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-eight patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for darolutamide

International Patents:	168
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			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	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	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes				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
Serbia	53469
Lithuania	PA2020514
Colombia	6531494
Argentina	078793
Portugal	1986495
Slovenia	2493858
Canada	3145459

Supplementary Protection Certificates for darolutamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2493858	LUC00154	Luxembourg		PRODUCT NAME: DAROLUTAMIDE EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1432/001 20200330
1986495	1890044-9	Sweden		PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND MEALAXYL M; NAT. REG. NO/DATE: 5444 20180608; FIRST REG.: NL 15544 N 20171229
2493858	CA 2020 00020	Denmark		PRODUCT NAME: DAROLUTAMID EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER EN FARMACEUTISK ACCEPTABELT ESTER DERAF; REG. NO/DATE: EU/1/20/1432/001 20200330
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	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	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
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

Darolutamide (Nubeqa): Market Dynamics and Financial Trajectory

Last updated: May 8, 2026

What is the market context for darolutamide?

Darolutamide is an androgen receptor pathway inhibitor (ARPI) used in prostate cancer and commercialized in multiple countries under Nubeqa (Bayer). Its market positioning is shaped by the late-stage shift in metastatic castration-resistant prostate cancer (mCRPC) treatment toward ARPIs and by competitive head-to-head differentiation on survival benefit, tolerability, and dosing logistics.

Core indication footprint

• Non-metastatic castration-resistant prostate cancer (nmCRPC): standard-of-care role strengthened by modern trial design that supported use with androgen deprivation therapy.
• Metastatic castration-resistant prostate cancer (mCRPC): adopted across treatment pathways where ARPIs are preferred before chemotherapy.

(Clinical differentiation is heavily driven by pivotal trial data and label scope. Commercial outcomes largely follow the label boundaries and uptake in physicians’ treatment algorithms.)

Competitive landscape

Darolutamide competes primarily in the ARPI class for both nmCRPC and mCRPC sequencing. Key rivals include:

• Apalutamide (Erleada)
• Enzalutamide (Xtandi)
• Abiraterone (Zytiga) in selected pathways and earlier lines where applicable

Practical commercial impact: ARPI competition is less about efficacy headline numbers and more about:

• Total addressable patient pool covered by label
• Physician switching behavior across lines
• Payer access and step edits
• Net price pressure tied to contracting intensity and formulary placement

How do market dynamics shape uptake and pricing?

Darolutamide’s sales trajectory is a function of payer access, guideline adoption, and sequencing pressure from competing ARPIs.

1) Formulary access and contracting

ARPI class drugs face:

• Highly managed payer formularies (national and regional)
• Patient out-of-pocket cost controls through copay and assistance programs
• Intensifying rebates tied to market share stability

Commercial implication: even when clinical outcomes support use, net revenue is constrained by payer negotiation. This typically pushes sales growth to be driven by volume expansion (more patients treated) rather than pure price expansion.

2) Sequencing and line-of-therapy behavior

Uptake increases when darolutamide is perceived as:

• A “preferred” option in physician choice sets for mCRPC and nmCRPC
• A controllable safety option that supports persistence (continuation rates matter because dose holds or discontinuations reduce follow-on cycles)

Commercial implication: persistence is a quiet driver of market share retention, particularly as multiple ARPIs are available.

3) Geographic rollout and incremental label coverage

International expansion tends to follow:

• EMA/FDA labeling alignment
• Local reimbursement frameworks
• Evidence-based incorporation into local oncology pathways

Commercial implication: growth often comes in waves aligned with reimbursement unlocks, rather than steadily linear adoption.

What is the financial trajectory for darolutamide and what moves the line?

Darolutamide is a Bayer oncology asset. Financial trajectory should be interpreted through two lenses:

1. Product sales growth or stagnation
2. Offsetting effects from competition, pricing, and mix shifts by geography and line

Reported sales and company reporting

Public financial reporting is the primary basis for tracking trajectory. Bayer reports Nubeqa net sales within its pharma segment disclosures.

Indicative direction from public disclosures

• Nubeqa has been among the larger oncology drivers for Bayer in the ARPI category.
• Sales performance typically tracks the ARPI cycle: early ramp after approvals, then moderation under class competition and steady growth driven by expanding patient access and line penetration.

Because precise quarter-by-quarter net sales require the latest Bayer financial tables, only the directionality below is actionable:

• Near-term growth is most sensitive to (i) payer coverage expansion and (ii) persistence and switch rates relative to apalutamide and enzalutamide.
• Mid-term pressure comes from ARPI share reallocation as payers and formularies intensify contract leverage.

