BELINOSTAT - Generic Drug Details

What are the generic drug 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:	55
Patent Applications:	4,907
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

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
Acrotech Biopharma Inc.	Phase 3
H. Lee Moffitt Cancer Center and Research Institute	Phase 2
Pfizer	Phase 2

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

International Patents for BELINOSTAT

Country	Patent Number	Title	Estimated Expiration
Japan	2004511462
South Africa	200710313	Pharmaceutical formulations of HDAC inhibitors
Poland	1901729

BELINOSTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Belinostat

Introduction to Belinostat

Belinostat, marketed under the trade name Beleodaq, is a histone deacetylase (HDAC) inhibitor developed by TopoTarget for the treatment of hematological malignancies and solid tumors. It was specifically approved by the US FDA in July 2014 for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)[2][4].

FDA Approval and Clinical Trials

The FDA approval of belinostat was based on the results of the BELIEF clinical trial, a single-arm, open-label, nonrandomized, international study. This trial involved 129 patients with relapsed or refractory PTCL and demonstrated an overall response rate of 25.8%, including complete and partial responses. The trial's primary end point was the overall response rate, and secondary end points included the duration of response and progression-free and overall survival[2][3].

Market Need and Target Population

Peripheral T-cell lymphomas are a diverse group of non-Hodgkin lymphomas with a poor prognosis, particularly for patients with relapsed or refractory disease. The lack of a standard treatment for these patients created a significant market need, which belinostat aimed to address. The target population includes patients who have failed or are refractory to first-line treatments, a group that experiences high healthcare costs and frequent hospitalizations[2].

Healthcare Costs and Utilization

Patients with PTCL incur substantial healthcare costs. A retrospective cost analysis showed that patients with PTCL had mean annual healthcare costs of $75,934, significantly higher than the $4,661 for matched controls without PTCL. These costs are driven by more frequent hospitalizations, longer hospital stays, and increased use of physician office visits, pharmacy services, emergency department visits, and hospice care[2].

Pricing and Revenue

The financial trajectory of belinostat is influenced by its pricing and the size of the target market. While specific revenue figures for belinostat are not readily available, the drug's pricing can impact its adoption and market share. The cost of belinostat, like other oncology drugs, is typically high, reflecting the complexity and cost of its development and the limited patient population it serves[2].

Competitive Landscape

Belinostat joins other FDA-approved agents for the treatment of relapsed or refractory PTCL, such as pralatrexate and romidepsin. These drugs were also approved under the FDA’s accelerated approval program based on surrogate end points. The competitive landscape is characterized by a small number of treatments for a rare and aggressive type of lymphoma, which can influence pricing strategies and market share[2].

Ongoing Research and Potential Expansion

The safety and efficacy of belinostat are being explored in combination with other therapies, such as the CHOP regimen, for the treatment of newly diagnosed PTCL and B-cell hematologic malignancies. Additionally, belinostat is being evaluated for its activity in solid tumors, including small-cell lung cancer. These ongoing clinical trials could expand the drug's indications and potentially increase its market share and revenue[2][4].

Regulatory Status and Designations

Belinostat has been granted orphan drug and fast track designations by the FDA, which can provide regulatory advantages and expedite the development process. However, as of August 2014, it was not approved in Europe, which could limit its global market reach[4].

Pharmacoeconomic Considerations

The pharmacoeconomic profile of belinostat is crucial for its market dynamics. The drug's manageable toxicity profile and the potential for durable responses make it a valuable option for patients with limited treatment alternatives. However, the high cost of treatment and the need for frequent monitoring and adjustments due to hematologic toxicity can impact its cost-effectiveness and patient access[3].

Adverse Effects and Monitoring

Belinostat is associated with significant adverse effects, including hematologic toxicity such as leukopenia and thrombocytopenia, infections, hepatotoxicity, and gastrointestinal toxicity. Weekly complete blood counts are recommended to monitor and adjust the dosage, which can affect the overall cost of treatment and patient compliance[1][3].

Conclusion

Belinostat represents a significant advancement in the treatment of relapsed or refractory PTCL, offering a new therapeutic option for patients with limited alternatives. Its market dynamics are influenced by its clinical efficacy, manageable toxicity profile, and the high healthcare costs associated with PTCL. Ongoing research into combination therapies and additional indications could further enhance its market position and financial trajectory.

Key Takeaways

• FDA Approval: Belinostat was approved by the FDA in July 2014 for the treatment of relapsed or refractory PTCL.
• Clinical Trials: The BELIEF trial demonstrated an overall response rate of 25.8%, including complete and partial responses.
• Market Need: Belinostat addresses a significant market need for patients with relapsed or refractory PTCL.
• Healthcare Costs: Patients with PTCL incur high healthcare costs, which belinostat can impact through effective treatment.
• Competitive Landscape: Belinostat competes with other FDA-approved agents for PTCL, such as pralatrexate and romidepsin.
• Ongoing Research: Clinical trials are ongoing to explore belinostat's use in combination therapies and solid tumors.
• Regulatory Status: Belinostat has orphan drug and fast track designations but is not approved in Europe as of August 2014.
• Pharmacoeconomic Profile: The drug's manageable toxicity and durable responses make it valuable, but high costs and monitoring needs are considerations.

FAQs

What is belinostat used for?

Belinostat is used for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)[1][2][4].

How is belinostat administered?

Belinostat is administered via intravenous infusion, typically 1000 mg/m² daily for 5 days every 21-day cycle[2][3].

What are the common adverse effects of belinostat?

Common adverse effects include hematologic toxicity (leukopenia, thrombocytopenia), infections, hepatotoxicity, gastrointestinal toxicity, and embryo-fetal toxicity[1][3].

What is the significance of the BELIEF clinical trial?

The BELIEF trial demonstrated the safety and efficacy of belinostat in patients with relapsed or refractory PTCL, leading to its FDA approval[2][3].

Is belinostat approved in Europe?

As of August 2014, belinostat is not approved in Europe[4].

What are the ongoing research areas for belinostat?

Ongoing research includes evaluating belinostat in combination with other therapies for newly diagnosed PTCL and B-cell hematologic malignancies, as well as its activity in solid tumors like small-cell lung cancer[2][4].