ERLEADA Drug Patent Profile

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

Erleada is a drug marketed by Janssen Biotech and is included in one NDA. There are twelve patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and fifty patent family members in forty-nine countries.

The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Erleada

A generic version of ERLEADA was approved as apalutamide by ZYDUS on March 17^th, 2025.

Summary for ERLEADA

International Patents:	350
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	22
Patent Applications:	2,269
Drug Prices:	Drug price information for ERLEADA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERLEADA
What excipients (inactive ingredients) are in ERLEADA?	ERLEADA excipients list
DailyMed Link:	ERLEADA at DailyMed

See drug prices for ERLEADA

Recent Clinical Trials for ERLEADA

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

Sponsor	Phase
University of Washington	Phase 2
Jonsson Comprehensive Cancer Center	Phase 2
National Cancer Institute (NCI)	Phase 1

See all ERLEADA clinical trials

Paragraph IV (Patent) Challenges for ERLEADA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ERLEADA	Tablets	apalutamide	240 mg	210951	1	2025-03-20
ERLEADA	Tablets	apalutamide	60 mg	210951	5	2022-02-14

US Patents and Regulatory Information for ERLEADA

ERLEADA is protected by sixteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	12,303,493		Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	9,481,663		Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No	8,802,689
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	9,884,054
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No	8,445,507		Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No	9,481,663		Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	8,445,507		Y	Y

EU/EMA Drug Approvals for ERLEADA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Erleada	apalutamide	EMEA/H/C/004452Erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).	Authorised	no	no	no	2019-01-14

International Patents for ERLEADA

When does loss-of-exclusivity occur for ERLEADA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ERLEADA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2900224	ANTI-ANDROGÈNES POUR LE TRAITEMENT DU CANCER DE LA PROSTATE NON MÉTASTATIQUE, RÉSISTANT À LA CASTRATION (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER)
Denmark	3533792
Canada	3114726	FORMES CRISTALLINES D'UN MODULATEUR DE RECEPTEUR D'ANDROGENE (CRYSTALLINE FORMS OF AN ANDROGEN RECEPTOR MODULATOR)
South Korea	102062024
New Zealand	705815	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer
Mexico	379847	ANTIANDROGENOS PARA EL TRATAMIENTO DEL CANCER DE PROSTATA RESISTENTE A LA CASTRACION NO METASTASICO (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER)
Hungary	E053877

Supplementary Protection Certificates for ERLEADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368550	C20190027 00294	Estonia		PRODUCT NAME: APALUTAMIID;REG NO/DATE: EU/1/18/1342 16.01.2019
2368550	19C1041	France		PRODUCT NAME: APALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/18/1342 20190116; FIRST REGISTRATION: NL - EU/1/18/1342 20190116
3533792	43/2021	Austria		PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
2368550	PA2019512,C2368550	Lithuania		PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550	C 2019 029	Romania		PRODUCT NAME: APALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF NATIONAL AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
2368550	35/2019	Austria		PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: EU/1/18/1342 (MITTEILUNG) 20190116
2368550	300993	Netherlands		PRODUCT NAME: APALUTAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1342 20190116

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ERLEADA

Last updated: September 23, 2025

Introduction

ERLEADA (apalutamide) is an orally administered androgen receptor inhibitor developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. Approved by the U.S. Food and Drug Administration (FDA) in 2018, ERLEADA addresses non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Its market success hinges on competitive advantages, evolving treatment paradigms, regulatory landscape, and broader market forces.

This report explores the current market dynamics and financial trajectory of ERLEADA, providing insights crucial for investors, healthcare strategists, and industry analysts.

---

Market Landscape and Therapeutic Positioning

Prostate Cancer Therapeutics Landscape

Prostate cancer remains the second-most common cancer worldwide, with approximately 1.4 million new cases annually [1]. As therapeutic options expand, agents like ERLEADA compete in a crowded landscape dominated by androgen receptor pathway inhibitors (ARIs) such as enzalutamide, apalutamide, darolutamide, and abiraterone.

ERLEADA's Indications and Competitive Edge

Initially approved for nmCRPC, ERLEADA's pivotal SPARTAN trial demonstrated a 72% reduction in metastasis risk (hazard ratio of 0.28, p<0.0001) [2]. Subsequently, the TITAN trial expanded its label to include mCSPC, showing significant improvements in radiographic progression-free survival and overall survival.

ERLEADA benefits from oral administration, favorable side-effect profile, and strong clinical efficacy, positioning it competitively against enzalutamide and darolutamide. Notably, its integration into standard treatment algorithms as a first-line option enhances its market potential.

---

Market Drivers

Growing Incidence and Early Diagnosis

Advances in screening have increased early detection, expanding the eligible patient pool for ERLEADA. The aging population further amplifies demand, with prostate cancer incidence rising correspondingly [3].

Shifting Treatment Paradigms

The paradigm shift toward earlier use of potent ARIs and combination therapies increases ERLEADA’s utilization. The trend favors aggressive management in high-risk non-metastatic states, aligning with its approved indications.

Regulatory Approvals and Label Expansions

In December 2020, the FDA approved ERLEADA for mCSPC, broadening its market scope. Regulatory agencies in Europe, Japan, and other jurisdictions have issued similar approvals, fostering international growth.

Key Opinion Leader (KOL) Endorsements

Endorsement by oncology KOLs, adherence to evolving guidelines (e.g., NCCN), and inclusion in clinical pathways amplify ERLEADA's market presence.

---

Market Challenges and Barriers

Intense Competition

ERLEADA faces stiff competition from enzalutamide and darolutamide, both with comparable efficacy profiles. Price competition and formulary negotiations influence market share distribution.

