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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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty-seven patent family members in forty-six 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^® Generic Entry Outlook for Erleada

Erleada was eligible for patent challenges on February 14, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2033. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ERLEADA

International Patents:	287
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	22
Patent Applications:	579
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERLEADA

Constraining patent/regulatory exclusivity:

9,481,663

NDA:

210951

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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	60 mg	210951	5	2022-02-14

US Patents and Regulatory Information for ERLEADA

ERLEADA is protected by fifteen US patents.

This potential generic entry date is based on patent 9,481,663.

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

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	9,388,159		Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	10,052,314				Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	11,963,952
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018		RX	Yes	No	9,481,663		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/004452 Erleada 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

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

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
Colombia	7240407	Formas cristalinas de un modulador del receptor androgénico
Eurasian Patent Organization	202090960
South Korea	20200070334
Hong Kong	1252867	用於治療非轉移性去勢抵抗性前列腺癌的抗雄激素 (ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER)

Supplementary Protection Certificates for ERLEADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2368550	CR 2019 00029	Denmark		PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
2368550	C20190027 00294	Estonia		PRODUCT NAME: APALUTAMIID;REG NO/DATE: EU/1/18/1342 16.01.2019
3533792	CA 2021 00041	Denmark		PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2368550	2019/032	Ireland		PRODUCT NAME: APALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/18/1342 20190114

ERLEADA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ERLEADA

Introduction to ERLEADA

ERLEADA, also known as apalutamide, is an androgen receptor inhibitor developed by Johnson & Johnson (J&J) for the treatment of prostate cancer. It has been approved for patients with non-metastatic castration-resistant prostate cancer and is also being evaluated for other indications within the prostate cancer treatment spectrum[4].

Approval and Regulatory Milestones

ERLEADA received its initial approval from Health Canada in July 2018 for the treatment of patients with non-metastatic castration-resistant prostate cancer. This approval was based on the SPARTAN Phase III clinical trial, which demonstrated a significant reduction in the risk of distant metastases or death compared to placebo plus androgen deprivation therapy (ADT)[4].

Clinical Efficacy and Safety

The SPARTAN trial showed that ERLEADA plus ADT decreased the risk of distant metastases or death by 70% compared to placebo plus ADT. The median metastasis-free survival was 2 years longer in patients treated with ERLEADA. The safety profile of ERLEADA has been consistent with previous reports, with treatment-emergent adverse events reported by 99.1% of patients, although most were not severe[4].

Market Position and Competition

ERLEADA enters a market dominated by other prostate cancer therapies, notably J&J's own Zytiga (abiraterone acetate) and Astellas and Pfizer's Xtandi (enzalutamide). Zytiga, once a significant revenue generator for J&J, has faced generic competition since the fourth quarter of 2018, leading to a decline in its market share and sales. For instance, Zytiga's share of total U.S. prescriptions dropped from 56% to 31% between October and January 2019 due to generic competition[1].

Competitive Landscape: Xtandi

Xtandi, approved for both metastatic and non-metastatic prostate cancer, poses a significant competitive challenge to ERLEADA. Xtandi received a label expansion in 2018, making it the only oral medication available for both metastatic and non-metastatic prostate cancer. Pfizer reported $699 million in revenue from Xtandi in 2018, up from $590 million in 2017. Xtandi's market share in the non-metastatic, castrate-resistant setting was quadruple that of ERLEADA's six months after its approval[1].

Financial Performance and Projections

Despite the competitive landscape, ERLEADA is expected to be a key growth driver for J&J. Although its sales have not been astronomical since its launch, supportive data from studies like the TITAN trial, which showed significant benefits in patients with metastatic, castration-sensitive prostate cancer, are expected to expand its label and boost sales. J&J's CFO, Joseph Wolk, emphasized the company's strategies to adapt payer contracts and outcomes-based pilots to highlight the benefits of ERLEADA[1].

Revenue Impact and Market Share

In the context of J&J's overall financial performance, ERLEADA's growth is crucial as the company navigates the decline of Zytiga's sales. J&J reported a 4% year-over-year growth in Zytiga sales in 2018, which was significantly lower than the previous year's growth due to generic competition. ERLEADA's potential to capture a larger market share, especially with its expanding indications, is seen as a way to mitigate these losses[1].

Payer Strategies and Outcomes-Based Models

J&J is focusing on evolving its payer strategies to better communicate the value of ERLEADA. This includes implementing outcomes-based contracts, which could provide a long-term solution by tying payments to the actual outcomes of the treatment. This approach is part of J&J's broader strategy to adapt to changing market dynamics and ensure the sustainability of its products[1].

Recent Clinical Data and Future Prospects

Recent Phase 2 data for ERLEADA plus ADT following radical prostatectomy showed promising results, with no confirmed biochemical recurrence after additional follow-up and a significant rate of serum testosterone recovery. These findings support the potential for ERLEADA in broader treatment settings, further solidifying its position in the prostate cancer market[3].

Financial Trajectory for J&J

In the fourth quarter and full-year 2023, J&J reported overall sales growth, with operational sales increasing by 7.2% and adjusted operational sales by 5.7%. While the company's financial performance is diversified across various therapeutic areas, the success of ERLEADA will be a critical component of its oncology portfolio's growth[5].

Key Takeaways

• Regulatory Approval: ERLEADA has been approved for non-metastatic castration-resistant prostate cancer and is under evaluation for other indications.
• Clinical Efficacy: ERLEADA has shown significant benefits in reducing the risk of distant metastases or death in clinical trials.
• Market Competition: ERLEADA faces competition from Zytiga and Xtandi, but its expanding label and supportive data position it for growth.
• Financial Impact: ERLEADA is expected to mitigate the decline in Zytiga sales and contribute to J&J's overall revenue growth.
• Payer Strategies: J&J is adapting its payer strategies, including outcomes-based models, to enhance ERLEADA's market position.

FAQs

Q: What is ERLEADA used for?

ERLEADA (apalutamide) is used for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Q: How does ERLEADA compare to other prostate cancer treatments?

ERLEADA competes with other treatments like Zytiga (abiraterone acetate) and Xtandi (enzalutamide), but its expanding label and clinical data support its growth potential.

Q: What are the key findings from the TITAN trial?

The TITAN trial showed that patients taking ERLEADA plus ADT had significantly longer survival without cancer progression and death compared to those receiving ADT plus placebo.

Q: How is J&J addressing the decline in Zytiga sales?

J&J is focusing on ERLEADA as a key growth driver and adapting its payer strategies to highlight the benefits of its products.

Q: What are the future prospects for ERLEADA?

ERLEADA's future prospects include potential label expansions and increased market share, driven by supportive clinical data and evolving payer strategies.

Cited Sources

1. Biopharma Dive: "J&J's Erleada has big shoes to fill, and a tough competitor to boot" - January 31, 2019.
2. Royalty Pharma: "Royalty Pharma Reports Second Quarter 2023 Results" - August 8, 2023.
3. Janssen: "Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy" - May 3, 2024.
4. Health Canada: "Summary Basis of Decision for Erleada" - August 27, 2018.
5. Johnson & Johnson: "Johnson & Johnson Reports Q4 and Full-Year 2023 Results" - January 23, 2024.