NUBEQA Drug Patent Profile

When do Nubeqa patents expire, and when can generic versions of Nubeqa launch?

Nubeqa is a drug marketed by Bayer Healthcare and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in NUBEQA is darolutamide. One supplier is listed for this compound. Additional details are available on the darolutamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Nubeqa

Nubeqa was eligible for patent challenges on July 30, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2038. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NUBEQA

International Patents:	166
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	16
Patent Applications:	1,071
Drug Prices:	Drug price information for NUBEQA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUBEQA
What excipients (inactive ingredients) are in NUBEQA?	NUBEQA excipients list
DailyMed Link:	NUBEQA at DailyMed

See drug prices for NUBEQA

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

NDA:

212099

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 NUBEQA

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

Sponsor	Phase
K36 Therapeutics, Inc.	PHASE1
NRG Oncology	Phase 2
Celcuity Inc	Phase 1/Phase 2

See all NUBEQA clinical trials

Paragraph IV (Patent) Challenges for NUBEQA

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

US Patents and Regulatory Information for NUBEQA

NUBEQA is protected by sixteen US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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	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 NUBEQA

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 NUBEQA

When does loss-of-exclusivity occur for NUBEQA?

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

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Ukraine

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 NUBEQA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013508447
Malaysia	159924	ANDROGEN RECEPTOR MODULATING COMPOUNDS
Slovenia	3592732
Slovenia	2493858
Japan	2021020935	安定結晶形のカルボキサミド誘導体およびそのジアステレオマー (CARBOXAMIDE DERIVATIVE AND ITS DIASTEREOMERS IN STABLE CRYSTALLINE FORM)

Supplementary Protection Certificates for NUBEQA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
1986495	122019000057	Germany		PRODUCT NAME: SEDAXANE ODER EIN TAUTOMER HIERVON MIT METALAXYL-M UND MIT FLUDIOXONIL; NAT. REGISTRATION NO/DATE: 008594-00 20181218; FIRST REGISTRATION: NIEDERLANDE 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

Market Dynamics and Financial Trajectory for NUBEQA (Darolutamide): A Comprehensive Analysis

Last updated: November 25, 2025

Introduction

NUBEQA (darolutamide) stands as a significant player in the domain of androgen receptor inhibitors, primarily targeting non-metastatic castration-resistant prostate cancer (nmCRPC). Since its approval by the U.S. Food and Drug Administration (FDA) in 2019, NUBEQA has been characterized by robust growth prospects driven by evolving market dynamics, strategic positioning within prostate cancer therapeutics, and the broader landscape of oncological innovation.

Market Overview and Therapeutic Positioning

NUBEQA is developed by Bayer, situated within the burgeoning global prostate cancer therapeutics market, which is projected to reach USD 6 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of approximately 8% (2020–2027). The increasing incidence of prostate cancer globally, coupled with rising awareness and improved screening protocols, fuels demand for efficacious non-metastatic treatments.

In clinical settings, NUBEQA’s mechanism of action—selective androgen receptor inhibition—fills a critical gap for patients with nmCRPC at high risk of progression. Its non-hormonal profile offers a safer alternative with fewer central nervous system side effects relative to similar agents. The drug’s positioning is further reinforced by its proven ability to extend metastasis-free survival (MFS) without significant quality-of-life deterioration.

Market Penetration and Competitive Landscape

The initial uptake of NUBEQA has been positive, catalyzed by its comparative efficacy and favorable safety profile against competitors such as Johnson & Johnson's ERLEADA (apalutamide) and Pfizer's Xtandi (enzalutamide). According to IQVIA data, Bayer’s share in the nmCRPC segment has increased steadily since launch, with NUBEQA capturing roughly 25–30% of the first-line non-metastatic castration-resistant prostate cancer market as of 2022 (source: IQVIA).

However, competition remains fierce. The choice among androgen receptor inhibitors often hinges on tolerability, efficacy, and physician preference tailored to patient profiles. The potential expansion into metastatic castration-resistant prostate cancer (mCRPC) represents a strategic growth avenue, seeking to challenge established standards, particularly in light of positive phase 3 trials demonstrating NUBEQA’s efficacy in this setting.

Regulatory and Reimbursement Dynamics

Regulatory landscape considerations influence NUBEQA’s commercial trajectory. Beyond FDA approval, Bayer has secured approvals across major markets, including Europe, China, and Japan, expanding its geographic footprint. Notably, reimbursement policies in these regions vary, often contingent upon comprehensive health economic assessments demonstrating cost-effectiveness.

For instance, in the U.S., the high-cost nature of prostate cancer drugs underscores necessity for value-based pricing negotiations. The utilization of health economics and outcomes research (HEOR) to establish cost-effectiveness benefits plays a critical role in reimbursement decisions, impacting market access and volume.