Pricing and Reimbursement

High drug costs implicate payer negotiations and reimbursement hurdles. As healthcare systems emphasize value-based care, demonstrating superior cost-effectiveness becomes imperative.

Pipeline Competition

Emerging therapies, such as novel androgen receptor degraders or combination regimens involving immunotherapy, threaten to challenge ERLEADA’s dominance.

Patient and Physician Preferences

Side-effect profiles, oral versus intravenous formulations, and dosing convenience influence prescribing patterns. ERLEADA’s tolerability advantage must be reinforced through real-world data.

---

Financial Trajectory and Revenue Projections

Historical Revenue Performance

Janssen reports ERLEADA revenues in the hundreds of millions annually, with sales reaching approximately $750 million globally in 2022 [4]. Revenue growth aligns with increasing indications, expanded usage, and geographic penetration.

Forecasted Growth Trends

Analysts project a compound annual growth rate (CAGR) of approximately 15-20% through 2027, driven by:

• Expanded approvals and indications
• Increased adoption in early treatment settings
• Rising prostate cancer incidence, especially in aging demographics

Market Penetration Strategies

Janssen’s strategies include expanding clinical indications, pursuing geographic expansion, and engaging in real-world evidence generation to solidify ERLEADA’s positioning.

Pricing Dynamics

Pricing strategies reflect competitive positioning, with list prices in the U.S. estimated at around $15,000 for a 30-day supply [5]. Payer negotiations and cost-effectiveness analyses will influence net revenues.

Reimbursement Environment

Payers increasingly assess value-based metrics. Demonstrating improved progression-free survival and quality-of-life benefits justifies premium pricing efforts, while payers' adoption of step therapy protocols may affect access.

---

Regulatory and Market Expansion Opportunities

Clinical Trials and Expanding Indications

Active development of ERLEADA in combination regimens and earlier treatment lines offers potential for increased market penetration. Ongoing trials explore its role in metastatic hormone-sensitive prostate cancer (mHSPC) and neoadjuvant settings.

International Market Penetration

Regulatory approvals outside North America and Europe remain a priority. Markets like Asia-Pacific and Latin America present significant growth opportunities due to increasing healthcare infrastructure and prostate cancer prevalence.

Potential for Biosimilars and Generics

While ERLEADA's formulation minimizes biosimilar competition, patent protections prolong exclusivity until at least 2030 [6].

---

Market Risks and Future Outlook

Patent Expiration and Generic Competition

Intellectual property lifespan and potential patent challenges will shape long-term revenue prospects. Patent extensions and formulation patents are central strategies for Janssen.

Emerging Therapies and Treatment Shifts

Innovations such as PARP inhibitors and immune checkpoint inhibitors may alter treatment algorithms, potentially impacting ARI market share.

Pricing Pressure and Healthcare Policies

Price controls, value-based pricing models, and increased transparency could constrain revenues. Continued evidence generation emphasizing ERLEADA’s value may mitigate these effects.

COVID-19 Pandemic Impact

Pandemic-related disruptions affect diagnosis rates, clinical trial conduct, and drug dispensation, but long-term impacts are mitigated by ongoing clinical development and market adaptation.

---

Conclusion

ERLEADA's market dynamics are characterized by rapid adoption driven by clinical efficacy, expanding indications, and evolving treatment standards. Financially, Janssen anticipates steady growth, contingent on successful geographic expansion, competitive positioning, and sustained reimbursement support. In a competitive landscape marked by innovation and pricing pressures, strategic positioning and continuous evidence generation remain vital to harnessing ERLEADA's full market potential.

---

Key Takeaways

• ERLEADA holds a leading position in non-metastatic and metastatic prostate cancer therapy due to strong clinical data and expanding indications.
• Market growth is driven by increasing prostate cancer incidence, early diagnosis, and evolving treatment paradigms favoring ARIs.
• Competition from enzalutamide and darolutamide requires ongoing differentiation through clinical outcomes, tolerability, and cost-effectiveness.
• Revenue projections indicate robust growth potential but will depend on regulatory success, international expansion, and market access strategies.
• Long-term success hinges on navigating patent exclusivities, pipeline innovation, and healthcare policy influences.

---

FAQs

1. What distinguishes ERLEADA from other androgen receptor inhibitors?
ERLEADA offers comparable efficacy with a favorable side effect profile, oral administration convenience, and demonstrated benefits in preventing metastasis and delaying disease progression, positioning it effectively within treatment algorithms.

2. How has the FDA approval expansion impacted ERLEADA's market potential?
The FDA's approval for mCSPC has expanded ERLEADA’s usage from non-metastatic to metastatic settings, significantly enlarging the target patient pool and driving revenue growth.

3. What are the primary barriers to ERLEADA's market growth?
Intense competition, pricing pressures, payer reimbursement hurdles, and emerging therapies present ongoing challenges to maximizing market share.

4. What are the prospects for ERLEADA in international markets?
International expansion, particularly in Asia-Pacific, Latin America, and emerging European markets, offers substantial growth opportunities, contingent upon regulatory approval and market access strategies.

5. How might upcoming clinical developments influence ERLEADA’s financial trajectory?
Future trials exploring new combinations and earlier intervention stages could broaden its indications, potentially elevating sales and solidifying its market position.

---

References

[1] International Agency for Research on Cancer (IARC). Globocan 2020 data.
[2] Smith MR, et al. "apalutamide for non-metastatic castration-resistant prostate cancer (SPARTAN): final analysis." Lancet Oncology, 2018.
[3] Siegel RL, et al. "Cancer Statistics, 2022." CA: A Cancer Journal for Clinicians.
[4] Johnson & Johnson Annual Reports, 2022.
[5] GoodRx. ERLEADA pricing data, 2023.
[6] US Patent and Trademark Office. Patent lifecycle for ERLEADA.