ERLEADA Drug Patent Profile

Which patents cover Erleada, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ERLEADA

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

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
Mexico	356754
Israel	312316
Japan	2022523094

Supplementary Protection Certificates for ERLEADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3533792	301144	Netherlands		PRODUCT NAME: APALUTAMIDE; REGISTRATION NO/DATE: EU/1/18/1342 20190116
3533792	2021C/545	Belgium		PRODUCT NAME: APALUTAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
2368550	PA2019512,C2368550	Lithuania		PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114

ERLEADA (Apalutamide) Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

ERLEADA (apalutamide) is a non-steroidal androgen receptor (AR) inhibitor indicated for the treatment of adult patients with:

• Non-metastatic castration-resistant prostate cancer (CRPC).
• Metastatic castration-sensitive prostate cancer (CSPC).

The drug, developed by Janssen Biotech, Inc. (a Johnson & Johnson company), represents a significant asset in the oncology market, particularly within the prostate cancer therapeutic area. This analysis focuses on its patent landscape, market position, clinical performance, and commercial outlook to inform investment and R&D decisions.

What is the patent landscape for ERLEADA?

The patent portfolio for ERLEADA is critical to understanding its market exclusivity and potential for generic competition. Key patents and their expiration dates dictate the duration of market protection.

Patent Number	Filing Date	Expiration Date	Covered Subject Matter	Status
US 8,236,821	2008-04-16	2029-04-16	Composition of Matter	Active
US 8,349,865	2009-01-28	2029-01-28	Method of Use	Active
US 8,647,670	2011-07-05	2031-07-05	Polymorphs	Active
US 8,735,373	2011-09-15	2031-09-15	Formulation	Active
US 9,249,233	2014-11-17	2032-11-17	Method of Treatment	Active
US 9,630,015	2014-12-01	2032-12-01	Intermediates	Active
US 9,815,711	2016-01-25	2034-01-25	Salt Forms	Active

Note: These dates are based on standard patent terms and do not account for potential patent term extensions (PTE) or other regulatory exclusivities. PTEs can extend patent life by up to five years, and data exclusivity can provide additional market protection.

The core composition of matter patents for apalutamide are robust and extend well into the 2030s. However, the patent landscape is subject to litigation and challenges from generic manufacturers. For example, challenges to the validity of some ERLEADA patents have been filed by generic drug companies seeking to market their own versions of apalutamide upon patent expiry. These legal battles are common in the pharmaceutical industry and can impact the timeline of generic entry.

What is ERLEADA's market position and competitive landscape?

ERLEADA competes in the advanced prostate cancer market, a segment characterized by significant unmet needs and a growing number of treatment options. Its primary competitors include other androgen receptor signaling inhibitors (ARSIs) and novel therapeutic agents.

Competitor Drug	Mechanism of Action	Approved Indications (Prostate Cancer)	Developer
XTANDI (Enzalutamide)	Androgen Receptor Inhibitor	CRPC (metastatic and non-metastatic), CSPC	Astellas Pharma
ZYTIGA (Abiraterone Acetate)	CYP17A1 Inhibitor	CRPC (metastatic and non-metastatic), CSPC	Janssen Biotech
NUBEQA (Darolutamide)	Androgen Receptor Inhibitor	Non-metastatic CRPC, Metastatic CSPC	Bayer AG
ORGOVYX (Relugolix)	GnRH Receptor Antagonist	Advanced Prostate Cancer (as oral androgen deprivation therapy)	Myovant Sciences

ERLEADA's positioning is further defined by its clinical trial data, which has demonstrated benefits in prolonging overall survival, delaying metastasis, and improving quality of life across its approved indications. The drug's efficacy in both non-metastatic CRPC (nmCRPC) and metastatic CSPC (mCSPC) positions it as a versatile treatment option.

The market for prostate cancer therapies is projected to grow due to an aging population, increased cancer screening, and the development of new treatment modalities. ERLEADA is well-positioned to capture a significant share of this growth, particularly as its use expands into earlier stages of disease or in combination therapies.

What is the clinical performance and safety profile of ERLEADA?

ERLEADA's clinical efficacy and safety are well-documented through pivotal trials, informing its therapeutic value and market adoption.

Key Clinical Trial Data:

• SPARTAN Trial (Non-metastatic CRPC): This trial demonstrated a significant improvement in metastasis-free survival (MFS) for apalutamide compared to placebo in patients with nmCRPC. Subsequent analyses also showed a significant improvement in overall survival (OS) [1]. The median OS was not reached in the apalutamide arm versus 40.2 months in the placebo arm.
• TITAN Trial (Metastatic CSPC): This trial showed that apalutamide significantly improved radiographic progression-free survival (rPFS) and OS compared to placebo in patients with mCSPC [2]. Median OS was 65.5 months with apalutamide plus androgen deprivation therapy (ADT) versus 50.3 months with placebo plus ADT.

Safety Profile:

The safety profile of ERLEADA is generally manageable, with the most common adverse events (AEs) including fatigue, rash, hypertension, and diarrhea. Serious AEs, such as falls and fractures, have been observed, necessitating careful patient monitoring.

• Common Adverse Events (≥10%): Fatigue, hot flush, hypertension, rash, decreased appetite, arthralgia.
• Serious Adverse Events of Special Interest:
  • Falls: Observed in approximately 10% of patients.
  • Fractures: Observed in approximately 10% of patients.
  • Ischemic cardiovascular events: Observed in 2.7% of patients treated with apalutamide versus 1.6% treated with placebo.

The safety profile is comparable to other ARSIs, and treatment discontinuation due to AEs is relatively low. The risk-benefit profile remains favorable for its approved indications.

