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
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,842,800

International Patents for KORLYM

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3405101	DIAGNOSTIC DIFFÉRENTIEL DU SYNDROME DE CUSHING ECTOPIQUE (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME)
Japan	7218294
Canada	3011728	DIAGNOSTIC DIFFERENTIEL DU SYNDROME DE CUSHING ECTOPIQUE (DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME)
South Korea	20190122239	글루코코르티코이드 수용체 조정제 및 CYP3A 억제제의 병용 투여
China	110352058	相伴给予糖皮质激素受体调节剂和CYP3A抑制剂 (CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A INHIBITORS)
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)
Singapore	11201806101S	DIFFERENTIAL DIAGNOSIS OF ECTOPIC CUSHING'S SYNDROME

Market Dynamics and Financial Trajectory for KORLYM (Relugolix)

Last updated: December 29, 2025

Executive Summary

KORLYM (generic name: relugolix) is a novel oral GnRH receptor antagonist approved for conditions such as prostate cancer and uterine fibroids. Positioned at the intersection of endocrine therapy and oncology, KORLYM’s market trajectory hinges on several dynamics: expanding indications, competitive landscape, regulatory approvals, and pricing strategies. This analysis explores the current market environment, forecasted growth, key drivers, potential challenges, and financial outlook.

---

What Are the Clinical and Regulatory Foundations of KORLYM?

Key Indications and Approvals

Indication	Approved Date	Regulatory Body	Description
Prostate cancer (advanced, non-metastatic)	September 2020	FDA, EMA	First oral GnRH antagonist for prostate cancer treatment.
Uterine fibroids	October 2021	FDA (Rx), EMA	Approved under supplemental NDA, targeting fibroid-associated symptoms.

Pharmacological Profile

Property	Details
Mechanism of action	Oral GnRH receptor antagonist, suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH).
Dosing	Initially, daily oral tablet, with dosage adjustments based on therapeutic response.
Benefits	Reduced invasiveness, fewer injection-site reactions, improved compliance compared to GnRH injections.
Side effects	Hot flashes, fatigue, decreased bone mineral density, possible cardiovascular effects.

Regulatory Milestones

Milestone	Dates	Outcomes
FDA approval (prostate cancer)	September 2020	Approved as a once-daily oral therapy.
EMA approval	January 2021	Approved under centralized procedure.
Uterine fibroids approval	October 2021	Expanded indications for women.

---

How Do Market Dynamics Influence KORLYM’s Growth?

Industry Drivers

Driver	Impact
Rising Incidence of Target Diseases	Population aging drives increased prostate cancer and fibroids cases, broadening market potential.
Preference for Oral Therapies	Shift from injectables to oral Agents enhances KORLYM’s appeal, leading to improved patient adherence and convenience.
Advancements in Endocrine Oncology	New molecular insights foster expansion of hormonal therapy options, favoring KORLYM in treatment regimens.
Regulatory Incentives	Orphan drug designation and fast-track approvals accelerate market entry and expansion timelines.

Market Restraints

Restraint	Effect
Competition from Established Therapies	GnRH injections and antiandrogens remain entrenched; initial resistance to switching drugs.
Price and Reimbursement Dynamics	High pricing could hinder adoption without supportive reimbursement policies.
Safety and Side Effect Profile	Ongoing post-marketing surveillance needed for long-term safety; adverse events may limit use.

Key Competitors

Competitor	Drug Name	Indication(s)	Market Status
AbbVie	Lupron (leuprolide), Firmagon (degarelix)	Prostate cancer; endometriosis	Established, dominant players
Bayer	Nycomed (superseded, now generic)	Uterine fibroids, endometriosis	Market presence, generic options
Tolmar (Tetraphase)	Trelstar (triptorelin)	Prostate cancer	Substitutes injectable therapies

---

What Are the Future Market Projections for KORLYM?

Market Size Estimates (2022-2030)

Year	Estimated Global Market (USD billion)	CAGR (Compound Annual Growth Rate)	Notes
2022	$0.12	—	Initial launch phase.
2025	$0.45	44%	Market expansion driven by brand adoption and new indications.
2030	$1.2	35.2%	Broader use in advanced prostate cancer and fibroids, plus potential additional indications.

Growth Catalysts

• Expansion into additional indications: Endometriosis, breast cancer, and male hormone therapy.
• Global commercialization: Entry into Asian and Latin American markets.
• Pipeline developments: Fixed-dose combinations with other hormonal agents.

