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Last Updated: December 22, 2024

CORT-DOME Drug Patent Profile


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When do Cort-dome patents expire, and what generic alternatives are available?

Cort-dome is a drug marketed by Bayer Pharms and is included in two NDAs.

The generic ingredient in CORT-DOME 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 Cort-dome

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

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Summary for CORT-DOME
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 109
Patent Applications: 4,486
DailyMed Link:CORT-DOME at DailyMed
Drug patent expirations by year for CORT-DOME

US Patents and Regulatory Information for CORT-DOME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Pharms CORT-DOME hydrocortisone CREAM;TOPICAL 009585-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Pharms CORT-DOME hydrocortisone LOTION;TOPICAL 009895-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Pharms CORT-DOME hydrocortisone CREAM;TOPICAL 009585-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Pharms CORT-DOME hydrocortisone LOTION;TOPICAL 009895-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 CORT-DOME

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/002185
Treatment of adrenal insufficiency in adults.
Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416
Replacement 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/005105
Treatment 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

CORT-DOME Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Corcept Therapeutics (CORT)

Introduction

Corcept Therapeutics Incorporated (CORT), a pharmaceutical company, has been making significant strides in the healthcare industry, particularly with its flagship product, Korlym® (mifepristone), and a robust pipeline of innovative treatments. Here, we will delve into the market dynamics and financial trajectory of Corcept Therapeutics, highlighting key aspects of its marketing mix, financial performance, and future outlook.

Marketing Mix: Product

Innovative Treatments

Corcept Therapeutics is known for its innovative approach to treating rare endocrine disorders. The company's primary product, Korlym®, is an FDA-approved medication for the treatment of hypercortisolism in patients with Cushing's syndrome who have failed surgery or are not candidates for surgery. Recently, Corcept launched an authorized generic version of Korlym®, enhancing patient accessibility and support[1].

Robust Pipeline

Corcept's pipeline includes over 1,000 compounds, with a focus on selective cortisol modulators. Notable pipeline candidates include relacorilant, which has shown positive results in the GRACE trial for Cushing's syndrome, and other late-stage trials such as ROSELLA for ovarian cancer and DAZALS for ALS[2].

Marketing Mix: Place

Specialty Pharmacy Distribution

Corcept distributes Korlym® primarily through Optime, a specialty pharmacy. This focused distribution strategy allows for better management of the complexities associated with the drug, including patient education and support. The national distribution across the United States ensures that patients have access to necessary treatments regardless of their location[1].

Logistical Support

The company engages specialty distributors to streamline logistical operations, ensuring efficient delivery and inventory management. This partnership is crucial for maintaining the integrity of the supply chain, particularly for sensitive pharmaceutical products[1].

Marketing Mix: Promotion

Physician and Patient Support

Corcept has implemented a unique system of patient and physician support since the launch of Korlym®. This includes multiple refinements over the past 12 years, which have been critical in educating healthcare providers and patients about hypercortisolism and its treatment. The increasing awareness among physicians has led to a record number of new Korlym® prescribers and patients receiving the treatment[2].

Clinical Trials and Research

The company's promotional efforts are also supported by positive results from clinical trials. For example, the GRACE trial for relacorilant and the CATALYST study have highlighted the prevalence and treatment options for hypercortisolism, further educating the medical community[2].

Marketing Mix: Price

Revenue Growth

Corcept Therapeutics has reported significant revenue growth. In the third quarter of 2024, the company achieved a net product revenue of $182.5 million, an increase from $123.6 million in the same quarter of 2023. For the nine months ended September 30, 2024, the total revenue reached $493.2 million, compared to $347.0 million in 2023[1].

Price Adjustments

A price increase effective January 1, 2024, contributed to the overall revenue growth. This strategic move reflects the company's efforts to align pricing with the perceived value of its products while navigating market conditions[1].

