key market[1].

Regulatory and Safety Considerations

Cortifoam has several regulatory and safety considerations:

  • Contraindications: It is contraindicated in patients with certain conditions such as obstruction, abscess, perforation, and peritonitis. It also has various warnings and precautions related to its use[2][4].
  • Adverse Reactions: The drug can cause a range of adverse reactions, including hypertension, fluid retention, adrenal suppression, and others[4].

Patient Assistance and Pricing Strategies

To make Cortifoam more accessible, various patient assistance programs are available:

  • Discount Cards: Programs like the Drugs.com Discount Card can save patients up to 80% on the cost of Cortifoam and other prescription medicines[5].

Future Outlook

The future outlook for Cortifoam is positive, driven by the growing demand for hydrocortisone products and the expanding therapeutic applications.

  • Market Growth: The hydrocortisone market is expected to continue growing, driven by increasing cases of adrenocortical insufficiency and other indications[1].
  • Innovation: Continued innovation in formulations and delivery methods could further enhance the market position of Cortifoam and similar products.

Key Takeaways

  • The global hydrocortisone market, including Cortifoam, is projected to grow at a CAGR of 4% until 2028.
  • North America dominates the market due to high demand and increasing cases of related conditions.
  • Cortifoam is specifically used for ulcerative proctitis and is administered rectally.
  • The drug faces challenges such as potential shortages and high pricing but benefits from patient assistance programs.
  • The market is driven by research and development investments and the need for effective treatments for various indications.

FAQs

Q: What is Cortifoam used for? A: Cortifoam is used as adjunctive therapy for the topical treatment of ulcerative proctitis, particularly in patients who cannot retain hydrocortisone or other corticosteroid enemas.

Q: How is Cortifoam administered? A: Cortifoam is administered rectally, typically one applicatorful (80mg hydrocortisone) once or twice daily for two to three weeks, followed by every other day thereafter.

Q: What are the common distribution channels for Cortifoam? A: Cortifoam is distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

Q: Why is Cortifoam expensive? A: The cost for Cortifoam 10% rectal foam with an applicator is around $471 for a supply of 15 grams, making it relatively expensive due to its brand name status and lack of generic alternatives.

Q: What are the potential side effects of Cortifoam? A: Cortifoam can cause a range of adverse reactions, including hypertension, fluid retention, adrenal suppression, and others.

Sources

  1. Transparency Market Research - Hydrocortisone Market | Global Industry Report, 2028
  2. FDA - Cortifoam® (hydrocortisone acetate 10%) IN-683015-0X Rx
  3. Office of Health Economics - The Dynamics of Drug Shortages
  4. eMPR - CORTIFOAM Prescription & Dosage Information
  5. Drugs.com - Cortifoam Prices, Coupons, Copay Cards & Patient Assistance

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