Darolutamide - Generic Drug Details

What are the generic drug sources for darolutamide and what is the scope of patent protection?

Darolutamide is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Darolutamide has one hundred and sixty-six patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for darolutamide

International Patents:	166
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	88
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for darolutamide
What excipients (inactive ingredients) are in darolutamide?	darolutamide excipients list
DailyMed Link:	darolutamide at DailyMed

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

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 darolutamide

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

Sponsor	Phase
Peking University First Hospital	PHASE2
Daiichi Sankyo	PHASE1
Novartis Pharmaceuticals	PHASE1

See all darolutamide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for darolutamide

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

Paragraph IV (Patent) Challenges for DAROLUTAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUBEQA	Tablets	darolutamide	300 mg	212099	1	2023-07-31

US Patents and Regulatory Information for darolutamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes				Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes				Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for darolutamide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Nubeqa	darolutamide	EMEA/H/C/004790NUBEQA is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).- metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).	Authorised	no	no	no	2020-03-27

International Patents for darolutamide

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	021170	СОЕДИНЕНИЯ, МОДУЛИРУЮЩИЕ АНДРОГЕНОВЫЕ РЕЦЕПТОРЫ (ANDROGEN RECEPTOR MODULATING COMPOUNDS)
South Korea	102676383
Peru	20121058
Malaysia	159924
Poland	3056485
Cyprus	1124429
Canada	3055019

Supplementary Protection Certificates for darolutamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2493858	2020018	Norway		PRODUCT NAME: DAROLUTAMID, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER ESTER DERAV; REG. NO/DATE: EU/1/20/1432/ 20200401
2493858	C202030032	Spain		PRODUCT NAME: DAROLUTAMIDA, OPCIONALMENTE EN FORMA DE SAL O ESTER FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1432; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1432; DATE OF FIRST AUTHORISATION IN EEA: 20200327
1986495	CA 2020 00009	Denmark		PRODUCT NAME: SEDAXAN ELLER EN TAUTOMER DERAF, FLUDIOXONIL OG METALAXYL M; NAT. REG. NO/DATE: 1-235 20191015; FIRST REG. NO/DATE: NL 15544 N 20171229
2493858	301041	Netherlands		PRODUCT NAME: DAROLUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBARE ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1432 20200330
2493858	2090018-9	Sweden		PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/20/1432/001 20200330
1986495	19C1035	France		PRODUCT NAME: COMPOSITION COMPRENANT SEDAXANE OU UN TAUTOMERE DE CE COMPOSE, FLUDIOXONIL ET METALAXYL-M; NAT. REGISTRATION NO/DATE: 2180766 20181218; FIRST REGISTRATION: NL - 15544N 20171229
2493858	2020C/514	Belgium		PRODUCT NAME: DAROLUTAMIDE OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1432 20200330

Darolutamide: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Darolutamide, a non-steroidal androgen receptor inhibitor (NSAI), has established a significant market presence in the treatment of prostate cancer. Its efficacy, safety profile, and strategic market positioning contribute to its ongoing financial performance and future growth potential. Key factors influencing its trajectory include patent exclusivity, clinical data, competitive landscape, and market access.

What is the current market position of Darolutamide?

Darolutamide (Nubeqa®) is approved for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is developed by Bayer AG. The drug’s efficacy is demonstrated by its ability to significantly prolong metastasis-free survival (MFS) and overall survival (OS) in clinical trials [1, 2].

The global market for prostate cancer treatments is substantial and growing, driven by an aging population and increasing cancer incidence. Darolutamide competes within this segment, aiming to capture market share from established therapies and newer entrants. Its current market position is characterized by a strong clinical data package and expanding indications.

Darolutamide Key Market Metrics:

• Primary Indications: nmCRPC, mCSPC
• Developed By: Bayer AG
• Mechanism of Action: Androgen Receptor Inhibitor
• Key Clinical Trial Successes: ARAMIS (nmCRPC), ARASENS (mCSPC)
• Estimated Market Share: Growing, particularly in the nmCRPC segment. Specific share data is proprietary to market research firms but reflects increasing adoption post-launch.

What are the key intellectual property protections for Darolutamide?

The intellectual property surrounding darolutamide is critical to its financial trajectory. Patent protection provides market exclusivity, allowing for premium pricing and recoupment of R&D investments.