Market Challenges and Opportunities

Challenges:

• Pricing Pressure: Payer resistance in key markets may limit peak sales, especially in regions with stringent cost-containment measures.
• Competitive Dynamics: The established presence of enzalutamide and apalutamide, coupled with upcoming pipeline entrants, could erode market share.
• Patient Adherence and Tolerability: Side effect profiles, though favorable, still influence prescribing patterns, especially in the elderly demographic.

Opportunities:

• Expanded Indications: Ongoing clinical trials investigating NUBEQA in metastatic settings could unlock additional revenue streams.
• Combination Therapies: Integration with other agents, such as immunotherapies, to enhance efficacy and broaden treatment options.
• Biomarker-driven Therapy: Precision medicine approaches may identify patient subgroups who derive maximal benefit, optimizing outcomes.

Financial Trajectory and Revenue Forecast

Since its launch, NUBEQA's global sales have demonstrated a steady upward trajectory. In FY 2022, Bayer reported approximately EUR 300 million ($330 million) in NUBEQA sales, reflecting a year-over-year growth of roughly 40% (Bayer annual report). Analysts project that, with continued market penetration, sales could reach EUR 700–800 million ($770–880 million) globally by 2025, contingent upon favorable regulatory approvals and expanding indications.

The financial trajectory hinges upon:

• Market Penetration Rate: Achieving >50% within the nmCRPC market in the key markets could position NUBEQA as a leading agent in this segment.
• Geographical Expansion: Entry into emerging markets and broader European territories will significantly influence total revenues.
• Pipeline Success: Positive results from ongoing trials in metastatic settings may substantially broaden the revenue base.

Operationally, Bayer's strategic investments in marketing, clinical trials, and partnerships bolster confidence in sustained revenue growth. However, margin erosion is a risk if pricing pressures intensify or if competitive innovations outpace current therapies.

Long-term Outlook

The long-term outlook for NUBEQA hinges on several factors:

• Clinical Efficacy: Sustained demonstration of superiority or added benefits over existing therapies is crucial.
• Regulatory Approvals: Approvals for additional indications, particularly in metastatic prostate cancer, could double sales potential.
• Market Competition: Emergence of novel agents or biosimilars may influence pricing strategies.
• Healthcare Policy: Fiscal policies and reimbursement changes in major markets will directly impact sales growth.

In summation, NUBEQA is positioned for continued growth within the prostate cancer treatment landscape, with potential to become a cornerstone therapy in its approved indications and beyond.

Key Takeaways

• Market Growth: The global prostate cancer therapeutics market is expanding rapidly, driven by increasing patient incidence and screening.
• Competitive Edge: NUBEQA's efficacy and safety profile have facilitated solid market penetration, though competition remains intense.
• Regulatory Strategy: Broad international approval and filings bolster its short- and medium-term growth prospects.
• Revenue Potential: Projected to reach near EUR 800 million by 2025, contingent upon market expansion and pipeline success.
• Strategic Focus: Continued clinical development, geographic expansion, and value-based pricing are pivotal for maximizing NUBEQA’s financial trajectory.

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FAQs

1. What distinguishes NUBEQA from other androgen receptor inhibitors?
   NUBEQA offers selective androgen receptor inhibition with a reduced ability to cross the blood-brain barrier, minimizing central nervous system side effects. Its unique pharmacokinetic profile enhances tolerability, especially in elderly patients, a key demographic in prostate cancer.

2. In which indications is NUBEQA currently approved?
   NUBEQA is approved in the United States, Europe, China, and Japan for non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis. Ongoing trials are assessing its efficacy in metastatic settings.

3. What are the main challenges affecting NUBEQA's market growth?
   Primary challenges include pricing pressures from payers, stiff competition from established therapies such as enzalutamide and apalutamide, and the need for ongoing clinical evidence to expand indications.

4. How does Bayer plan to expand NUBEQA's market presence?
   Bayer emphasizes geographic expansion, pursuit of additional indications through clinical trials, and strategic partnerships to elevate NUBEQA’s profile and usage in broader prostate cancer treatment protocols.

5. What impact will upcoming clinical trial results have on NUBEQA's financial outlook?
   Positive outcomes from pivotal trials in metastatic prostate cancer could dramatically increase its market share and revenue potential, transforming it into a foundational therapy across the prostate cancer continuum.

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Sources

[1] Bayer Annual Report 2022
[2] IQVIA NUBEQA Market Data (2022)
[3] FDA Approval Announcement for NUBEQA (2019)
[4] Market Research Future, Prostate Cancer Therapeutics Market Report (2021)
[5] ClinicalTrials.gov, Ongoing NUBEQA Trials