ENZALUTAMIDE - Generic Drug Details

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

Enzalutamide is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, Zydus Pharms, and Astellas, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Enzalutamide has one hundred and eighty-four patent family members in thirty-four countries.

There are nine drug master file entries for enzalutamide. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for ENZALUTAMIDE

International Patents:	184
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	342
Patent Applications:	3,913
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENZALUTAMIDE
What excipients (inactive ingredients) are in ENZALUTAMIDE?	ENZALUTAMIDE excipients list
DailyMed Link:	ENZALUTAMIDE at DailyMed

Recent Clinical Trials for ENZALUTAMIDE

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

Sponsor	Phase
University of Oklahoma	Phase 1
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3

See all ENZALUTAMIDE clinical trials

Generic filers with tentative approvals for ENZALUTAMIDE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL
		80MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ENZALUTAMIDE

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers

Anatomical Therapeutic Chemical (ATC) Classes for ENZALUTAMIDE

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

Paragraph IV (Patent) Challenges for ENZALUTAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTANDI	Tablets	enzalutamide	40 mg and 80 mg	213674	1	2021-03-31
XTANDI	Capsules	enzalutamide	40 mg	203415	3	2016-08-31

US Patents and Regulatory Information for ENZALUTAMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No
Apotex	ENZALUTAMIDE	enzalutamide	CAPSULE;ORAL	209645-001	Apr 22, 2022		DISCN	No	No
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes

EU/EMA Drug Approvals for ENZALUTAMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Xtandi	enzalutamide	EMEA/H/C/002639 Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	Authorised	no	no	no	2013-06-21	2013-04-26

International Patents for ENZALUTAMIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2884795	FORMULATIONS D'ENZALUTAMIDE (FORMULATIONS OF ENZALUTAMIDE)
Spain	2378778
Japan	2021178871	エンザルタミドの製剤 (FORMULATIONS OF ENZALUTAMIDE)

Supplementary Protection Certificates for ENZALUTAMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	169 50005-2013	Slovakia		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	70/2013	Austria		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/836 20130621
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625

ENZALUTAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Enzalutamide (Xtandi)

Introduction

Enzalutamide, marketed under the brand name Xtandi, is a potent drug in the treatment of prostate cancer, particularly for patients with metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). This article delves into the market dynamics and financial trajectory of enzalutamide, highlighting its pricing, market growth, and the challenges it faces.

Mechanism of Action and Clinical Significance

Enzalutamide is a triple-acting androgen receptor antagonist that inhibits the activity of androgen receptors in prostate cancer cells, reducing cell proliferation and serum prostate-specific antigen (PSA) levels. This mechanism makes it a crucial treatment option for prostate cancer patients, especially in cases where hormone resistance is a concern[4].

Market Size and Growth

The global prostate cancer drugs market, which includes enzalutamide, is experiencing robust growth. In 2023, the market was valued at $18.81 billion and is projected to reach $23.50 billion by 2027, with a compound annual growth rate (CAGR) of 5.7%[3].

Regional Market Performance

North America is the largest region in the prostate cancer drugs market, driven by a high prevalence of prostate cancer and advanced healthcare infrastructure. The Middle East is expected to be the fastest-growing region during the forecast period. Enzalutamide's global sales have shown significant growth, particularly in Europe and Japan, where it has achieved strong demand and obtained reimbursement in several countries[3][4].

Pricing and Cost Implications

One of the most contentious issues surrounding enzalutamide is its high pricing. In the United States, the average wholesale price of enzalutamide was $88 per capsule in 2015, resulting in an annual cost of approximately $129,000 per patient. This is more than twice the price in Germany, the next highest country, where a capsule costs around $36.93[1].

Financial Burden on Patients and Healthcare Systems

The high cost of enzalutamide leads to significant financial burdens on patients and healthcare systems. This has resulted in increased pre-authorization requirements and cost-sharing arrangements, which can be financially ruinous for many patients. The inability of the Centers for Medicare & Medicaid Services (CMS) to negotiate drug prices or refuse to purchase drugs due to US policies exacerbates this issue[1].