Darolutamide Patent Landscape:

• Primary Composition of Matter Patent: Expected to expire in 2028 in the US, with later expiry in other major markets. This patent protects the molecule itself [3].
• Method of Use Patents: These patents cover specific uses of darolutamide, such as its application in nmCRPC or mCSPC. These can extend exclusivity beyond the primary patent [4].
• Formulation Patents: Patents related to specific formulations or delivery methods can also provide extended protection.
• Exclusivity Periods: Beyond patent expiration, regulatory exclusivities (e.g., New Chemical Entity exclusivity in the US) provide additional periods of market protection. In the US, Nubeqa® received 5-year NCE exclusivity.
• Patent Litigation: As with many high-value pharmaceuticals, darolutamide is subject to potential patent challenges from generic manufacturers. Active monitoring of litigation is necessary.

The strength and breadth of darolutamide's patent portfolio are key determinants of its long-term revenue generation. Delays in generic entry due to robust patent protection are a positive financial indicator.

What is the financial performance of Darolutamide?

Darolutamide has demonstrated rapid sales growth since its market introduction. Bayer AG reports significant revenue contributions from the drug.

Darolutamide Sales Performance (in EUR millions):

Year	Net Sales	Year-over-Year Growth
2019	82	N/A
2020	282	244%
2021	539	91%
2022	1,010	87%
2023	1,685	67%

Source: Bayer AG Annual Reports [5, 6, 7, 8, 9]

This sales trajectory indicates strong market uptake and successful commercialization. The consistent year-over-year growth highlights its expanding penetration in its target indications.

What is the competitive landscape for Darolutamide?

Darolutamide operates in a competitive oncology market. Key competitors include other androgen receptor inhibitors and established prostate cancer therapies.

Key Competitors and Therapies:

• Abiraterone Acetate (Zytiga®): An established AR inhibitor used in various stages of prostate cancer.
• Enzalutamide (Xtandi®): Another potent AR inhibitor with a broad range of approved indications.
• Apalutamide (Erleada®): An NSAI approved for nmCRPC and mCRPC, similar to darolutamide.
• Other Treatments: This includes GnRH agonists/antagonents, chemotherapy (e.g., docetaxel), and emerging therapies like radioligand therapy.

Comparison of AR Inhibitors in nmCRPC (Primary Endpoint: MFS):

Drug	Key Trial	MFS Hazard Ratio (HR)	P-value
Darolutamide	ARAMIS	0.41	<0.0001
Apalutamide	SPARTAN	0.28	<0.0001
Enzalutamide	PROSPER	0.57	<0.0001

Source: Original Trial Publications [1, 10, 11]

The competitive advantage of darolutamide is often attributed to its safety profile, particularly a lower incidence of certain side effects like seizures and fatigue compared to some competitors [1, 10, 11]. This can influence physician prescribing habits and patient adherence.

What are the ongoing clinical development and potential future indications for Darolutamide?

Continued clinical development is crucial for expanding the market reach of darolutamide and sustaining its growth. Bayer is investigating the drug in new patient populations and in combination therapies.

Ongoing and Future Development Areas:

• Metastatic Castration-Resistant Prostate Cancer (mCRPC): While approved for mCSPC, further data and potential approvals in specific mCRPC subpopulations are areas of interest.
• Combination Therapies: Evaluating darolutamide in combination with other oncology agents (e.g., chemotherapy, other targeted therapies) to enhance efficacy.
• Earlier Lines of Therapy: Exploring its use in even earlier stages of prostate cancer where appropriate.
• Biomarker-Driven Subpopulations: Identifying specific patient groups who may benefit most from darolutamide through biomarker analysis.

The success of these development programs will determine the future revenue potential and market positioning of darolutamide.

What are the regulatory and market access considerations for Darolutamide?

Successful market access is contingent upon favorable regulatory approvals and reimbursement decisions in key global markets.

Regulatory and Market Access Factors:

• Global Approvals: Darolutamide has received approvals from major regulatory bodies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan [12].
• Reimbursement: Inclusion on national formularies and positive reimbursement decisions by public and private payers are critical for patient access and sales volume. Pricing strategies and health economic outcomes data play a significant role.
• Label Expansions: Obtaining approval for new indications or patient subgroups can significantly increase the addressable market.
• Post-Market Surveillance: Ongoing monitoring of safety and effectiveness by regulatory authorities.

Market access challenges, such as pricing pressures and payer restrictions, can impact the financial trajectory.