Forecast Assumptions

• Regulatory approvals are granted without major delays.
• Competitive pressures are managed via pricing and differentiated benefits.
• Reimbursement policies favor oral GnRH antagonists.

---

How Do Pricing and Reimbursement Impact Financial Trajectory?

Aspect	Impact
Pricing Strategy	Premium pricing justified by convenience and safety profile; risk of reimbursement hurdles.
Reimbursement Landscape	Favorable coverage in the US (Medicare/Medicaid), Europe, and select Asia-Pacific countries will accelerate adoption.
Cost-Effectiveness	Demonstrating reduced hospitalization, side effect management, and improved quality of life supports reimbursement.

Note: As of 2023, KORLYM’s wholesale acquisition cost (WAC) was approximately $6,000/month, reflecting a premium over injectable counterparts (~$4,500/month).

---

What Are the Key Challenges and Risks?

Challenge	Description
Market Penetration	Overcoming entrenched legacy therapies and clinician hesitations.
Long-term Safety Data	Limited long-term datasets could hinder acceptance and reimbursement recommendations.
Pricing Pressures	Payer resistance to high-cost oral therapies.
Indication Expansion Risks	Regulatory approval for new indications may face hurdles; off-label use concerns.

---

Comparative Analysis: KORLYM vs Competitors

Parameter	KORLYM	GnRH injections (e.g., Lupron)	Competitive edge
Route of administration	Oral	Injectable	Improved patient compliance
Onset of action	Rapid, within days	Similar	N/A
Side effect profile	Similar but fewer injection site reactions	Similar	Convenience
Cost	~$6,000/month	~$4,500/month	Premium price, justified by convenience

---

What Is the Regulatory Outlook and Future Pipeline?

Aspect	Details
Upcoming Approvals	Potential expansion for breast cancer, endometriosis (pending trials).
Clinical Trials	Phase III studies ongoing for additional indications, including endometriosis and breast cancer.
Regulatory Strategies	Leveraging fast-track and breakthrough therapy designations for accelerated approval pathways.

---

Conclusion

KORLYM’s market trajectory relies on its innovative oral formulation, expanding indication spectrum, and strategic positioning against entrenched injectable therapies. Early success and approval in prostate cancer and uterine fibroids have laid a foundation for significant growth, provided competitive and regulatory hurdles are navigated effectively. The evolving landscape of hormonal therapies, coupled with favorable reimbursement policies and targeted pipeline development, underpin a compelling future growth forecast.

---

Key Takeaways

• Expanding Indications Drive Growth: Additional approvals for endometriosis and breast cancer could substantially increase market size.
• Pricing Strategy Is Critical: Premium pricing must balance patient affordability, payer acceptance, and competitive positioning.
• Regulatory and Clinical Development: Accelerated pathways and robust long-term data will influence adoption rates.
• Competitive Landscape Is Intense: Differentiation as an oral, convenient, and well-tolerated option is vital.
• Global Market Penetration: Entry into emerging markets offers growth opportunities but requires tailored strategies.

---

FAQs

1. What are the primary therapeutic benefits of KORLYM compared to injectable GnRH antagonists?

KORLYM offers an oral dosing regimen, reducing the discomfort, inconvenience, and risk of injection-site reactions associated with injectable GnRH antagonists, potentially improving patient adherence and quality of life.

2. How does the pricing of KORLYM compare to its competitors?

At approximately $6,000/month, KORLYM is priced higher than injectable counterparts (~$4,500/month), justified by convenience and safety profile, though payers may scrutinize its cost-effectiveness.

3. What are the major hurdles for KORLYM’s market expansion?

Key obstacles include entrenched competitor therapies, reimbursement and pricing pressures, long-term safety data requirements, and regulatory approval timelines for new indications.

4. Which regions are most promising for KORLYM’s global expansion?

North America and Europe represent initial key markets, with high reimbursement potential. Emerging markets in Asia-Pacific and Latin America hold substantial growth prospects due to increasing healthcare access and aging populations.

5. What future indications could significantly enhance KORLYM’s revenue?

Potential applications in breast cancer, endometriosis, and male hormone therapy may unlock additional revenue streams if clinical trials prove efficacy and safety.

---

References

[1] Food and Drug Administration (FDA). KORLYM (relugolix) approval letter. 2020.
[2] European Medicines Agency (EMA). Summary of Positive Opinion for Relugolix. 2021.
[3] MarketWatch. Global hormonal therapy market forecasts. 2022-2030.
[4] Company press releases and annual reports. 2022-2023.
[5] FDA. Drug Development and Approval Process. 2022.

---