Belinostat - Generic Drug Details

What are the generic sources for belinostat and what is the scope of patent protection?

Belinostat is the generic ingredient in one branded drug marketed by Acrotech Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for belinostat. One supplier is listed for this compound.

Summary for belinostat

International Patents:	59
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	58
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for belinostat
What excipients (inactive ingredients) are in belinostat?	belinostat excipients list
DailyMed Link:	belinostat at DailyMed

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

Constraining patent/regulatory exclusivity:

8,835,501

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 belinostat

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE2
Corvus Pharmaceuticals, Inc.	PHASE3
The First Affiliated Hospital with Nanjing Medical University	NA

See all belinostat clinical trials

Pharmacology for belinostat

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for belinostat

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BELINOSTAT

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 belinostat

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	6,888,027		Y	Y
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256-001	Jul 3, 2014		RX	Yes	Yes	8,835,501		Y

International Patents for belinostat

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112498
China	101189003	Pharmaceutical formulations of HDAC inhibitors
South Korea	101329437

Market Dynamics and Financial Trajectory for BELINOSTAT

Last updated: July 30, 2025

Introduction

BELINOSTAT emerges as an innovative pharmaceutical agent positioned within the oncology segment, targeting specific cancer pathways. As a selective inhibitor designed to address unmet medical needs, understanding its market dynamics and financial trajectory is crucial for stakeholders including investors, healthcare providers, and pharmaceutical companies. This analysis explores the competitive landscape, regulatory environment, commercialization prospects, and financial projections surrounding BELINOSTAT.

Market Overview and Therapeutic Landscape

The global oncology market continues to expand, driven by rising cancer incidence, advancements in targeted therapies, and personalized medicine approaches. According to Grand View Research, the global oncology drug market is projected to reach USD 295 billion by 2027, with targeted therapies accounting for a significant and growing share [1].

BELINOSTAT, with its unique mechanism of action, addresses specific molecular pathways implicated in cancers such as solid tumors and hematological malignancies. Its differentiation hinges on selectivity and reduced toxicity compared to traditional chemotherapies, aligning with current trends favoring precision medicine.

Unmet Medical Needs and Patient Demographics

The prevalence of cancers amenable to BELINOSTAT's mechanism is increasing globally. For instance, lung, breast, and colorectal cancers demonstrate significant overlap with the pathways targeted by BELINOSTAT. Patients with treatment-resistant or metastatic disease represent a high-value subgroup, driving demand for novel agents with improved efficacy and safety.

Competitive Landscape

Existing and Pipeline Drugs

The competitive landscape features established targeted therapies such as kinase inhibitors and monoclonal antibodies. Drugs like Erlotinib, Imatinib, and newer agents like Lenvatinib occupy significant market shares. BELINOSTAT's success depends on its clinical advantages, such as superior efficacy, tolerability, or overcoming resistance.

Intellectual Property and Patents

Patent protection forms a cornerstone of BELINOSTAT's market exclusivity. Securing robust patent protection, including composition of matter and method of use patents, will influence its lifecycle and revenue potential. Any challenges to patents or patent cliffs could impact long-term profitability.

Regulatory Environment

Regulatory approval is pivotal, with agencies like the FDA and EMA rigorously assessing safety, efficacy, and quality. Fast-track designations or orphan drug status could accelerate market entry and provide market exclusivity extensions, directly affecting financial trajectory. Conversely, failure to demonstrate clinical benefit may delay approval, dampening revenue prospects.

Commercialization Strategy

Effective commercialization involves strategic alliances, pricing frameworks, and market access pathways. Early engagement with healthcare systems and payers can facilitate reimbursement strategies, essential for revenue realization. Additionally, leveraging companion diagnostics to identify target patient populations enhances adoption rates.

Pricing and Reimbursement

Pricing strategies must align with therapeutic value propositions and competitive positioning. High-cost drugs often face reimbursement hurdles; therefore, demonstrating cost-effectiveness through health economic analyses is essential to secure favorable reimbursement terms.

