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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Darolutamide has one hundred and twenty-three patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for darolutamide

International Patents:	123
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	62
Patent Applications:	363
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
NRG Oncology	Phase 2
Eli Lilly and Company	Phase 1
Celcuity Inc	Phase 1/Phase 2

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	10,010,530			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	8,975,254		Y	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	11,046,713			Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	11,168,058		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/004790 NUBEQA 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
Spain	2877248
South Africa	200806874
Japan	2020510018	結晶性医薬品の製造
New Zealand	598747
Lithuania	3250554
China	101410016
Israel	218586	קרבוקסאמידים רב-טבעתיים של אזולים ותכשירי רוקחות המכילים אותם (Polycyclic azole carboxamides and pharmaceutical compositions comprising them)

Supplementary Protection Certificates for darolutamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1986495	33/2019	Austria		PRODUCT NAME: SEDAXAN ODER EIN TAUTOMER DAVON, FLUDIOXONIL UND METALAXYL M; NAT. REGISTRATION NO/DATE: 3979-0 20181130; FIRST REGISTRATION: NL 29317 20171229
2493858	PA2020514	Lithuania		PRODUCT NAME: DAROLUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 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
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	PA2020514,C2493858	Lithuania		PRODUCT NAME: DAROLUTAMIDAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327

Darolutamide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Darolutamide (Nubeqa)

Introduction

Darolutamide, marketed as Nubeqa, is a significant player in the treatment of prostate cancer, particularly in the nonmetastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) settings. This article delves into the market dynamics and financial trajectory of darolutamide, highlighting its efficacy, cost-effectiveness, market share, and future prospects.

Efficacy and Clinical Outcomes

Darolutamide has demonstrated robust clinical outcomes in various trials. In the ARAMIS trial, it showed a significant improvement in metastasis-free survival (MFS) and overall survival when combined with androgen deprivation therapy (ADT) in patients with nmCRPC[5].

Lower Rates of Discontinuation and Progression

Studies such as the DEAR study have shown that darolutamide is associated with lower rates of treatment discontinuation and progression to metastatic disease compared to other androgen receptor inhibitors like enzalutamide and apalutamide[2].

PSA Progression and Radiological Outcomes

The combination of ADT and darolutamide has been associated with lower rates of PSA progression and radiological progression. Patients achieving PSA levels of less than 0.2 ng/mL had a significantly lower risk of radiological progression[5].

Cost-Effectiveness and Economic Analysis

The cost-effectiveness of darolutamide is a critical factor in its market dynamics.

Cost Structure

Darolutamide is priced at $28.34 per tablet, leading to a 28-day cost of $3,175. This is comparable to other treatments like apalutamide and enzalutamide but significantly higher than some other comparators like docetaxel and abiraterone[1].

Incremental Cost-Effectiveness Ratio (ICER)

In a cost-utility analysis, darolutamide plus docetaxel and ADT was found to be more costly and more effective than abiraterone and ADT, resulting in an ICER of $156,172 per quality-adjusted life-year (QALY). For darolutamide to be cost-effective at a $50,000-per-QALY threshold, a price reduction of 58% would be required[1].

Market Share and Utilization

Darolutamide has been gaining traction in the market.

Increasing Market Share

The market share of darolutamide has increased significantly, from 3.6% in the first year to 18% in the fifth year, indicating growing acceptance and adoption by healthcare providers[4].

Patient Population

The drug is indicated for patients with mCSPC eligible for chemotherapy, aligning with the eligibility criteria for the ARASENS clinical trial. This targeted approach helps in maximizing its market potential within the specified patient population[1].

Financial Trajectory

The financial trajectory of darolutamide is influenced by several factors, including its clinical efficacy, cost-effectiveness, and market competition.

Revenue Growth

Bayer, the manufacturer of darolutamide, has identified prostate cancer as a key focus area and expects Nubeqa to be a significant growth driver. The growing clinical evidence and expanding indications are likely to drive revenue growth for the drug[3].

Investment in Research and Development

Bayer is investing heavily in the development of darolutamide, with ongoing trials like the ARASTEP trial and the REASSURE study. These investments aim to further establish darolutamide's efficacy and safety across different stages of prostate cancer, potentially expanding its market reach[3].

Competitive Landscape

Darolutamide operates in a competitive landscape with other androgen receptor inhibitors.

Comparison with Other Treatments

Darolutamide has been compared to treatments like enzalutamide, apalutamide, and abiraterone. While it offers similar efficacy, its tolerability and lower rates of discontinuation due to adverse effects are notable advantages[2].

Market Differentiation

The drug's ability to delay disease progression, extend survival, and preserve quality of life differentiates it from other treatments. This differentiation is crucial for maintaining and growing its market share[3].

Future Prospects

The future prospects of darolutamide look promising, driven by ongoing research and expanding indications.

Expanding Indications

Bayer is assessing the potential of darolutamide in earlier disease stages, which could significantly broaden its market. The ongoing trials and studies are expected to provide further evidence of its efficacy and safety[3].

Regulatory Approvals

The FDA approval of darolutamide in the nmCRPC setting has been a significant milestone. Future regulatory approvals in other indications will be crucial for its continued market growth[5].

Key Takeaways

• Efficacy: Darolutamide has demonstrated significant clinical benefits in delaying disease progression and improving survival in prostate cancer patients.
• Cost-Effectiveness: While costly, darolutamide requires substantial price reductions to be considered cost-effective compared to some competitors.
• Market Share: The drug's market share is increasing, driven by its clinical advantages and targeted marketing.
• Financial Trajectory: Revenue growth is expected due to expanding indications and ongoing investments in research and development.
• Competitive Landscape: Darolutamide differentiates itself through better tolerability and lower discontinuation rates.

FAQs

What is the current market share of darolutamide?

Darolutamide's market share has increased from 3.6% in the first year to 18% in the fifth year, indicating growing acceptance and adoption[4].

How does darolutamide compare to other androgen receptor inhibitors in terms of discontinuation rates?

Darolutamide is associated with lower rates of treatment discontinuation compared to enzalutamide and apalutamide, with a lower proportion of patients discontinuing due to adverse effects[2].

What are the key factors influencing the cost-effectiveness of darolutamide?

The cost-effectiveness of darolutamide is influenced by its high cost, the need for significant price reductions to meet cost-effectiveness thresholds, and its incremental benefits over comparators[1].

What are the future prospects for darolutamide in terms of expanding indications?

Bayer is currently assessing the potential of darolutamide in earlier disease stages, which could significantly broaden its market and drive future growth[3].

How does darolutamide impact PSA progression and radiological outcomes?

The combination of ADT and darolutamide is associated with lower rates of PSA progression and radiological progression, particularly in patients achieving PSA levels of less than 0.2 ng/mL[5].

Sources

1. Pharmacoeconomic Review - Darolutamide (Nubeqa) - NCBI
2. Darolutamide Associated With Lower Rates of Treatment Discontinuation and Disease Progression in nmCRPC - OncLive
3. Digging Deeper Into Bayer's ASCO GU Presentation - PharmExec
4. Budget impact analysis of darolutamide for treatment of nonmetastatic castration-resistant prostate cancer - RTIHS
5. ADT Plus Darolutamide Is Associated With Lower Rates of PSA Progression in nmCRPC - OncLive