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BELEODAQ Drug Patent Profile

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

Beleodaq is a drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in twenty-seven countries.

The generic ingredient in BELEODAQ is belinostat. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the belinostat profile page.

DrugPatentWatch^® Generic Entry Outlook for Beleodaq

Beleodaq was eligible for patent challenges on July 3, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 27, 2027. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 BELEODAQ

International Patents:	59
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	17
Patent Applications:	1,831
Drug Prices:	Drug price information for BELEODAQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELEODAQ
What excipients (inactive ingredients) are in BELEODAQ?	BELEODAQ excipients list
DailyMed Link:	BELEODAQ at DailyMed

See drug prices for BELEODAQ

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

NDA:

206256

Dosage:

POWDER;INTRAVENOUS

^*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 BELEODAQ

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

Sponsor	Phase
Acrotech Biopharma Inc.	Phase 3
University of Utah	Phase 1
Mayo Clinic	Phase 1

See all BELEODAQ clinical trials

Pharmacology for BELEODAQ

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Paragraph IV (Patent) Challenges for BELEODAQ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELEODAQ	Injection	belinostat	500 mg/vial	206256	1	2018-07-03

US Patents and Regulatory Information for BELEODAQ

BELEODAQ is protected by two US patents.

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
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes			Y	Y
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes			Y

International Patents for BELEODAQ

When does loss-of-exclusivity occur for BELEODAQ?

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

Australia

Austria

Brazil

Canada

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Africa

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 BELEODAQ around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2004511462
South Africa	200710313	Pharmaceutical formulations of HDAC inhibitors
Poland	1901729
Ukraine	99810	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, КОТОРЫЕ СОДЕРЖАТ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ;ФАРМАЦЕВТИЧНІ СКЛАДИ, ЩО МІСТЯТЬ ІНГІБІТОРИ ДЕАЦЕТИЛАЗИ ГІСТОНІВ (PHARMACEUTICAL FORMULATIONS OF HISTONE DEACETYLASE INHIBITORS)

BELEODAQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BELEODAQ (Belinostat)

Introduction to BELEODAQ

BELEODAQ (belinostat) is a prescription medicine developed by Acrotech Biopharma, used to treat adults with peripheral T-cell lymphoma (PTCL) that has relapsed or does not respond to previous treatments. PTCL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), accounting for approximately 10%-15% of all NHL cases[1][4].

Regulatory Approval and Market Access

BELEODAQ received accelerated approval from the US Food and Drug Administration (FDA) in July 2014 for the treatment of PTCL. This approval was a significant milestone, highlighting the drug's potential in addressing a critical unmet medical need[4].

In Europe, Middle East, North Africa, Russia, and the CIS, IDEOGEN Group's Managed Access division has taken over the Special Access Program for BELEODAQ, ensuring its availability for patients in these regions. This program allows physicians to access the drug for special circumstances when alternative treatment options are required[1].

Market Dynamics

Unmet Medical Needs and Market Opportunity

The market for BELEODAQ is driven by the high unmet need for effective treatments for PTCL. Given the rarity and aggressiveness of PTCL, there is a significant demand for therapies that can offer improved outcomes for patients. The drug's approval and subsequent market access programs have filled a critical gap in the treatment landscape[1][4].

Competitive Landscape

The HDAC inhibitor market, to which BELEODAQ belongs, is highly competitive and dynamic. Several companies, including Xynomic Pharma, Medivir, Regency Pharmaceuticals, and Tenaya Therapeutics, are developing novel HDAC inhibitors. This competition fosters innovation but also presents challenges such as market fragmentation and pricing pressures[4].

Emerging Treatments and Pipeline Activity

The HDAC inhibitor market is expected to grow significantly due to the expanding pipeline activity and the increasing incidence of cancer indications. BELEODAQ, along with other HDAC inhibitors like Abexinostat, Remetinostat, and Ricolinostat, is part of this growing market. The constant quest for more effective and safer drugs drives this growth, with researchers and pharmaceutical companies working tirelessly to develop new therapies[4].

Financial Performance

Sales and Revenue

Historical financial data shows that BELEODAQ has generated significant revenue. For example, in the second quarter of 2018, BELEODAQ net sales were $2.7 million, and by the fourth quarter of 2018, this figure had increased to $3.7 million[2][5].

Operating Costs and Expenses

The financial performance of companies associated with BELEODAQ, such as Spectrum Pharmaceuticals, has been influenced by various operating costs. These include selling, general, and administrative expenses, research and development costs, and amortization of intangible assets. For instance, in 2018, Spectrum Pharmaceuticals reported total operating costs and expenses of $71.98 million, with a significant portion attributed to research and development[2][5].

Net Income and Loss

The net income and loss figures for companies involved with BELEODAQ have been variable. In the second quarter of 2018, Spectrum Pharmaceuticals reported a net loss of $20.85 million, while in the fourth quarter, the net loss was $49.22 million. These figures reflect the challenges and investments associated with developing and commercializing specialized therapies[2][5].

Future Outlook

Growth Projections

The HDAC inhibitor market, including BELEODAQ, is anticipated to experience significant growth. DelveInsight's analysis projects a remarkable growth trajectory for the HDAC inhibitor market between 2020 and 2034, driven by increasing incidence, heightened awareness, and expanding pipeline activity for cancer indications[4].

Regulatory and Market Factors

Regulatory factors play a crucial role in the market dynamics of HDAC inhibitors. The approval process for these drugs is complex, with regulatory bodies closely scrutinizing safety and efficacy data. As the understanding of these inhibitors deepens, regulatory agencies are updating their guidelines and requirements, impacting development timelines and market entry strategies[4].

Key Takeaways

• Market Need: BELEODAQ addresses a critical unmet need for effective treatments in PTCL.
• Regulatory Approval: Accelerated FDA approval in 2014 and Special Access Programs in various regions.
• Competitive Landscape: Part of a competitive HDAC inhibitor market with several emerging treatments.
• Financial Performance: Significant revenue generation but also high operating costs and variable net income/loss figures.
• Future Outlook: Anticipated growth in the HDAC inhibitor market driven by increasing incidence and pipeline activity.

FAQs

What is BELEODAQ used for?

BELEODAQ (belinostat) is used to treat adults with peripheral T-cell lymphoma (PTCL) that has relapsed or does not respond to previous treatments.

Who approved BELEODAQ?

BELEODAQ received accelerated approval from the US Food and Drug Administration (FDA) in July 2014.

What is the competitive landscape like for BELEODAQ?

The HDAC inhibitor market, to which BELEODAQ belongs, is highly competitive with several companies developing novel HDAC inhibitors.

How has the financial performance of BELEODAQ been?

BELEODAQ has generated significant revenue, but companies associated with it have reported variable net income and loss figures due to high operating costs.

What is the future outlook for the HDAC inhibitor market?

The HDAC inhibitor market, including BELEODAQ, is anticipated to experience significant growth between 2020 and 2034 driven by increasing incidence and pipeline activity.

Sources

1. Swiss Pharma Company - IDEOGEN takes over Special Access Program for BELEODAQ® (belinostat) - PR Newswire
2. Spectrum Pharmaceuticals Reports Second Quarter 2018 Financial Results and Pipeline Update - BioSpace
3. Citius Oncology, Inc. Presentation - Citius Oncology
4. HDAC Inhibitor Market to Observe Stunning Growth During the Study Period 2020-2034 - GlobeNewswire
5. Spectrum Pharmaceuticals Reports Fourth Quarter 2018 and Full-Year 2018 Financial Results and Pipeline Update - BioSpace