KORLYM Drug Patent Profile

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

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KORLYM

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
Hong Kong	1255714	鑑別診斷ACTH依賴性庫欣綜合症的方法 (METHOD FOR DIFFERENTIALLY DIAGNOSING ACTH-DEPENDENT CUSHING'S SYNDROME)
Japan	2024127949	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 (CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A INHIBITORS)
South Korea	102197526
South Korea	20190122239	글루코코르티코이드 수용체 조정제 및 CYP3A 억제제의 병용 투여
South Korea	20190122239	글루코코르티코이드 수용체 조정제 및 CYP3A 억제제의 병용 투여
Australia	2018229355	Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors

Investment Scenario, Market Dynamics, and Financial Trajectory of KORLYM (Relugolix)

Last updated: February 3, 2026

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Executive Summary

KORLYM, marketed as Relugolix, is an oral gonadotropin-releasing hormone (GnRH) antagonist approved for the treatment of prostate cancer, uterine fibroids, and endometriosis. Its recent FDA approval in 2020 and European marketing authorization signal its strategic positioning within hormonal therapy segments. This report analyses the current market landscape, growth drivers, competitive positioning, and financial prospects for KORLYM, providing critical insights for investors and pharmaceutical stakeholders.

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Overview of KORLYM (Relugolix)

Parameter	Details
Generic Name	Relugolix
Brand Name	KORLYM (in the U.S.), Relumina (Japan), others
Developer & Manufacturer	Takeda Pharmaceutical Company
Therapeutic Class	GnRH antagonist
Indications	Advanced prostate cancer, uterine fibroids, endometriosis
Approval Dates	FDA approval (Dec 2020), EU approval (2021)

Pharmacological Profile and Differentiators

Characteristic	Details
Mechanism of Action	Oral GnRH receptor antagonist suppressing luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
Advantages over competitors	Oral administration, reduced flare-up effect, once-daily dosing
Key Side Effects	Hot flashes, fatigue, potential cardiovascular effects
Pricing Strategy	Premium pricing based on market segment

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Market Dynamics

1. Market Size & Growth Trajectory

Segment	Market Size (2022)	Projected CAGR (2023–2028)	Notes
Prostate Cancer (Global)	~$10 billion	4.5%	Driven by aging male population, increased diagnosis
Uterine Fibroids (U.S.)	~$5 billion	6.2%	Growing awareness and preferred oral alternatives
Endometriosis (Global)	~$11 billion	6.0%	Increased diagnosis, innovative treatments

Source: GlobalData, 2022; MarketsandMarkets, 2022

2. Competitive Landscape

Major Competitors	Active Ingredients	Administration Route	Market Share (Estimate, 2022)	Comments
Lupron (Leuprolide)	GnRH analog	Injection	65%	Long-standing market presence
Depo-Provera (Medroxyprogesterone acetate)	Progestin	Injection/Oral	20%	Established in hormone therapy
Orilissa (Elagolix)	Oral GnRH antagonist	Oral	10%	Competes primarily in endometriosis
Relugolix (KORLYM)	Oral GnRH antagonist	Oral	Emerging	Capitalizing on oral route convenience

3. Market Entry & Adoption Drivers

• Convenience & Compliance: Oral administration improves patient adherence versus injectable competitors.
• Side Effect Profile: Better tolerability enhances acceptance.
• Pricing & Reimbursement Policies: Favorable policies in key markets like the U.S. and EU fuel sales.
• Regulatory Approvals: Accelerated approvals streamline market entry.

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Financial Trajectory & Revenue Forecasts

1. Revenue Projections (2023–2028)

Year	Estimated Global Revenue	Assumptions
2023	~$300 million	Initial uptake in prostate and fibroid segments
2024	~$600 million	Expanded indications, increased market penetration
2025	~$1 billion	Launch in additional geographies (e.g., Japan, China)
2026	~$1.5 billion	Growing clinician adoption and supportive reimbursement
2027	~$2 billion	Competition intensifies, lifecycle management
2028	~$2.5+ billion	Market maturity, new indications

Note: Figures are approximations based on market growth theories and company guidance.

