DAROLUTAMIDE - Generic Drug Details

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

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:	86
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

Constraining patent/regulatory exclusivity:

11,168,058

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
Novartis Pharmaceuticals	PHASE1
University of Chicago	PHASE4
Peter MacCallum Cancer Centre, Australia	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	12,329,742		Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	10,711,013		Y	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	9,657,003		Y	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	8,975,254		Y	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	10,010,530			Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	10,383,853			Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	10,835,515		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
Portugal	2493858
Spain	3027971
Denmark	2493858
Eurasian Patent Organization	021170
South Korea	20160105927
Norway	2020018
Cyprus	1124429

Supplementary Protection Certificates for DAROLUTAMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2493858	20C1028	France		PRODUCT NAME: DAROLUTAMIDE Y COMPRIS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET SES ESTERS COUVERTS PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/20/1432/001 20200330
1986495	SPC/GB18/044	United Kingdom		PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND METALAXYL M; REGISTERED: NL NL 15544 N 20171229; UK MAPP NO. 18588 20180619
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	PA2020514,C2493858	Lithuania		PRODUCT NAME: DAROLUTAMIDAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327
2493858	SPC/GB20/022	United Kingdom		PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/20/1432/001(NI) 20200330; UK PLGB 00010/0677 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	122020000030	Germany		PRODUCT NAME: DAROLUTAMID; NAT. REGISTRATION NO/DATE: EU/1/20/1432 20200327; FIRST REGISTRATION: EU EU/ 1/2011432 20200327

Market Dynamics and Financial Trajectory for Darolutamide

Last updated: July 28, 2025

Introduction

Darolutamide, marketed as Nubeqa, is an androgen receptor inhibitor developed primarily to treat non-metastatic castration-resistant prostate cancer (nmCRPC). Since its FDA approval in July 2019, the drug has gained traction within the oncology therapeutic space, driven by escalating prostate cancer prevalence, competitive differentiation, and evolving treatment guidelines. This report comprehensively examines the market dynamics and financial trajectory of darolutamide, highlighting factors shaping its growth, competitive landscape, and future revenue potential.

---

Market Overview and Epidemiological Context

Prostate cancer remains the second most common malignancy among men worldwide, with an estimated 1.4 million new cases and over 375,000 deaths globally in 2020 [1]. Non-metastatic castration-resistant prostate cancer, characterized by disease progression despite androgen deprivation therapy (ADT) without distant metastasis, affects roughly 15-20% of advanced prostate cancer patients [2]. The expanding patient pool, coupled with improved diagnostic techniques, positions nmCRPC as a significant market segment for emerging therapies.

---

Key Drivers Influencing Market Dynamics

1. Clinical Efficacy and Regulatory Approval

Darolutamide’s approval was grounded in the ARAMIS trial, which demonstrated significant metastasis-free survival (MFS) benefits—median MFS of 40.4 months compared to 18.4 months with placebo [3]. Its favorable safety profile, distinguished by lower central nervous system side effects due to limited blood-brain barrier penetration, further bolsters its clinical appeal. Regulatory endorsements from the FDA and EMA have cemented darolutamide’s role, encouraging adoption among urologists and oncologists.

2. Competitive Landscape and Differentiation

Darolutamide faces competition primarily from apalutamide (Erleada) and enzalutamide (Xtandi), both indicating robust market shares in nmCRPC and metastatic castration-resistant prostate cancer (mCRPC) indications. Key differentiators for darolutamide include its tolerability profile and reduced risk of adverse CNS events, which appeal to patients with comorbidities or sensitivities.

The insurmountable efficacy differences are minimal; hence, market share shifts depend significantly on safety perceptions, prescriber familiarity, and formulary preferences.

3. Clinical Guidelines and Physician Adoption

Evolving treatment guidelines from NCCN and European associations endorse darolutamide as a preferred option alongside other androgen receptor inhibitors. Early prescriber adoption has been favorable, yet widespread uptake hinges on awareness campaigns and real-world evidence supporting its safety and efficacy outside clinical trials.

4. Pricing Strategies and Reimbursement Access

Since its launch, darolutamide has maintained competitive pricing—approximately $12,000–$13,000 per month—aligned with other advanced prostate cancer therapies. Payer coverage, copay assistance programs, and formulary placements critically influence accessibility and, consequently, sales.

