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NUBEQA Drug Patent Profile

When do Nubeqa patents expire, and what generic alternatives are available?

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

This drug has one hundred and twenty-three patent family members in thirty-six 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for NUBEQA

International Patents:	123
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	15
Patent Applications:	121
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

11,168,058

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
NRG Oncology	Phase 2
Celcuity Inc	Phase 1/Phase 2
Mamta Parikh	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 eight US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,168,058.

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	8,975,254		Y	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	11,168,058		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	10,711,013		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	10,835,515		Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	10,383,853			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/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 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

Eurasian Patent Organization

European Patent Office

Japan

Mexico

South Korea

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
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 NUBEQA

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

NUBEQA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nubeqa

Introduction

Nubeqa, also known as darolutamide, is an androgen receptor inhibitor developed by Bayer for the treatment of prostate cancer. The drug has been making significant strides in the pharmaceutical market, particularly in the treatment of non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.

Market Position and Growth

Nubeqa has emerged as the fastest-growing androgen receptor inhibitor in the U.S. market. In 2023, its sales almost doubled, reaching €869 million ($948 million), and Bayer is confident that the drug will achieve blockbuster status in 2024 with projected sales exceeding €1 billion[1][2][3].

Key Drivers of Growth

• Clinical Trial Success: The positive results from the Phase III ARASENS trial, which demonstrated a significant reduction in the risk of death and improvement in key secondary endpoints such as time to metastatic castration-resistant prostate cancer (mCRPC), pain progression, and first symptomatic skeletal event, have been pivotal in driving Nubeqa's growth[4][5].
• Expanding Indications: Bayer is actively pursuing additional indications for Nubeqa, including its use in earlier lines of therapy. The upcoming ARANOTE trial, which evaluates Nubeqa in combination with androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer, is expected to support further growth[1][2].

Financial Performance

Quarterly and Annual Sales

In the second quarter of 2024, Nubeqa's sales grew by 90% on a currency- and portfolio-adjusted basis, contributing significantly to Bayer's pharmaceutical division's 4.5% year-over-year growth. This robust performance helped Bayer's total group sales to climb 3.1% compared to the same quarter in 2023[2][3].

Revenue Projections

Bayer has raised its peak sales expectations for Nubeqa to exceed €3 billion, subject to regulatory approvals and the success of ongoing and planned clinical trials. This projection is based on the drug's strong clinical profile and its potential expansion into various prostate cancer settings between 2027 and 2029[1][5].

Competitive Landscape

Nubeqa operates in a competitive market dominated by other androgen receptor inhibitors. However, its unique clinical profile and the positive outcomes from trials such as ARASENS have positioned it favorably against competitors like Johnson & Johnson's Zytiga (abiraterone). In Japan, for instance, Nubeqa is forecasted to garner significant sales in the metastatic hormone-sensitive prostate cancer market[4].

Strategic Impact on Bayer

Mitigating Patent Exclusivity Loss

The growth of Nubeqa is crucial for Bayer as it prepares to lose patent protection for its anticoagulant medication Xarelto (rivaroxaban) between 2030 and 2034. The success of Nubeqa, along with other new products like Kerendia, is expected to help mitigate the financial impact of this loss[1][2].

Organizational Reorganization

Bayer's strategic focus on Nubeqa is part of a broader organizational reorganization aimed at maximizing efficiency and trimming bureaucracy. The company has streamlined its executive leadership and invested heavily in innovation, including cell and gene therapies, to support the growth of its pharmaceutical division[2][3].

Clinical Development and Future Prospects

Ongoing and Planned Trials

Bayer is conducting several clinical trials to expand Nubeqa's label. The ARANOTE trial, scheduled to report results in 2024, and other trials like ARASTEP and DASL-HiCAP, are expected to provide data that could support the use of Nubeqa in earlier lines of therapy and different patient populations[1][2].

Global Expansion

The approval of Nubeqa in additional markets, such as Japan, further extends its global reach. The drug's approval in Japan for metastatic prostate cancer, based on the ARASENS trial, highlights its potential for significant sales in various international markets[4].

Key Takeaways

• Rapid Growth: Nubeqa is the fastest-growing androgen receptor inhibitor in the U.S., with sales projected to exceed €1 billion in 2024.
• Clinical Success: Positive results from trials like ARASENS have driven Nubeqa's growth and expanded its indications.
• Financial Impact: Nubeqa's success is crucial for Bayer's financial trajectory, particularly in mitigating the loss of patent exclusivity for Xarelto.
• Strategic Focus: Bayer's investment in Nubeqa is part of a broader strategy to enhance innovation and efficiency within its pharmaceutical division.
• Global Expansion: Nubeqa's approval in various markets, including Japan, underscores its global potential.

FAQs

What is Nubeqa and how is it used?

Nubeqa, or darolutamide, is an androgen receptor inhibitor used in the treatment of non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.

How has Nubeqa performed in recent sales?

Nubeqa's sales almost doubled in 2023 to €869 million ($948 million) and are projected to exceed €1 billion in 2024, achieving blockbuster status.

What are the key clinical trials supporting Nubeqa's growth?

The Phase III ARASENS trial and the upcoming ARANOTE trial are significant in supporting Nubeqa's growth and potential label expansions.

How does Nubeqa fit into Bayer's overall strategy?

Nubeqa is a key product in Bayer's pharmaceutical division, helping to mitigate the financial impact of losing patent exclusivity for Xarelto and supporting the company's broader strategic reorganization.

What are the peak sales projections for Nubeqa?

Bayer projects Nubeqa's peak sales to exceed €3 billion, subject to regulatory approvals and the success of ongoing and planned clinical trials.

Sources

1. Biospace: Bayer's Prostate Cancer Drug Nubeqa on Track to Generate Blockbuster Sales in 2024
2. Biospace: Bayer Touts 'Modest' Q2 Performance Amid Sweeping Reorganization
3. Bayer: Modest performance in challenging agricultural market environment – Group outlook confirmed
4. Clinical Trials Arena: Nubeqa approval to boost Bayer's presence in prostate cancer
5. Bayer: Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data