Financial mechanics that influence net revenue

Net revenue trajectory for darolutamide is dominated by:

• List price inflation and rebates: list changes may not translate to net price.
• Geographic mix: higher-penetration markets often have greater rebate intensity.
• Patient mix across indications: nmCRPC vs mCRPC can have different treatment durations and uptake timing.

Key business takeaway: the revenue line depends more on payer terms and physician adoption than on drug-level headline efficacy once the market is mature.

Where does darolutamide sit in the payer and provider decision stack?

Provider decision factors

Oncology prescribers weigh:

• Safety and tolerability profile (risk management reduces discontinuations)
• Convenience (dose schedule and monitoring intensity)
• Prior ARPI exposure in the patient history
• Integration with androgen deprivation therapy and sequencing norms

Payer decision factors

Payers weigh:

• Comparative cost-effectiveness against competing ARPIs
• Prior authorization or step therapy requirements
• Budget impact under formulary positioning

What this means for financial trajectory

When payers tighten contracts, volume can still grow, but net sales growth decelerates. When contracts stabilize, growth tends to re-accelerate, especially if physician preference shifts increase persistence.

What are the market risks and upside levers?

Downside risks

• ARPI price competition: higher rebate intensity and contract resets can compress net price.
• Sequencing substitution: physicians may move to other ARPIs based on perceived convenience, insurance coverage, or patient-specific safety.
• Guideline shifts: if later-line chemotherapy strategies or biomarker-driven choices redirect patients away from ARPI sequencing, addressable volume can contract.

Upside levers

• Expanded label or additional patient subgroups: increases total addressable market.
• Improved payer access: lowers friction for initiation and supports sustained monthly volumes.
• Real-world persistence: reduced discontinuation improves treatment exposure and follow-through.

How does darolutamide compare with peer ARPIs from a market perspective?

A useful way to view market dynamics is through class behavior:

Dimension	Darolutamide position	Commercial impact
Competition density	High (multiple ARPIs)	Net price pressure and formulary churn
Treatment longevity	Depends on tolerability and persistence	Sales stability tied to persistence
Uptake driver	Label clarity plus payer acceptance	Growth tied to contracting cycles
Substitution risk	Moderate to high	Volume can shift between ARPIs after contract changes

Business interpretation: in mature ARPI markets, the winner is not only the one with the best headline efficacy, it is the one that maintains payer access and physician preference at sustainable net prices.

What is the likely financial path under current market dynamics?

A practical trajectory forecast for darolutamide is typically shaped as follows:

• Stage 1: ramp and early adoption after label approvals, supported by clinical uptake and access rollouts.
• Stage 2: share competition as peers saturate formularies and contract leverage intensifies.
• Stage 3: stabilization or renewed growth if payer positioning improves, net price stabilizes, and persistence remains strong.

Financial path expectation under mature ARPI conditions: growth tends to become more dependent on patient volume expansion and persistence rather than pure price.

Key Takeaways

• Darolutamide’s market dynamics are dominated by ARPI class competition, with sales performance increasingly driven by payer contracting cycles and physician sequencing behavior.
• Financial trajectory is shaped by net revenue mechanics (rebates, discounts, and mix) more than list price changes.
• Near-term performance hinges on formulary access and persistence relative to apalutamide and enzalutamide.
• Medium-term outcomes will be determined by whether contracting and guideline pathways support share stability or trigger further net price compression.

FAQs

1) What drives darolutamide adoption in nmCRPC and mCRPC?

Payer coverage, sequencing norms, and tolerability/persistence in real-world use shape uptake across nmCRPC and mCRPC. These factors influence both initiation and treatment duration, which drive volume.

2) How does ARPI competition affect darolutamide revenue?

ARPI competition tends to pressure net prices through rebate intensification and contract resets. It also shifts patient flow via formulary placement and prior authorization rules.

3) Why do net sales differ from list price movements?

Because rebate structures, discounts, and contracting terms determine net revenue. In managed oncology markets, list price is not a reliable proxy for what Bayer receives.

4) What is the main business risk for darolutamide?

Sequencing substitution and additional payer pressure that reduces either access (lower initiation) or net price (higher rebates/discounts).

5) What is the main upside lever?

Expanded access that improves initiation rates and stabilizes contracting, combined with persistence that increases treatment exposure.

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References (APA)

[1] Bayer. (n.d.). Nubeqa (darolutamide) prescribing information / product information. Bayer.
[2] U.S. Food and Drug Administration. (n.d.). Nubeqa (darolutamide) label. FDA.
[3] European Medicines Agency. (n.d.). Nubeqa (darolutamide) EPAR. EMA.
[4] Bayer. (n.d.). Financial reports and earnings releases (Nubeqa net sales disclosures). Bayer Investor Relations.