Revenue and Sales Performance

Enzalutamide has been a lucrative drug for its manufacturers. Total Medicare spending on Xtandi grew from under $35 million in 2012 to nearly $447 million in 2014, with the number of patients increasing from 2,143 to 11,800 during the same period. The US market represented 61% of Xtandi sales in 2015, according to Astellas' annual report[1].

Financial Performance of Astellas

Astellas Pharma Inc., the sub-licensee of enzalutamide, has seen substantial revenue from the drug. In FY2022, global sales of Xtandi continued to grow, although revenue from clinical orders in the US was below expectations due to affordability challenges and generic competitor share. Despite these challenges, Xtandi remains the leading branded novel hormonal therapy (NHT) across all indications[2].

Development and Licensing

The early development of enzalutamide was conducted at the University of California, Los Angeles (UCLA), with significant funding from the National Institutes of Health (NIH) and other federal agencies. UCLA sold its 44% royalty interest in the drug to Royalty Pharma for $520 million plus a potential share of future sales, highlighting the lucrative nature of the drug's development[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of enzalutamide. The FDA has approved enzalutamide for various indications, including non-metastatic castration-resistant prostate cancer. This favorable regulatory environment encourages further investment in the development of prostate cancer drugs[3].

Emerging Trends and Challenges

Combination Therapy

An emerging trend in the treatment of prostate cancer is the use of combination therapy. For instance, the Phase 3 PROSPER trial showed that using Xtandi in combination with androgen deprivation therapy (ADT) significantly reduced the risk of metastases or death by 71% compared to ADT alone. This approach is expected to improve treatment outcomes and drive market growth[3].

Recurrent/Non-Responsive Prostate Cancer

Despite the advancements, recurrent or non-responsive prostate cancer remains a significant challenge. This form of cancer leads to recurrence or spread after initial treatment, affecting a considerable percentage of high-risk prostate cancer patients. Addressing this challenge is crucial for the continued growth of the prostate cancer drugs market[3].

Financial Projections and Future Outlook

Global sales of Xtandi are expected to continue growing, although at a slower rate due to the loss of exclusivity and the emergence of generic competitors. By 2026, the global sales of Xtandi are projected to decline at a certain CAGR, reflecting the impact of these market dynamics[4].

Key Takeaways

• High Pricing and Financial Burden: Enzalutamide's high cost poses significant financial challenges for patients and healthcare systems.
• Market Growth: The global prostate cancer drugs market, including enzalutamide, is expected to grow to $23.50 billion by 2027.
• Regional Performance: North America is the largest market, with the Middle East expected to be the fastest-growing region.
• Regulatory Environment: Favorable FDA approvals and regulatory conditions support market growth.
• Emerging Trends: Combination therapy is becoming increasingly important in treating prostate cancer.
• Challenges: Recurrent/non-responsive prostate cancer and the emergence of generic competitors are key challenges.

FAQs

What is the primary mechanism of action of enzalutamide?

Enzalutamide acts as a triple-acting androgen receptor antagonist, inhibiting the activity of androgen receptors in prostate cancer cells, which reduces cell proliferation and serum PSA levels[4].

How much does enzalutamide cost in the United States?

The average wholesale price of enzalutamide in the United States was $88 per capsule in 2015, resulting in an annual cost of approximately $129,000 per patient[1].

What are the projected global sales of enzalutamide by 2027?

Global sales of Xtandi are expected to continue growing but will eventually decline due to the loss of exclusivity. However, the exact projection by 2027 is not specified in the available data, but the overall prostate cancer drugs market is expected to reach $23.50 billion[3][4].

What are the main regions driving the growth of the prostate cancer drugs market?

North America is the largest region, while the Middle East is expected to be the fastest-growing region during the forecast period[3].

What are the emerging trends in the treatment of prostate cancer using enzalutamide?

The use of combination therapy, such as combining enzalutamide with androgen deprivation therapy (ADT), is an emerging trend that has shown significant improvements in treatment outcomes[3].

Sources

1. OncLive: Enzalutamide Pricing Debate Goes to Washington
2. Astellas Pharma Inc.: FY2022 FINANCIAL RESULTS
3. GlobeNewswire: Global Prostate Cancer Drugs Market Shows Robust Growth
4. GlobalData: The Global Drug sales of Xtandi (2020 - 2026, USD Millions)