Apalutamide - Generic Drug Details

What are the generic sources for apalutamide and what is the scope of freedom to operate?

Apalutamide is the generic ingredient in two branded drugs marketed by Zydus and Janssen Biotech, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apalutamide has two hundred and ninety-four patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for apalutamide

International Patents:	294
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	111
Patent Applications:	2,814
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for apalutamide
What excipients (inactive ingredients) are in apalutamide?	apalutamide excipients list
DailyMed Link:	apalutamide at DailyMed

Recent Clinical Trials for apalutamide

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

Sponsor	Phase
Prostate Cancer Foundation	Phase 2
Merck Sharp & Dohme LLC	Phase 2
Xian-Janssen Pharmaceutical Ltd.	Phase 2

See all apalutamide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for apalutamide

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for APALUTAMIDE

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 apalutamide

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	210951-001	Feb 14, 2018	AB	RX	Yes	No	9,481,663		Y	Y
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-001	Feb 14, 2018	AB	RX	Yes	No	11,963,952
Janssen Biotech	ERLEADA	apalutamide	TABLET;ORAL	210951-002	Feb 17, 2023		RX	Yes	Yes	9,987,261		Y
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	210951-002	Feb 17, 2023		RX	Yes	Yes	RE49353

EU/EMA Drug Approvals for apalutamide

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 apalutamide

Country	Patent Number	Title	Estimated Expiration
Slovenia	2858985
Poland	2656841
Chile	2015000715	Anti-androgenos para el tratamiento de cáncer prostatico no metastasico y resistente de castracion
Japan	6182209
Philippines	12018502569	ANTI-ANDROGENS FOR THE TREATMENT OF NON-METASTATIC CASTRATE-RESISTANT PROSTATE CANCER

Supplementary Protection Certificates for apalutamide

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	C201930040	Spain		PRODUCT NAME: APALUTAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
2368550	765	Finland
2368550	CR 2019 00029	Denmark		PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
3533792	CA 2021 00041	Denmark		PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116

Market Dynamics and Financial Trajectory for Apalutamide

Introduction to Apalutamide

Apalutamide, marketed under the brand name ERLEADA®, is an androgen receptor inhibitor used in the treatment of prostate cancer. It is indicated for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC)[3][5].

Market Indications and Approval

Apalutamide received FDA approval for nmCRPC in February 2018 and for mCSPC in September 2019. This approval was based on significant clinical trials, including the SPARTAN and TITAN studies, which demonstrated its efficacy in improving metastasis-free survival and overall survival in these patient populations[3][5].

Clinical Efficacy and Impact

The clinical efficacy of apalutamide has been well-documented. In the SPARTAN study, apalutamide significantly improved metastasis-free survival compared to placebo in patients with nmCRPC. The study showed a median metastasis-free survival of 40.5 months for apalutamide versus 16.2 months for placebo[3].

In the context of mCSPC, a real-world head-to-head study comparing apalutamide to enzalutamide found that apalutamide provided a statistically significant overall survival benefit, reducing the risk of death by 23% at 24 months[4].

Market Growth and Projections

The global pharmaceutical grade apalutamide market is expected to see significant growth. The market research report for 2023-2029 indicates a rising demand driven by the increasing incidence of prostate cancer and the efficacy of apalutamide in treating advanced stages of the disease[1].

Patient Population and Market Size

Approximately 300,000 people are diagnosed with prostate cancer each year in the U.S., with a substantial portion being classified as high-risk. Up to 40% of patients with prostate cancer may be categorized as high-risk, and up to 50% of patients experience disease recurrence within ten years of surgery, highlighting the large potential market for apalutamide[2][4].

Financial Performance

Since its approval, apalutamide has been prescribed to over 100,000 patients worldwide. The introduction of a new 240mg tablet strength has provided prescribers with more flexibility, potentially increasing patient adherence and market penetration[5].

Pricing and Accessibility

The pricing of apalutamide is a critical factor in its market dynamics. While the exact pricing can vary, the availability of different tablet strengths (60mg and 240mg) allows for flexibility in prescribing, which can impact the overall cost and accessibility of the treatment for patients[5].

Safety Profile and Adverse Events

The safety profile of apalutamide is generally acceptable, with common adverse events including fatigue, arthralgia, rash, and decreased appetite. Serious adverse events such as falls, fractures, and rare cases of seizure have also been reported. However, these are consistent with the profile of androgen deprivation therapy and do not significantly deter from its market potential[3][5].

Competitive Landscape

Apalutamide operates in a competitive landscape that includes other androgen receptor inhibitors like enzalutamide. However, its unique once-daily, single-tablet formulation and demonstrated clinical benefits make it a preferred option for many prescribers and patients. The real-world study comparing apalutamide to enzalutamide further solidifies its position in the market[4][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of apalutamide. FDA approvals and ongoing clinical trials continue to support its use and expansion into new indications. For instance, the Apa-RP study evaluating apalutamide plus androgen deprivation therapy following radical prostatectomy has shown promising results, which could further broaden its market reach[2].

Future Prospects and Research

Ongoing and future clinical trials, such as the Apa-RP study, are critical in understanding the full potential of apalutamide in earlier stages of prostate cancer. These studies aim to reduce the risk of biochemical recurrence and progression to metastatic disease, which could significantly impact the market trajectory of the drug[2].

Key Takeaways

• Clinical Efficacy: Apalutamide has demonstrated significant clinical benefits in treating nmCRPC and mCSPC.
• Market Growth: The global market for apalutamide is expected to grow driven by increasing prostate cancer incidence and the drug's efficacy.
• Patient Population: A large patient population, including high-risk cases, contributes to the market size.
• Financial Performance: Over 100,000 patients worldwide have been treated with apalutamide, indicating strong market penetration.
• Safety Profile: The safety profile is generally acceptable, with manageable adverse events.
• Competitive Landscape: Apalutamide stands out due to its unique formulation and demonstrated clinical benefits.
• Regulatory Environment: FDA approvals and ongoing trials support its market position.

FAQs

Q1: What is apalutamide used for? Apalutamide is used for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC)[3][5].

Q2: What are the common adverse events associated with apalutamide? Common adverse events include fatigue, arthralgia, rash, and decreased appetite. Serious adverse events such as falls, fractures, and rare cases of seizure have also been reported[3][5].

Q3: How does apalutamide compare to other androgen receptor inhibitors? Apalutamide has demonstrated a statistically significant overall survival benefit compared to enzalutamide in real-world studies, making it a preferred option for many prescribers and patients[4].

Q4: What is the current market size and growth potential for apalutamide? The global market for apalutamide is expected to grow significantly, driven by the increasing incidence of prostate cancer and the drug's efficacy. Over 100,000 patients worldwide have been treated with apalutamide[1][5].

Q5: Are there ongoing clinical trials for new indications of apalutamide? Yes, ongoing clinical trials such as the Apa-RP study are evaluating the use of apalutamide in new indications, including its use following radical prostatectomy to prevent biochemical recurrence[2].

Sources

1. Market Research Reports: Global Pharmaceutical Grade Apalutamide Market Growth 2023-2029.
2. Janssen: Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy.
3. FDA: 210951Orig1s000 - accessdata.fda.gov.
4. PR Newswire: ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer.
5. Janssen: ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor Once-Daily Single Tablet.

Last updated: 2024-12-16