XTANDI Drug Patent Profile

Which patents cover Xtandi, and what generic alternatives are available?

Xtandi is a drug marketed by Astellas and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xtandi

A generic version of XTANDI was approved as enzalutamide by ZYDUS PHARMS on September 26^th, 2024.

Summary for XTANDI

International Patents:	184
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	155
Patent Applications:	1,771
Drug Prices:	Drug price information for XTANDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTANDI
What excipients (inactive ingredients) are in XTANDI?	XTANDI excipients list
DailyMed Link:	XTANDI at DailyMed

See drug prices for XTANDI

Recent Clinical Trials for XTANDI

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3
Prostate Cancer Foundation	Phase 1/Phase 2

See all XTANDI clinical trials

Pharmacology for XTANDI

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

Paragraph IV (Patent) Challenges for XTANDI

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 XTANDI

XTANDI is protected by eleven US patents and one FDA Regulatory Exclusivity.

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	213674-002	Aug 4, 2020		RX	Yes	Yes			Y	Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No			Y	Y
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No

EU/EMA Drug Approvals for XTANDI

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 XTANDI

When does loss-of-exclusivity occur for XTANDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Luxembourg

Mexico

Montenegro

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

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 XTANDI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101431407
Russian Federation	2638833	ДИАРИЛГИДАНТОИНЫ (DIARYL HYDANTOINS)
Norway	2017019
Cyprus	1124729
Hong Kong	1217103	二芳基乙內酰脲化合物 (DIARYLHYDANTOIN COMPOUNDS)

Supplementary Protection Certificates for XTANDI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	2013/061	Ireland		PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	SPC/GB13/079	United Kingdom		PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1893196	1390060-0	Sweden		PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
1893196	13C0071	France		PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	CR 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625

XTANDI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XTANDI

Introduction

XTANDI, developed by Astellas and Pfizer, is a pivotal drug in the treatment of prostate cancer, particularly in various stages of the disease. Here, we will delve into the market dynamics and financial trajectory of XTANDI, highlighting its performance, market expansion, and future outlook.

Market Position and Approval History

XTANDI (enzalutamide) has established itself as a leading treatment for prostate cancer, with approvals for multiple indications. It is the sole androgen receptor inhibitor sanctioned by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) experiencing biochemical recurrence at high risk for metastasis[4].

Sales Performance

Global Sales Growth

In FY2023, XTANDI achieved significant global sales growth, reaching JPY 750.5 billion, an increase of about JPY 90 billion or 14% year-over-year (YoY). Excluding the impact of foreign exchange, XTANDI still achieved about 6% growth YoY[1].

Regional Performance

• United States: Despite being on the market for over a decade, XTANDI continued to show strong performance in the US. The approval of the additional indication for M0 CSPC (metastatic castration-sensitive prostate cancer) in November 2022 contributed to this growth. Volume, excluding patient assistance programs, grew steadily by 4% YoY[1].
• International Markets: XTANDI's sales in regions outside the US also saw substantial growth, offsetting some of the challenges faced in the US market. Strong performance in Europe and Japan was particularly noteworthy[3].

Clinical and Regulatory Milestones

Expanded Indications

The FDA approval for XTANDI's use in nonmetastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence marked a significant milestone. This expansion broadens its comprehensive portfolio in prostate cancer treatment, making it available to a broader group of patients[4].

International Regulatory Approvals

XTANDI is currently under review with international regulatory authorities, such as the European Medicines Agency, for an expanded indication for nmHSPC (or nmCSPC) with high-risk BCR, supported by the robust results from the EMBARK study[4].

Financial Outlook for FY2024

Sales Projections

For FY2024, Astellas expects XTANDI sales to reach JPY 757 billion, an increase of JPY 6.6 billion YoY. While global sales are expected to remain at the same level as FY2023, the US market is anticipated to face a decline due to the impact of the US IRA Medicare Part D redesign, estimated to be around USD 50 million to USD 70 million. However, sales outside the US are expected to continue growing, mainly driven by the growth of M1 CSPC (metastatic castration-sensitive prostate cancer)[1].