5. Patent Lifespan and Generics Entry

Patent protection for darolutamide is slated to extend to approximately 2034, providing a window of exclusivity for revenue generation. Pending biosimilar or generic manufacturing remains unlikely given current patent protections.

---

Financial Trajectory and Revenue Forecasts

1. Sales Performance and Market Penetration

Since its launch, darolutamide has achieved steady sales growth. The company reports global revenues exceeding $115 million in the first full year post-launch (2020 data), with projections of reaching approximately $250–$300 million by 2023, accounting for increasing adoption and expanded indications [4].

Key markets, including the U.S., European Union, and Japan, are primary revenue sources. The U.S. accounts for a significant share, driven by high prostate cancer prevalence and favorable reimbursement pathways.

2. Expansion Opportunities and Off-label Use

Beyond nmCRPC, darolutamide's potential in metastatic settings and combination therapies is under investigation. Successful clinical trial outcomes could unlock additional revenue streams, extending its market reach.

3. Impact of Market Competition

While darolutamide holds an early-mover advantage, intensified competition from existing and pipeline drugs may temper revenue growth. The launch of next-generation androgen receptor inhibitors with superior efficacy or safety could challenge darolutamide’s market share.

4. Market Penetration Barriers

Physician inertia, patient preferences, and formulary restrictions could delay full market penetration. Ongoing education and presentation of real-world data are necessary to sustain growth momentum.

---

Emerging Trends and Future Outlook

- Biomarker-Guided Therapy and Personalized Medicine

Advances in diagnostic biomarkers may enable tailored therapies, influencing drug selection and market dynamics. Darolutamide's differential safety profile might favor certain patient subgroups, optimizing its utilization.

- Combination Regimens

Clinical trials exploring darolutamide in combination with chemotherapies, immunotherapies, or other targeted agents could redefine treatment protocols, stimulating sales.

- Geographic Expansion

Emerging markets, such as Asia-Pacific and Latin America, present growth opportunities. Regulatory approvals and health infrastructure development are critical for future expansion.

---

Regulatory and Patent Outlook

Continued regulatory support and patent enforcement are crucial for safeguarding market exclusivity. Potential patent litigations or challenges could impact future revenues. The strategic landscape emphasizes safeguarding data exclusivities and exploring new intellectual property avenues.

---

Key Takeaways

• Market Growth Driven by Rising Prostate Cancer Incidence: The expanding patient pool sustains the demand for effective nmCRPC therapies like darolutamide.

• Competitive Differentiation Favors Safety Profile: Darolutamide’s reduced CNS side effects offer a compelling advantage, positively influencing prescriber preference.

• Revenue Trajectory Anchored on Clinical Adoption and Reimbursement: Steady sales growth is expected, contingent upon physician acceptance, formulary integration, and geographical expansion.

• Pipeline and Combination Strategies Expand Market Potential: Ongoing trials and combination therapies may elevate darolutamide’s position, opening new revenue channels.

• Competitive Threats and Patent Management Are Critical: Vigilant monitoring of competitor pipelines and patent protections will determine long-term market share and profitability.

---

FAQs

Q1: What differentiates darolutamide from other androgen receptor inhibitors?
A: Darolutamide exhibits enhanced safety due to limited blood-brain barrier penetration, reducing CNS-related side effects like seizures or cognitive disturbances—a key differentiator from apalutamide and enzalutamide.

Q2: What is the current market size for darolutamide in prostate cancer therapy?
A: The global sales revenue exceeded $115 million in 2020, with projections approaching $300 million by 2023, driven by increasing adoption and expanded indications.

Q3: What are the primary challenges facing darolutamide's market growth?
A: Challenges include intense competition from established drugs, prescriber inertia, formulary access barriers, and potential future patent litigations.

Q4: Are there ongoing clinical trials for darolutamide in other cancer settings?
A: Yes, trials examine its efficacy in metastatic prostate cancer and in combination with other therapies, seeking to broaden its application horizons.

Q5: How might emerging biosimilars or generics impact darolutamide’s revenue?
A: Given current patent protections, biosimilars are unlikely soon. However, patent expiry around 2034 could eventually lead to generic competition, potentially eroding market share.

---

References

[1] International Agency for Research on Cancer. "Global Cancer Statistics 2020."

[2] National Cancer Institute. "Prostate Cancer—Statistics."

[3] Hussain, M. et al. "Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer." The New England Journal of Medicine, 2019.

[4] Company Financial Reports and Market Analysis Data, 2021.