ZOLINZA Drug Patent Profile

Which patents cover Zolinza, and what generic alternatives are available?

Zolinza is a drug marketed by Msd Sub Merck and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and thirty-one patent family members in thirty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Zolinza

Zolinza was eligible for patent challenges on October 6, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 11, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZOLINZA

International Patents:	131
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	161
Patent Applications:	4,790
Drug Prices:	Drug price information for ZOLINZA
What excipients (inactive ingredients) are in ZOLINZA?	ZOLINZA excipients list
DailyMed Link:	ZOLINZA at DailyMed

See drug prices for ZOLINZA

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

NDA:

021991

Dosage:

CAPSULE;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 ZOLINZA

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

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 1
Prospect Creek Foundation	Phase 1
Oregon Health and Science University	Phase 1

See all ZOLINZA clinical trials

Pharmacology for ZOLINZA

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

US Patents and Regulatory Information for ZOLINZA

ZOLINZA is protected by four 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
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes			Y
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes

Expired US Patents for ZOLINZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006

International Patents for ZOLINZA

When does loss-of-exclusivity occur for ZOLINZA?

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

Morocco

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 ZOLINZA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2008519081
World Intellectual Property Organization (WIPO)	9307148
South Korea	100924737

Market Dynamics and Financial Trajectory for ZOLINZA (vorinostat)

Last updated: July 28, 2025

Introduction

ZOLINZA (vorinostat) is an oral histone deacetylase (HDAC) inhibitor primarily used to treat certain types of T-cell lymphoma, notably cutaneous T-cell lymphoma (CTCL). Developed by Merck & Co., ZOLINZA was approved by the FDA in 2006, representing a significant milestone in epigenetic cancer therapies. Understanding its market dynamics and financial trajectory involves assessing current therapeutic landscapes, competitive positioning, regulatory developments, and commercial performance.

Market Overview and Therapeutic Context

ZOLINZA operates within a specialized market segment of oncology therapeutics, targeting patients with relapsed or refractory CTCL. The global oncology drugs market is projected to reach over USD 250 billion by 2025, driven by increasing cancer incidence, advances in precision medicine, and expanding indications [1]. HDAC inhibitors, a class to which ZOLINZA belongs, have gained prominence as targeted therapies, although their utilization remains constrained by safety profiles and competition.

Currently, the primary treatment options for CTCL include skin-directed therapies (topicals, phototherapy), systemic agents (methotrexate, bexarotene), and other targeted drugs like brentuximab vedotin. ZOLINZA's niche position is bolstered by the lack of first-line HDAC inhibitors, but it faces increasing competition from novel agents and emerging combination therapies.

Market Dynamics

1. Therapeutic Positioning and Uptake

Initially, ZOLINZA experienced moderate adoption, driven by its unique mechanism and FDA approval targeting relapsed CTCL. However, its market penetration has plateaued due to safety concerns, notably thrombocytopenia and fatigue, limiting its use in broader populations. Despite its indications, off-label use remains minimal, partly due to the emergence of alternative therapies with improved safety profiles.

2. Competition and Emerging Therapies

The landscape is increasingly competitive with several agents gaining approval for CTCL and related lymphomas, such as [2]:

• Mogamulizumab: a monoclonal antibody with high specificity for CCR4, approved by FDA in 2018.
• Brentuximab vedotin: an antibody-drug conjugate targeting CD30, licensed for certain T-cell lymphomas.
• Alisertib: an Aurora A kinase inhibitor in development, with potential in lymphoma.

The advent of these targeted approaches has overshadowed HDAC inhibitors like ZOLINZA, impacting its market share.

3. Regulatory and Labeling Developments

While ZOLINZA retains FDA approval for CTCL, ongoing post-marketing surveillance and clinical trials aim to extend its indications or optimize its combination with other agents. The drug's label emphasizes its role in refractory cases, which limits its broader application.

4. Pricing and Reimbursement Trends

The pricing strategy for ZOLINZA remains aligned with targeted oncology therapies, with wholesale acquisition costs approximately USD 10,000–USD 15,000 per month [3]. Reimbursement policies are stringent, with insurance payers critically evaluating its cost-effectiveness given competing therapies.

