KORLYM Drug Patent Profile

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

Korlym is a drug marketed by Corcept Therap and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in twelve countries.

The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mifepristone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Korlym

A generic version of KORLYM was approved as mifepristone by GENBIOPRO on April 11^th, 2019.

Summary for KORLYM

International Patents:	39
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	11
Patent Applications:	4,965
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KORLYM
What excipients (inactive ingredients) are in KORLYM?	KORLYM excipients list
DailyMed Link:	KORLYM at DailyMed

Recent Clinical Trials for KORLYM

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

Sponsor	Phase
Corcept Therapeutics	Phase 4
Charles Drew University of Medicine and Science	Phase 2
Johns Hopkins University	N/A

See all KORLYM clinical trials

Pharmacology for KORLYM

Drug Class	Progestin Antagonist
Mechanism of Action	Progestational Hormone Receptor Antagonists

Paragraph IV (Patent) Challenges for KORLYM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KORLYM	Tablets	mifepristone	300 mg	202107	1	2017-12-15

US Patents and Regulatory Information for KORLYM

KORLYM is protected by eighteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes

International Patents for KORLYM

See the table below for patents covering KORLYM around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017027851
Mexico	2018001803	METODO PARA DISGNOSTICAR DE MANERA DIFERENCIAL EL SINDROME DE CUSHING DEPENDIENTE DE LA CORTICOTROPINA. (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME.)
European Patent Office	3335043	PROCÉDÉ PERMETTANT D'ÉTABLIR UN DIAGNOSTIC DIFFÉRENTIEL DU SYNDROME DE CUSHING EN FONCTION DE L'HORMONE ADRÉNOCORTICOTROPE (ACTH) (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME)
South Korea	20180052120	ACTH-의존성 쿠싱 증후군을 감별 진단하는 방법
Japan	7218294

KORLYM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Korlym

Introduction to Korlym

Korlym, developed by Corcept Therapeutics, is a drug that has transformed the landscape of treating Cushing’s syndrome, a rare endocrine disorder. Initially approved by the FDA in 2012 as an orphan drug, Korlym has become a cornerstone in Corcept's portfolio, driving significant revenue and growth.

Orphan Drug Designation and Market Exclusivity

The orphan drug designation for Korlym provided Corcept with seven years of market exclusivity and various economic incentives. This designation is crucial as it encourages the development of medicines for rare diseases affecting fewer than 200,000 patients in the U.S.[1].

Pricing Strategy and Revenue Growth

Since its approval, Korlym's price has increased substantially. The drug's average wholesale price rose from $223.20 per pill in 2012 to $549.60 by December 2017, before any discounts or rebates. This pricing strategy has contributed to Corcept's revenue growth, with the company's revenue nearly doubling to $159.2 million in 2017[1].

Financial Performance

In recent years, Corcept has continued to experience robust financial growth driven by Korlym. Here are some key financial highlights:

• First Quarter 2024: Revenue increased by 39% to $146.8 million compared to the same period in 2023. The company also raised its 2024 revenue guidance to $620-$650 million[2].
• Third Quarter 2024: Revenue surged by 48% to $182.5 million, with the company increasing its 2024 revenue guidance again to $675-$700 million[5].
• Annual Revenue: For the full year 2022, Corcept's revenue was $401.9 million, and the company remains optimistic about future growth, especially with the expansion of its patient and prescriber base[4].

Market Penetration and Patient Base

The increasing awareness and treatment rates of hypercortisolism and Cushing's syndrome have been critical drivers of Korlym's success. Corcept has successfully expanded the number of patients and physicians engaged with Korlym, leading to a record number of new prescribers and patients in the first quarter of 2024[2].

Clinical Development and Pipeline

Corcept's financial health, supported by a strong cash and investment position, enables significant investments in research and development. The company is advancing several clinical development programs, including relacorilant, dazucorilant, and miricorilant, which are selective cortisol modulators. The positive results from the Phase 3 GRADIENT trial and the upcoming NDA submission for relacorilant are promising indicators of future growth[5].

Competitive Landscape and Generic Threats

Despite the success of Korlym, Corcept faces potential competition from generic versions. Teva Pharmaceutical Industries filed an application for a generic version of Korlym, but Corcept's executives are confident in their ability to manage this challenge through litigation, which they can afford given their financial position[1].

Financial Health and Investor Confidence

Corcept's strong financial health is evident from its cash and investment reserves, which stood at $547.6 million as of September 30, 2024. The company has also initiated a $200 million stock repurchase program, signaling confidence in its valuation and future prospects[3].

Support Services and Patient Care

Corcept's extensive system of support services is crucial for optimizing the benefits of Korlym for patients. This infrastructure, developed and refined over many years, helps create a life-changing impact for patients receiving Korlym treatment[5].

Future Outlook

The company's guidance for the next year suggests robust market penetration and possibly an expansion of indications or increased market share. With increasing awareness of hypercortisolism and Cushing's syndrome, Corcept is well-positioned to continue its growth trajectory.

"Physicians are increasingly aware that hypercortisolism is much more prevalent than was previously assumed, so they are screening more patients for the disorder," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer[2].

Key Takeaways

• Revenue Growth: Korlym has driven significant revenue growth for Corcept, with a 39% increase in the first quarter of 2024 and a 48% increase in the third quarter.
• Pricing Strategy: The drug's price has increased substantially since its approval, contributing to revenue growth.
• Market Penetration: Increasing awareness and treatment rates of hypercortisolism and Cushing's syndrome have expanded the patient and prescriber base.
• Clinical Development: Corcept is advancing several clinical development programs, including relacorilant, which shows promising results.
• Financial Health: The company has a strong cash and investment position, enabling significant investments in research and development.

FAQs

1. What is Korlym used for?

   • Korlym is used to treat Cushing’s syndrome, a rare endocrine disorder caused by excessive levels of cortisol.

2. How did Korlym achieve market exclusivity?

   • Korlym was designated as an orphan drug by the FDA, providing Corcept with seven years of market exclusivity and other economic incentives.

3. Why has Korlym's price increased significantly?

   • The price increase is part of Corcept's pricing strategy, which has contributed to the company's revenue growth. The drug's high price is also justified by its orphan drug status and the limited patient base.

4. What are the key drivers of Korlym's success?

   • The increasing awareness and treatment rates of hypercortisolism and Cushing's syndrome, along with Corcept's extensive support services, have been critical drivers of Korlym's success.

5. How is Corcept addressing the threat of generic versions of Korlym?

   • Corcept is managing the threat through litigation, which they can afford given their strong financial position.

Sources

1. KFF Health News - How A Drugmaker Turned The Abortion Pill Into A Rare-Disease Profit Machine
2. BioSpace - Corcept Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update
3. StockTitan - Corcept Therapeutics Provides Financial Update and Announces Stock
4. Corcept Therapeutics IR - Corcept Therapeutics Announces Fourth Quarter and Full-Year 2022 Financial Results
5. Corcept Therapeutics IR - Corcept Therapeutics Announces Third Quarter Financial Results, Positive Results From Phase 3 GRADIENT Trial in Patients With Cushing’s Syndrome and Provides Corporate Update