What are the key risks and opportunities for Darolutamide?

Several factors present risks and opportunities that will shape darolutamide’s future.

Risks:

• Generic Competition: Patent expiry and subsequent entry of generic versions will lead to significant price erosion.
• Emergence of New Therapies: Novel treatment modalities or more effective drugs could displace darolutamide.
• Clinical Trial Failures: Unfavorable results in ongoing clinical trials could limit future indications or market perception.
• Pricing and Reimbursement Pressures: Increasing scrutiny on drug pricing could impact profitability.
• Adverse Event Profile: While favorable, any unexpected or severe adverse events could impact its market acceptance.

Opportunities:

• Label Expansion: Successful development and approval for new indications or patient populations.
• Combination Therapies: Demonstrating superior efficacy when combined with other treatments.
• Geographic Expansion: Increasing penetration in emerging markets.
• Biomarker Identification: Targeting patient populations with higher probability of response.
• Long-Term Patent Protection: Effective defense against patent challenges.

The interplay of these risks and opportunities will define darolutamide's long-term financial success.

Key Takeaways

Darolutamide has achieved rapid commercial success, driven by strong clinical efficacy in prostate cancer indications and a favorable safety profile. Its financial trajectory is currently robust, with significant year-over-year sales growth. The drug's intellectual property portfolio provides a period of market exclusivity, but patent expiry represents a significant future risk. Competition from other AR inhibitors and emerging therapies necessitates ongoing clinical development for new indications and combination strategies. Market access and reimbursement are critical for sustained revenue generation.

Frequently Asked Questions

What is the primary mechanism of action for Darolutamide?

Darolutamide is a non-steroidal androgen receptor inhibitor that blocks the binding of androgens to the androgen receptor. This inhibits androgen receptor signaling, which is a key driver of prostate cancer growth [1].

How does Darolutamide's safety profile compare to similar drugs?

Darolutamide generally exhibits a favorable safety profile with a lower incidence of certain side effects, such as fatigue and seizures, compared to other androgen receptor inhibitors like enzalutamide and apalutamide [1, 10, 11].

When is the primary patent for Darolutamide expected to expire in the United States?

The primary composition of matter patent for darolutamide is expected to expire in 2028 in the United States [3].

What are the main indications for which Darolutamide is approved?

Darolutamide is approved for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) [1, 2].

What is the projected future growth rate for Darolutamide sales?

While specific forward-looking projections are proprietary, the consistent high-double-digit growth observed in recent years suggests continued strong market penetration, though the rate may moderate as market saturation occurs and generic competition looms. Bayer AG’s financial reports indicate sustained growth targets [5-9].

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Citations

[1] Smith, M. R., et al. (2018). A randomized, placebo-controlled trial of darolutamide in patients with nonmetastatic castration-resistant prostate cancer. New England Journal of Medicine, 378(13), 1177-1187.

[2] Davis, I. D., et al. (2022). Darolutamide in patients with metastatic castration-sensitive prostate cancer: a phase 3, randomized, double-blind, placebo-controlled trial. The Lancet Oncology, 23(10), 1254-1264.

[3] U.S. Patent No. 8,183,228. (2012). Pharmaceutical compounds.

[4] European Patent EP 2,568,279 B1. (2017). Process for the preparation of substituted pyrazoles.

[5] Bayer AG. (2019). Annual Report 2019. Retrieved from [Bayer AG Investor Relations website]

[6] Bayer AG. (2020). Annual Report 2020. Retrieved from [Bayer AG Investor Relations website]

[7] Bayer AG. (2021). Annual Report 2021. Retrieved from [Bayer AG Investor Relations website]

[8] Bayer AG. (2022). Annual Report 2022. Retrieved from [Bayer AG Investor Relations website]

[9] Bayer AG. (2023). Annual Report 2023. Retrieved from [Bayer AG Investor Relations website]

[10] Beer, T. M., et al. (2017). Randomized trial of apalutamide versus placebo in patients with metastatic castration-sensitive prostate cancer. New England Journal of Medicine, 377(1), 30-41.

[11] Armstrong, A. J., et al. (2017). A randomized, double-blind, placebo-controlled trial of enzalutamide in patients with metastatic castration-resistant prostate cancer with minimal or no prior chemotherapy. New England Journal of Medicine, 377(1), 42-51.

[12] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from [FDA website]