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:	59
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
Dizal Pharmaceuticals	PHASE3

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
European Patent Office	2494969	Formulations pharmaceutiques d'inhibiteurs de HDAC (Pharmaceutical formulations of HDAC inhibitors)
Portugal	1328510
South Korea	101340824
Spain	2540204
Japan	4975941

Market Dynamics and Financial Trajectory of BELINOSTAT

Last updated: February 27, 2026

What is the current approval status and clinical development phase?

BELINOSTAT is an experimental drug candidate under development by a biopharmaceutical company known for its focus on cancer therapies. As of 2023, it remains in phase 2 clinical trials, primarily targeting solid tumors, with no approval granted for commercial sale outside clinical settings.

Who are the primary competitors and alternative therapies?

Key competitors in the same target space include:

• PARP inhibitors: Olaparib, niraparib, rucaparib (approved for ovarian, breast, prostate cancers).
• Other novel agents: Drugs targeting DNA damage response pathways under clinical evaluation, such as ATR and ATM inhibitors.

The market for DNA repair pathway inhibitors is expanding, driven by increasing indications across oncology.

What are the market size estimates?

The global oncology drug market was valued at approximately $175 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of 7.9% to reach $298 billion by 2028 (Market Research Future, 2023).

Specific to DNA repair inhibitors, current revenue estimates are around $5 billion annual sales, driven by approved PARP inhibitors. BELINOSTAT's potential share depends on clinical efficacy, safety profile, and regulatory outcomes.

How does regulatory landscape influence potential revenue?

• FDA and EMA pathways: Breakthrough therapy designation, accelerated approval, or priority review can expedite market entry.
• Regulatory hurdles: Confirmatory Phase 3 trials are required for full approval, which may extend timelines.
• Data submission and approval timelines: Average FDA approval for oncology drugs takes approximately 10-12 years from Phase 1 initiation; accelerated programs can reduce this to 6-8 years.

What are the financial projections based on current development data?

Given the drug's Phase 2 status, the following projections are tentative, based on typical development costs, market penetration assumptions, and competitive landscape:

Parameter	Assumption	Detail
Development costs (per phase)	$200 million to $300 million	Estimated cumulative costs up to Phase 2
Cost of Phase 3 trials	$400 million to $600 million	Large-scale, multicenter trials required
Time to market	4-6 years after Phase 2 completion	Assuming successful trial results
Peak annual revenue (per indication)	$500 million to $1 billion	Based on comparable PARP inhibitors
Market share after approval	10-20% of targeted indication population	Varies per indication; initial market penetration unlikely to be immediate

Revenue scenarios

Scenario	Assumed Year of Launch	Approximate Peak Revenue	Market Share	Key Factors impacting success
Conservative	Year 2028	$300 million	10%	Clinical trial results, regulatory approval delays
Moderate	Year 2029	$600 million	15%	Positive trial data, effective competitive positioning
Optimistic	Year 2027	$1 billion	20%	Fast regulatory approval, significant unmet needs

Market penetration and adoption considerations

• Unmet medical need: BELINOSTAT targets cancers with limited treatment options, which could accelerate adoption if proven effective.
• Pricing strategies: Could range between $50,000 and $100,000 per patient annually for targeted therapies.
• Reimbursement landscape: Payer acceptance depends on demonstrated cost-effectiveness and clinical benefit.

Risks impacting financial trajectory

• Clinical failure: Any lack of efficacy or safety concerns could halt development or reduce market potential.
• Regulatory delays: Lengthen time to market and increase costs.
• Competitive advances: New therapies entering the space can limit market share.
• Market access barriers: High drug prices and reimbursement issues can restrict sales.

Summary of key insights

• BELINOSTAT remains in mid-stage development with uncertainty about trial outcomes.
• The potential market size is comparable to existing DNA repair inhibitors, with peak revenues estimated between $300 million and $1 billion.
• Developments in trial results, regulatory pathways, and competitive landscape will significantly influence financial outcomes.
• Investment risk remains high until Phase 3 data is available and regulatory approval is secured.

Key Takeaways

• BELINOSTAT is in Phase 2 clinical development with no current commercial availability.
• The potential market for DNA repair inhibitors is expanding, but competition from established drugs exists.
• Financial projections depend heavily on successful late-phase trials, regulatory approval, and market adoption.
• Risks include trial failure, regulatory delays, and emerging competitive therapies.
• Realistic revenue estimates suggest modest initial market penetration, increasing with trial success and market acceptance.

FAQs

1. What are the main challenges facing BELINOSTAT’s development?

Clinical efficacy and safety are uncertain until Phase 3 trials. Regulatory approval depends on successful demonstration of benefit. Competition from existing therapies may limit market share.

2. How long could it take for BELINOSTAT to reach the market?

Approximately 4-6 years after successful Phase 2 trials, depending on trial outcomes, regulatory review duration, and potential accelerated pathways.

3. What factors could improve BELINOSTAT’s commercial prospects?

Favorable trial results showing superior efficacy, an accelerated regulatory process, unmet medical needs in targeted indications, and favorable pricing and reimbursement terms.

4. How sensitive are revenue estimates to clinical outcomes?

Highly sensitive. A positive Phase 3 trial could catalyze high revenue, whereas failure could eliminate commercial prospects.

5. What is the outlook for investment in BELINOSTAT?

High risk due to early-stage development, but potential rewards exist if clinical outcomes demonstrate significant benefit, leading to market entry within 4-6 years.

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[1] Market Research Future. (2023). Oncology drugs market forecast.