Cost and Expense Considerations

• Selling, General, and Administrative Expenses: These expenses have increased due to various factors, including foreign exchange rate impacts and increased investments in other products like VEOZAH. However, the reduction of mature products-related costs has partially offset these increases[2].
• Research and Development Expenses: R&D expenses have seen a moderate increase, reflecting ongoing efforts to advance XTANDI and other products in the pipeline[2].

Market Dynamics and Competitive Landscape

Competitive Advantage

XTANDI's robust clinical profile and its exclusive approval for treating three distinct types of prostate cancer give it a significant competitive edge. The drug has demonstrated overall survival benefits for patients with metastatic castration-resistant prostate cancer, nonmetastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer[4].

Market Penetration

The drug's market penetration has been enhanced by updates in clinical guidelines, such as the NCCN Guidelines, which upgraded the level of recommendation for XTANDI in certain indications. This has influenced physician prescribing decisions positively[1].

Impact of Regulatory Changes

US IRA Medicare Part D Redesign

The upcoming changes in the US IRA Medicare Part D redesign, effective in January 2025, are expected to have a negative impact on XTANDI sales in the US. However, this impact is anticipated to be offset by growth in other regions[1].

Future Outlook

Continued Growth

Despite the challenges posed by regulatory changes, XTANDI is expected to continue its growth trajectory, driven by its expanded indications and strong performance in international markets. The ongoing reviews with international regulatory authorities further support its potential for broader market penetration[1][4].

Clinical Development

Astellas remains committed to advancing XTANDI through its clinical development program, aiming to benefit as many prostate cancer patients as possible. This commitment is likely to result in further approvals and expansions, solidifying XTANDI's position in the market[4].

Key Statistics

• FY2023 Sales: JPY 750.5 billion, up by about JPY 90 billion or 14% YoY[1].
• 2022 Sales: $5.9 billion, a 27% surge compared to the previous year[4].
• Patient Impact: 20% to 40% of men who undergo prostate cancer treatment will encounter biochemical recurrence within a decade, with 90% of those with high-risk BCR expected to progress to metastatic disease[4].

Conclusion

XTANDI has established a strong market presence and continues to grow despite market challenges. Its expanded indications, robust clinical profile, and ongoing regulatory approvals position it for continued success in the prostate cancer treatment market.

Key Takeaways

• Strong Sales Growth: XTANDI achieved significant global sales growth in FY2023.
• Expanded Indications: FDA approval for nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.
• International Market Growth: Strong performance in regions outside the US.
• Regulatory Impact: Anticipated decline in US sales due to IRA Medicare Part D redesign, but offset by international growth.
• Clinical Development: Ongoing commitment to advancing XTANDI through clinical development.

FAQs

What are the current indications for XTANDI?

XTANDI is approved for treating metastatic castration-resistant prostate cancer, nonmetastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer, as well as nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence[4].

How has XTANDI's sales performance been in recent years?

In FY2023, XTANDI's global sales reached JPY 750.5 billion, a 14% increase YoY. In 2022, sales surged by 27% to $5.9 billion[1][4].

What is the impact of the US IRA Medicare Part D redesign on XTANDI sales?

The redesign is expected to have a negative impact of around USD 50 million to USD 70 million on XTANDI sales in the US starting in January 2025[1].

How does XTANDI's market position compare to other prostate cancer treatments?

XTANDI holds a unique position as the sole androgen receptor inhibitor approved for treating three distinct types of prostate cancer, giving it a significant competitive edge[4].

What are the future outlook and growth prospects for XTANDI?

Despite regulatory challenges, XTANDI is expected to continue growing, driven by its expanded indications and strong international market performance. Ongoing clinical development and regulatory reviews support its potential for broader market penetration[1][4].

Sources

1. Astellas Pharma Inc. - Financial Results for FY2023.
2. Astellas Pharma Inc. - Financial Results of Astellas for the First Nine Months of FY2023.
3. Astellas Pharma Inc. - Q2/FY2022 FINANCIAL RESULTS.
4. DelveInsight - FDA Grants More Accolades to Xtandi and Keytruda.