5. Geographic Expansion and Market Penetration

Geographically, ZOLINZA has achieved moderate penetration in North America and Europe. Regulatory approval in emerging markets depends on local pricing negotiations and healthcare infrastructure capacity. The potential for expansion hinges on local disease prevalence and regulatory pathways.

Financial Trajectory

1. Revenue Trends

Merck's revenue reports indicate that ZOLINZA's annual sales have been relatively stable but modest, generally in the low hundreds of millions USD. For example, Merck's fiscal reports show ZOLINZA generating approx USD 150–200 million annually in recent years [4]. However, growth has stagnated due to competitive pressures and limited indication scope.

2. Revenue Drivers and Limiters

Key factors influencing revenue include:

• Limited patient population (relapsed/refractory CTCL constitutes a small segment).
• Competition from newer agents and combination regimens.
• Pricing pressures amid healthcare cost containment.
• Off-label use constraints.

3. Future Revenue Potential

Projected revenue growth is limited absent expanded indications or combination strategies. Clinical trial data indicating efficacy in other hematologic malignancies (e.g., multiple myeloma, certain solid tumors) could open new markets, but these remain exploratory.

4. Cost of Development and Market Maintenance

Merck will continue to invest in clinical trials aimed at expanding ZOLINZA's indications, with R&D costs offsetting modest revenues. Patent protections, expected to extend until 2026-2027, provide a temporary monopoly, delaying generic competition.

Regulatory Outlook and Market Opportunities

Upcoming clinical trials exploring ZOLINZA's use in combination therapies or novel indications may reshape its market trajectory. Approval of new formulations or semi-synthetic derivatives with improved safety profiles could revive interest. Additionally, strategic collaborations or licensing agreements could broaden access in emerging markets.

Conclusion

ZOLINZA's market dynamics are characterized by a niche but stable position in the highly competitive hematologic oncology sphere. While it remains an essential therapy for refractory CTCL, its growth trajectory is constrained by competitive alternatives, safety concerns, and limited indications. Financially, the drug maintains steady revenue but faces pressures that will challenge its long-term sustainability without expansion into new markets or indications.

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Key Takeaways

• Limited Growth: ZOLINZA's revenue has remained stable but constrained due to its small target patient population and competition.
• Competitive Pressure: Emergence of targeted agents like mogamulizumab and brentuximab vedotin challenges ZOLINZA's market share.
• Potential for Expansion: Clinical trials investigating combination therapies and new indications could expand its financial footprint.
• Pricing and Reimbursement Risks: The high cost and healthcare payers' scrutiny limit broader adoption.
• Patent & Market Lifecycle: Patent expiration around 2026-2027 may invite generic competition, impacting revenues unless new formulations or indications are approved.

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FAQs

1. What is the primary indication for ZOLINZA?
ZOLINZA is approved for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), specifically mycosis fungoides and Sézary syndrome.

2. How does ZOLINZA compare to other HDAC inhibitors?
While ZOLINZA was among the first HDAC inhibitors approved for CTCL, newer agents with improved safety profiles and broader indications are emerging, limiting its competitive edge.

3. Are there ongoing clinical trials for ZOLINZA?
Yes. Trials are exploring its use in combination with other agents, and in emerging indications such as multiple myeloma, though progress is incremental.

4. What are the key barriers to ZOLINZA's market growth?
Safety concerns, a small patient population, increased competition, and high costs hinder growth prospects.

5. What strategic moves could enhance ZOLINZA’s market position?
Potential strategies include obtaining approvals for new indications, developing combination therapies, and expanding into emerging markets with differentiated pricing strategies.

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References

[1] Research and Markets. Oncology Drugs Market Forecast, 2021-2025.
[2] National Cancer Institute. Treatments for Cutaneous T-cell Lymphoma.
[3] Merck & Co. Annual Reports, 2022.
[4] EvaluatePharma. Oncology Drugs Sales Data, 2022.