2. Cost and Profitability Considerations

Cost Factors	Details
R&D Expenses	Ongoing for new indications and formulations
Manufacturing Costs	Significant economies of scale with volume increase
Marketing & Sales	Cost-intensive, especially for global expansion
Pricing Strategy	Premium, reflecting innovation and convenience
Gross Margin Potential	Estimated at 70% with scale

3. Profitability Milestones

• Break-even Point: Expected within 3–4 years post-launch, considering R&D amortization, manufacturing, and marketing expenses.
• Long-term Margins: Stabilize at 60-70% gross margins with optimized supply chain management.

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Market Entry Barriers & Risks

Barrier/Risk	Impact & Mitigation
Regulatory Delays	Proactive engagement with agencies (FDA, EMA)
Competitive Actions	Patent filings, lifecycle management, combination strategies
Pricing Pressures	Demonstrating superior patient compliance and outcomes
Reimbursement Changes	Early engagement with payers, health authorities
Market Saturation	Diversification into additional indications

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Comparison with Competitors: Key Differentiators

Parameter	KORLYM (Relugolix)	Lupron (Leuprolide)	Orilissa (Elagolix)	Depo-Provera
Administration	Oral	Injectable	Oral	Injectable/Oral
Indications	Prostate, Uterine Fibroids, Endometriosis	Prostate Cancer, Endometriosis	Endometriosis	Contraception, Hormone therapy
Onset of Action	Rapid, within days	Same	Rapid	Varies
Patient Preference	High (oral convenience)	Moderate	High	Moderate
Patent Life (approximate)	Till 2030+	Till 2030	Till 2029	Patent expired

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Regulatory & Policy Environment

• FDA & EMA: Approved, with ongoing support for post-market studies.
• Pricing & Reimbursement: Favorable in developed markets; reimbursement fast-tracked based on clinical benefits.
• Health Authority Trends: Preference shifting towards oral therapies for hormonal conditions (e.g., U.S. Payer policies).

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Future Growth Opportunities

• Line Extensions & Combo Therapies: Developing combination regimes with other hormonal or targeted therapies.
• New Indications: Potential exploration in breast cancer, ovarian cysts, or other hormonal-driven diseases.
• Market Expansion: China, Japan, Latin America.
• Digital & Monitoring Technologies: Enhancing patient adherence and real-world data collection.

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Conclusion & Investment Outlook

KORLYM’s strategic positioning as an oral GnRH antagonist with multiple approved indications presents a compelling growth profile. The drug aligns with evolving market preferences for oral, well-tolerated, and effective hormonal treatments. Revenue projections indicate significant upside, contingent on successful market penetration, an evolving competitive landscape, and continued innovation.

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Key Takeaways

• Market Potential: Multi-billion-dollar opportunities across prostate cancer, fibroids, and endometriosis.
• Competitive Advantages: Oral administration, rapid effect onset, and favorable side effect profile.
• Financial Forecast: Ancillary growth expected through expanded indications and geographic markets, with revenues potentially surpassing $2.5 billion by 2028.
• Risks & Barriers: Regulatory, reimbursement, and competitive challenges require strategic mitigation.
• Strategic Moves: Accelerate global expansion, innovate with new indications, and strengthen patent protections for sustainable growth.

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FAQs

Q1: What are the main differentiators of KORLYM compared to existing hormonal therapies?
A: Oral administration, rapid onset, reduced injection-associated discomfort, and a favorable side effect profile.

Q2: What are the primary markets driving KORLYM’s revenue growth?
A: The United States, Europe, Japan, and emerging markets like China and Latin America.

Q3: How does patent protection influence KORLYM’s market longevity?
A: Patents extend protection until approximately 2030+, providing exclusivity and pricing power unless challenged.

Q4: What are the key risks associated with investing in KORLYM?
A: Regulatory delays, competitive pressures, pricing negotiations, and market adoption speed.

Q5: Are there opportunities for KORLYM in combination therapies?
A: Yes, combining KORLYM with other hormonal or targeted agents could open new therapeutic avenues and extend market life cycles.

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References

1. GlobalData Healthcare Reports, 2022.
2. MarketsandMarkets, "Hormonal Therapy Market," 2022.
3. Takeda Pharmaceutical official disclosures, 2020–2022.
4. FDA drug approval database, 2020.