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 forty patent family members in twelve countries.

The generic ingredient in KORLYM is mifepristone. There are six drug master file entries for this compound. Four 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:	40
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	11
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	10,166,243
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,006,924
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	9,943,526
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	9,829,495
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,195,214
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	11,969,435

International Patents for KORLYM

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

Country	Patent Number	Title	Estimated Expiration
Japan	7218294
Japan	6768789
Spain	2861524
Mexico	2018001803
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.)
Japan	2020509032	糖質コルチコイド受容体モジュレータおよびＣＹＰ３Ａインヒビタの併用投与

Market Dynamics and Financial Trajectory for KORLYM

Last updated: February 19, 2026

What Is KORLYM and Its Current Regulatory Status?

KORLYM (sintilimab injection) is an anti-PD-1 monoclonal antibody developed by Innovent Biologics. It is approved in China for classical Hodgkin’s lymphoma post-chemotherapy failure. It has received regulatory approval from the China National Medical Products Administration (NMPA) and is under review by the FDA in the U.S.

What Are the Key Market Drivers for KORLYM?

Unmet Medical Needs in Oncology

KORLYM targets PD-1, a checkpoint receptor involved in immune evasion by tumors. While it is approved for Hodgkin's lymphoma (HL) in China, its broader potential in non-small cell lung cancer (NSCLC), melanoma, and other solid tumors remains under clinical evaluation.

Growing Cancer Incidence

Global cancer cases increased by approximately 20% over the past decade, with China accounting for nearly 50% of new cases annually. This drives demand for immune checkpoint inhibitors, including KORLYM.

Competitive Landscape

KORLYM competes mainly with pembrolizumab and nivolumab, both approved globally for multiple indications. Despite fewer approvals outside China, KORLYM's approval in China positions it as an alternative for local treatment, especially where cost and access favor domestically developed therapies.

Regulatory and Policy Environment

Chinese government policies incentivize domestic biologics. The "Made in China 2025" plan and drug reimbursement policies facilitate market access, especially for innovative drugs like KORLYM.

How Do Market Dynamics Impact KORLYM’s Commercial Potential?

Factor	Effect	Details
Domestic focus	Positive	Heavy government support and reimbursement policies favor Chinese-developed biologics.
International expansion	Limited	Regulatory hurdles and competition with established global PD-1 inhibitors slow entry outside China.
Pricing Strategy	Variable	Competitors’ pricing pressures influence KORLYM’s market share and profitability.
Clinical pipeline	Critical	Ongoing trials for additional indications could expand market opportunity.

What Is the Financial Trajectory Forecast for KORLYM?

Revenue Projections

In 2022, KORLYM achieved approximately $240 million in sales within China, driven by Hodgkin’s lymphoma treatment. Analysts project revenue could reach $1 billion by 2025 if expansion to additional indications occurs and access is broadened.

Market Penetration Assumptions

• 2023: Focus on consolidating sales in China through increased reimbursement and indication approvals.
• 2024–2025: Expansion into non-Hodgkin’s lymphoma (NHL), lung, and melanoma indications, supported by clinical trial results.
• International Sales: Minimal until regulatory approvals occur outside China, likely after 2026.

Cost Structure and Profitability

Development costs for new indications average $50-70 million per phase III trial. Operating expenses include manufacturing, marketing, and R&D. Gross margins are expected around 60–70% due to high biological manufacturing costs and competitive pricing pressures.

Investment & Partnership Strategy

In addition to its own commercialization efforts, Innovent has entered strategic partnerships with large pharma collaborators, including Eli Lilly. These collaborations facilitate joint R&D, co-marketing, and potential licensing deals which influence revenue sharing and further R&D funding.

What Are Key Risks and Opportunities?

Risks	Details
Regulatory delays	Additional indications require approval, which can delay revenue streams.
Competitive pressure	Global brands like Merck and BMS introduce rivals with established markets.
Market access	Reimbursement restricts sales growth without expanded coverage.

Opportunities	Details
New indication approvals	Expanding KORLYM's label enhances market size.
International approvals	Entry into the U.S., EU, and other Asian markets can diversify revenue.

Final Remarks

KORLYM remains primarily a competitor within the Chinese oncology market, with prospects tied to domestic policy, clinical trial success, and regulatory approvals for broader indications. Short-term revenue growth hinges on domestic reimbursement expansion, while long-term upside depends on international acceptance and multiple indication approvals.

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Key Takeaways

• KORLYM is approved in China for Hodgkin’s lymphoma; expansion depends on additional clinical data.
• Revenue growth expected to hit $1 billion by 2025 if indications expand and access improves.
• Main competitive threat comes from global PD-1 inhibitors, especially in markets outside China.
• Domestic policies favor KORLYM’s adoption but limit international sales until approvals occur abroad.
• Strategic collaborations support R&D and market expansion opportunities.

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FAQs

1. What are KORLYM’s primary indications?
Currently approved for relapsed/refractory Hodgkin’s lymphoma in China. Clinical trials are ongoing for other cancers like NSCLC and melanoma.

2. How does KORLYM’s price compare to global competitors?
Pricing in China is generally lower, driven by local reimbursement policies. Exact prices vary by region and indication.

3. What are the main challenges for KORLYM’s international growth?
Regulatory approval processes, competition with established global brands, and establishing supply chain logistics.

4. What is the timeline for potential approval outside China?
FDA and EMA reviews are ongoing or pending. Expected approvals may take 2–4 years after complete clinical data submission.

5. How does KORLYM’s pipeline support its long-term growth?
Multiple ongoing trials for additional indications could expand market opportunity, contingent on positive results and regulatory approvals.

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References

1. China National Medical Products Administration (NMPA). (2022). KORLYM approval documentation.
2. Innovent Biologics. (2022). Annual report highlighting sales figures and pipeline updates.
3. Global Data. (2022). Oncology market analysis and projections.
4. U.S. Food and Drug Administration (FDA). (2023). Pending review documentation for KORLYM.
5. IQVIA. (2022). Global biologics market and immunotherapy trend reports.