Manufacturing and Supply Chain

Scaling manufacturing capacity ensures supply continuity amid high demand. Quality control and cost management are critical to safeguarding margins and meeting regulatory standards.

Financial Trajectory and Revenue Projections

Initial Investment and Development Costs

Development costs for BELINOSTAT include preclinical studies, clinical trials (Phase I-III), regulatory submissions, and initial commercialization. Industry averages suggest a median R&D expenditure exceeding USD 2.6 billion per approved drug [2].

Revenue Streams and Market Penetration

Assuming successful regulatory approval, BELINOSTAT's revenue trajectory hinges on market penetration, pricing strategies, and competition:

• Year 1-2: Limited revenue during initial launch; focus on establishing proof of efficacy and safety.
• Year 3-5: Growing adoption, especially if post-approval real-world evidence supports improved outcomes.
• Year 6+: Market saturation, potential entry of generics post-patent expiry, impacting revenue.

Cost Considerations and Profitability

Manufacturing costs, marketing, and post-marketing surveillance contribute to operational expenses. Achieving a break-even point typically occurs within 3-5 years post-launch, pending market reception and reimbursement success.

Future Growth Drivers

• Combination therapies: Incorporation with other agents could expand usage.
• Expanded indications: Label expansions based on new clinical data increase revenue streams.
• Global expansion: Penetrating emerging markets offers additional growth opportunities.

Risks and Challenges

Key risks include clinical failure, regulatory delays, pricing and reimbursement hurdles, and competitive entry. Patent challenges or biosimilar interference could reduce market exclusivity. Additionally, healthcare policy shifts towards cost containment impact pricing flexibility.

Regulatory and Market Entry Timelines

Timeliness of regulatory approval impacts financial outlook. Typically, late-stage clinical success coupled with strategic market entry accelerates revenue realization. As of now, anticipated approval timelines for BELINOSTAT depend on ongoing trial data and regulatory review processes.

Conclusion

BELINOSTAT presents a compelling addition to the targeted oncology therapeutics landscape, with promising market potential contingent on clinical efficacy and successful navigation of regulatory and commercial pathways. Investors and stakeholders must weigh the drug’s developmental phase, competitive positioning, and potential for expansion in the oncology market.

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Key Takeaways

• BELINOSTAT operates within a rapidly expanding oncology market favored by personalized medicine trends.
• Successful patent protection, clear clinical benefits, and strategic partnerships are vital to maximizing revenue.
• Regulatory designations and market access strategies significantly influence the drug’s financial trajectory.
• Early clinical trials and positive real-world evidence will be critical to accelerating adoption and revenue growth.
• Long-term profitability hinges on navigating competitive pressures, patent protections, and global expansion.

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FAQs

1. What are the primary therapeutic indications for BELINOSTAT?
   BELINOSTAT targets specific molecular pathways implicated in cancers such as solid tumors and hematologic malignancies, particularly where resistance to current therapies presents a challenge.

2. How does BELINOSTAT differentiate itself from existing targeted therapies?
   Its selectivity and safety profile offer potential advantages over traditional kinase inhibitors, potentially improving efficacy and reducing adverse effects.

3. What are the key regulatory milestones for BELINOSTAT?
   Clinical trial completion, submission of regulatory dossiers to agencies like the FDA and EMA, and obtaining approval or expedited designations such as orphan or fast-track status.

4. What factors will influence BELINOSTAT’s market penetration?
   Efficacy demonstrated in clinical trials, reimbursement negotiations, physician adoption, and competition from existing therapies or biosimilars.

5. What are potential challenges facing BELINOSTAT’s commercial success?
   Clinical trial failures, regulatory setbacks, patent challenges, high development costs, and competitive market entry may impede its financial trajectory.

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Sources

1. Grand View Research. Oncology Drugs Market Size & Trends Analysis [2022].
2. DiMasi, J. A., et al. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016;47:20-33.