Cost of Sales

The cost of sales for Corcept was reported at 1.6% of revenue for both the three and nine months ended September 30, 2024, indicating an efficient production process. The cost of sales amounted to $2.9 million for the third quarter and $7.9 million for the nine-month period[1].

Financial Performance

Quarterly and Annual Revenue

Corcept Therapeutics reported strong financial results for Q2 2024, with revenue of $163.8 million, a 39% increase year-over-year. The company raised its 2024 revenue guidance to $640–$670 million. Net income per share was $0.32, up from $0.25 in Q2 2023[2].

Cash and Investments

As of June 30, 2024, Corcept's cash and investments stood at $492.5 million, providing a solid financial foundation for ongoing operations and future investments[2].

Competitive Landscape

Pricing Pressure

Corcept faces competitive pricing pressure from generic drugs entering the market. This competition affects pricing strategies and may necessitate adjustments to maintain market share and profitability[1].

Future Outlook

Pipeline Progress

The progress in Corcept's clinical development pipeline, including positive results from the GRACE trial and the CATALYST study, positions the company for future success. The planned submission of a New Drug Application for relacorilant in Q4 2024 and expected results from other late-stage trials are key milestones[2].

Market Expansion

The increasing awareness of hypercortisolism among physicians and the growing need for effective treatments in rare endocrine disorders are expected to drive market expansion. Corcept's strategic distribution and promotional efforts ensure that healthcare providers and patients are well-informed and supported, further solidifying the company's market position[1][2].

Key Takeaways

  • Innovative Products: Corcept Therapeutics focuses on innovative treatments, including Korlym® and a robust pipeline of selective cortisol modulators.
  • Effective Distribution: The company uses specialty pharmacies and distributors to ensure efficient and comprehensive distribution.
  • Strong Financial Performance: Corcept has reported significant revenue growth and maintains a solid financial position.
  • Competitive Pricing: The company faces competitive pricing pressure but has adjusted its pricing strategy to align with the perceived value of its products.
  • Future Growth: Positive pipeline progress and increasing market awareness are expected to drive future growth.

Frequently Asked Questions (FAQs)

What is Korlym®, and how is it distributed?

Korlym® (mifepristone) is an FDA-approved medication for the treatment of hypercortisolism in patients with Cushing's syndrome. It is primarily distributed through Optime, a specialty pharmacy, ensuring comprehensive national coverage and patient support[1].

What is the current financial performance of Corcept Therapeutics?

Corcept Therapeutics reported a net product revenue of $182.5 million for Q3 2024, with total revenue for the nine months ended September 30, 2024, reaching $493.2 million. The company has also raised its 2024 revenue guidance to $640–$670 million[1][2].

What are the key pipeline candidates for Corcept Therapeutics?

Key pipeline candidates include relacorilant, which has shown positive results in the GRACE trial for Cushing's syndrome, and other late-stage trials such as ROSELLA for ovarian cancer and DAZALS for ALS[2].

How does Corcept Therapeutics manage competitive pricing pressure?

Corcept adjusts its pricing strategy to align with the perceived value of its products while navigating market conditions. Despite competitive pressure from generic drugs, the company has implemented price increases to maintain profitability[1].

What are the future growth prospects for Corcept Therapeutics?

The company's future growth is expected to be driven by positive pipeline progress, including the planned submission of a New Drug Application for relacorilant and expected results from other late-stage trials. Increasing market awareness of hypercortisolism and the need for effective treatments also support future growth[2].

Cited Sources:

  1. Marketing Mix Analysis of Corcept Therapeutics Incorporated (CORT) - DCF FM
  2. Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update - Stock Titan
  3. Do Drug Courts Work? Findings From Drug Court Research - NIJ (Not directly relevant but included for completeness)
  4. Global Inhalable Drugs Market to Register Incremental Growth at a CAGR of ~6% by 2030 - Globe Newswire (Not directly relevant but included for completeness)
  5. Corcept Therapeutics (CORT) Earnings Date and Reports 2025 - Market Beat

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