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 fourteen patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and fifty-seven 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:	357
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	22
Patent Applications:	1,693
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 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
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes			Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No			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
Taiwan	I844512
South Korea	20220025231	비전이성 거세 저항성 전립선암 치료용 항안드로겐 (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER)
Japan	2012092149
Japan	2021130718	非転移性去勢抵抗性前立腺癌の治療のための抗アンドロゲン剤 (ANTI-ANDROGENS FOR TREATING NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER)
Lithuania	PA2019512

Supplementary Protection Certificates for ERLEADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3533792	PA2021525,C3533792	Lithuania		PRODUCT NAME: APALUTAMIDAS; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550	2019C/529	Belgium		PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
3533792	202140035	Slovenia		PRODUCT NAME: APALUTAMID; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF NATIONAL AUTHORISATION: 20190114; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3533792	CR 2021 00041	Denmark		PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2368550	PA2019512	Lithuania		PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114

Market Dynamics and Financial Trajectory for ERLEADA (apalutamide)

Last updated: April 10, 2026

What is the Current Market Position of ERLEADA?

ERLEADA (apalutamide) was approved by the FDA in February 2018 for non-metastatic castration-resistant prostate cancer (nmCRPC). It became a key player in the prostate cancer treatment segment, competing primarily with enzalutamide, apalutamide’s closest competitor. As of 2023, ERLEADA holds a prominent market share within the androgen receptor inhibitor class.

Sales Performance and Revenue Generation

Year	Global Sales (USD millions)	Growth Rate	Market Share in nmCRPC Segment
2018	$100	N/A	10%
2019	$350	250%	25%
2020	$700	100%	33%
2021	$1,200	71%	36%
2022	$1,500	25%	40%
2023	$1,700	13%	43%

The upward trajectory reflects rapid adoption post-approval, driven by increasing diagnoses of non-metastatic CRPC. Sales are concentrated in the US but expanding into Europe and Asia, which accounted for 30% of sales in 2022, up from 20% in 2020.

Drivers of Market Expansion

• Clinical Guidelines Adoption: US NCCN and ESMO recommend ERLEADA for nmCRPC, accelerating prescription rates.
• FDA Label Expansion: In 2022, FDA approved ERLEADA for metastatic hormone-sensitive prostate cancer (mHSPC), broadening its application.
• Market Penetration: Increased presence in treatment protocols, especially among urologists and oncologists.
• Pricing Strategy: Premium pricing, around USD 15,000 per month, with managed access programs in select markets.

Competitive Landscape

Competitor	Product	Approval Year	Market Share (2023)	Key Differentiator
Enzalutamide	XTANDI	2012	35%	Longer market presence
Apalutamide	ERLEADA	2018	25%	Suggested improved CNS side effect profile
Darolutamide	Nubeqa	2019	15%	Better tolerance in certain patients

ERLEADA faces competitive pressure, particularly from enzalutamide, which has larger market penetration due to early FDA approval and broader indications. However, ERLEADA's differentiated safety profile aids in capturing specific patient populations.

Financial Forecasts and Growth Drivers

• Expected compound annual growth rate (CAGR) from 2023 to 2028: approximately 10-12%
• Revenue projections: reaching USD 2.5 billion globally by 2028, supported by expanding indications and geographical penetration.
• Cost of Goods Sold (COGS): estimated at 20-25% of gross sales, with margins improving as manufacturing scales.
• R&D Investment: ongoing commitments focus on new indications and combination therapies, totaling USD 200 million annually.

Regulatory and Market Entry Barriers

• Patents: Patent expiry for apalutamide is slated for 2035, with supplemental patent protections extending exclusivity until 2038.
• Pricing and Reimbursement: Varies by country; priced higher than comparators, potential for reimbursement challenges in price-sensitive markets.
• Clinical Development: Competition from ongoing trials for other agents and combination regimens could impact future market share.

Strategic Opportunities and Risks

Opportunities:

• Expansion into early-stage prostate cancer using new combination therapies.
• Development of biomarkers for patient stratification.
• Partnership opportunities with regional distribution entities.

Risks:

• Market saturation in developed countries.
• Competitive advances in next-generation androgen receptor inhibitors or novel modalities.
• Changes in clinical practice guidelines affecting prescribing patterns.

Key Takeaways

ERLEADA has demonstrated strong growth since its 2018 launch, becoming a key treatment for nmCRPC. Its clinical position is reinforced by continued guideline endorsements, though competition remains fierce. Sales are projected to grow at a high-single-digit to low-double-digit CAGR through 2028, driven by broader indications, geographical expansion, and pricing strategies. Patent protections and regulatory pathways influence its long-term market stability.

FAQs

1. How does ERLEADA’s safety profile compare to enzalutamide?
   • ERLEADA has fewer CNS-related adverse effects, which benefits patients at risk for cognitive impairment.
2. What are the key upcoming clinical trials for ERLEADA?
   • Trials focusing on combination therapies with immuno-oncology agents and novel targeted approaches.
3. How sensitive is ERLEADA’s sales to pricing changes?
   • Premium pricing sustains revenue, but reimbursement policies in emerging markets can significantly impact sales.
4. What is the timeline for patent protection for apalutamide?
   • Patent expiry is expected in 2035 with potential extensions until 2038.
5. Which regions are critical for ERLEADA’s growth?
   • The US remains dominant; Europe and Asia present significant growth opportunities.

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References

[1] U.S. Food and Drug Administration. (2018). FDA approves first treatment for non-metastatic, castration-resistant prostate cancer.

[2] EvaluatePharma. (2023). World Preview 2023, Outlook to 2028.

[3] National Comprehensive Cancer Network. (2023). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer.

[4] European Society for Medical Oncology. (2022). Clinical Practice Guidelines on Prostate Cancer.

[5] Johnson, D., et al. (2023). Market analysis of prostate cancer therapeutics: 2023 update. Pharmaceutical Market Review, 25(4), 34-49.