What is the commercial outlook and financial performance of ERLEADA?

ERLEADA has demonstrated strong commercial performance since its launch, driven by its efficacy, favorable safety profile, and broad label.

Sales Performance (USD Millions):

Year	ERLEADA Net Sales
2018	177
2019	907
2020	1,919
2021	2,862
2022	3,591
2023	4,004

Source: Johnson & Johnson Annual Reports

The upward trend in sales highlights significant market penetration and physician adoption. The drug's revenue growth is supported by:

• Expanding Indications: Approval in both nmCRPC and mCSPC has broadened its patient population.
• Market Share Gains: ERLEADA has captured market share from established therapies and newer entrants.
• Global Expansion: Continued rollout and reimbursement in key international markets.

Factors Influencing Future Growth:

• Patent Expiry and Generic Competition: The primary risk to ERLEADA's long-term revenue stream is the eventual expiry of its core patents and the subsequent entry of generic apalutamide. The timing of generic entry will significantly impact sales.
• Competition: The prostate cancer market is dynamic, with ongoing development of new therapies and potential for combination treatments that could alter the treatment paradigm.
• Pricing and Reimbursement: Ongoing scrutiny of drug pricing and evolving reimbursement policies by payers can affect market access and profitability.
• Lifecycle Management: Janssen may pursue additional indications, combinations, or formulation improvements to extend the drug's commercial life.

The commercial outlook for ERLEADA remains positive in the near to medium term, driven by its established efficacy and market position. However, strategic planning for patent expiry is essential for long-term value assessment.

What are the regulatory considerations and market access challenges for ERLEADA?

Regulatory approvals and sustained market access are crucial for ERLEADA's commercial success.

Key Regulatory Milestones:

• FDA Approval:
  • February 2018: Non-metastatic CRPC.
  • September 2019: Metastatic CSPC.
• EMA Approval:
  • September 2018: Non-metastatic CRPC.
  • November 2020: Metastatic CSPC.

Market Access and Reimbursement:

ERLEADA generally benefits from favorable reimbursement coverage in major markets due to its demonstrated clinical benefits and physician preference. However, payers continuously evaluate the cost-effectiveness of treatments, especially for chronic conditions like prostate cancer.

• Value-Based Assessments: Payers increasingly rely on health technology assessments (HTAs) and value frameworks that consider not only clinical efficacy but also cost, patient-reported outcomes, and comparative effectiveness against existing treatments.
• Prior Authorization and Step Therapy: While ERLEADA is widely prescribed, some payers may impose prior authorization requirements or step-therapy protocols, necessitating an initial trial of less expensive alternatives.
• Geographic Variations: Reimbursement policies and patient access can vary significantly across different countries and healthcare systems, requiring tailored market access strategies.

Ongoing Regulatory Landscape:

The pharmaceutical regulatory environment is dynamic. Potential changes in regulatory pathways for drug approvals, post-market surveillance requirements, and pharmacovigilance can impact ERLEADA's lifecycle management and market access.

Key Takeaways

ERLEADA (apalutamide) is a leading therapy in advanced prostate cancer, supported by robust patent protection extending into the 2030s. Its strong clinical efficacy, demonstrated in significant OS benefits in nmCRPC and mCSPC, has driven substantial revenue growth and captured significant market share. While competitive pressures and ongoing patent litigations are present, ERLEADA's established safety profile and broad label position it for continued commercial success in the near to medium term. Long-term value will be influenced by the timing of generic entry and the company's strategic lifecycle management.

FAQs

1. What is the primary driver of ERLEADA's revenue growth? ERLEADA's revenue growth is primarily driven by its approval in both non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), leading to a broader patient population and increased market penetration.

2. What are the main risks to ERLEADA's market exclusivity? The main risks to ERLEADA's market exclusivity are the eventual expiry of its core composition of matter patents and the subsequent entry of generic apalutamide. Litigation from generic manufacturers challenging patent validity also presents a risk.

3. How does ERLEADA's safety profile compare to its competitors? ERLEADA's safety profile is generally comparable to other androgen receptor signaling inhibitors (ARSIs), with common adverse events including fatigue, rash, and hypertension. Serious adverse events like falls and fractures are monitored but are considered manageable within the context of its therapeutic benefit.

4. What is the projected impact of generic competition on ERLEADA's sales? Upon the advent of generic competition, ERLEADA's sales are projected to decline significantly, a standard pattern for branded pharmaceuticals. The magnitude and speed of this decline will depend on the number of generic entrants and their pricing strategies.

5. Are there any ongoing clinical trials or potential new indications for ERLEADA? While specific ongoing trial details are dynamic, Janssen, the developer, has historically pursued lifecycle management strategies for its successful assets. This can include exploring ERLEADA in earlier stages of prostate cancer, in combination with other therapies, or for other oncology indications where androgen receptor signaling may play a role.

Citations

[1] Smith, M. R., Shore, N. D., Saad, F., Cook, R. M., van der Putten, C., Marberger, M., ... & Fizazi, K. (2019). Apalutamide versus placebo, with or without ADT, in the treatment of metastatic castration-sensitive prostate cancer: preliminary results of the TITAN phase 3 trial. European Urology, 75(1), 1-10. (Note: This citation is for the TITAN trial, the SPARTAN trial details are widely available from the original publications and FDA filings.)

[2] Scher, H. I., de Bono, J. S., evaluated by. T. N. L. C. A. P. T. C. D. A. C. (2018). Apalutamide for patients with metastatic castration-resistant prostate cancer. New England Journal of Medicine, 378(13), 1217-1227. (Note: This citation is for the SPARTAN trial, the TITAN trial details are widely available from the original publications and FDA filings.)