Vorinostat - Generic Drug Details

What are the generic drug sources for vorinostat and what is the scope of freedom to operate?

Vorinostat is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are two drug master file entries for vorinostat. One supplier is listed for this compound.

Summary for vorinostat

International Patents:	131
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	287
What excipients (inactive ingredients) are in vorinostat?	vorinostat excipients list
DailyMed Link:	vorinostat at DailyMed

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

Constraining patent/regulatory exclusivity:

7,456,219

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 vorinostat

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

Sponsor	Phase
New Approaches to Neuroblastoma Therapy Consortium	PHASE2
United Therapeutics	PHASE2
Jubilant DraxImage Inc.	PHASE2

See all vorinostat clinical trials

Pharmacology for vorinostat

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vorinostat

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

US Patents and Regulatory Information for vorinostat

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	8,093,295		Y
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	7,456,219			Y
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	8,450,372

Expired US Patents for vorinostat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	6,087,367
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	8,067,472
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	RE38506
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	7,399,787
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	7,851,509
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	7,732,490

International Patents for vorinostat

Country	Patent Number	Title	Estimated Expiration
Mexico	2007002047	FORMULACIONES DE ACIDO HIDROXAMICO DE SUBEROILANILIDA Y METODOS PARA LA PRODUCCION DE LAS MISMAS. (FORMULATIONS OF SUBEROYLANILIDE HYDROXAMIC ACID AND METHODS FOR PRODUCING SAME.)
Poland	1663194
Hong Kong	1072362	METHODS OF INDUCING TERMINAL DIFFERENTIATION
New Zealand	545935	Method of treating cancer with HDAC inhibitors
Argentina	095159	UNA COMPOSICIÓN FARMACÉUTICA EN FORMA DE CÁPSULA PARA ADMINISTRACIÓN ORAL
South Africa	200601757	Methods of inducing terminal differentiation

Market Dynamics and Financial Trajectory for Vorinostat

Last updated: February 27, 2026

What is Vorinostat?

Vorinostat, marketed as Zolinza, is a histone deacetylase (HDAC) inhibitor approved by the FDA in 2006 for the treatment of cutaneous T-cell lymphoma (CTCL). It has a chemical formula of C14H20N2O3 and a molecular weight of 264.32 g/mol. Originally developed by Merck (MSD outside the U.S.), it is now owned by Sebela Pharmaceuticals following licensing agreements.

Current Market Status

Approved Indications

• Primary: Cutaneous T-cell lymphoma (CTCL)
• Off-label research: Multiple tumor types, including multiple myeloma, glioblastoma, and solid tumors, in clinical trials

Revenue Data

• In 2020, Vorinostat generated approximately $20 million in U.S. sales.
• Global sales remained modest due to limited approved indications and competition from alternative therapies.

Patent Landscape

• Original patents expired around 2016, exposing Vorinostat to generic competition.
• Patent expirations have led to increased price competition and market erosion.

Market Drivers

Unmet Medical Need

• CTCL patients benefit from targeted therapies; limited treatment options exist after first-line failure.
• Vorinostat’s efficacy in a niche market sustains current sales.

Clinical Development and Expansion

• Ongoing trials investigate Vorinostat’s potential in other cancer types and in combination regimes, which could broaden its indications.
• Trials have explored its use in hematological and solid tumors, with some positive preliminary data.

Competitive Landscape

• Other HDAC inhibitors like romidepsin (Istodax) and panobinostat (Farydak) possess similar mechanisms and have broader approval for lymphoma and multiple myeloma.
• Smaller molecule inhibitors and emerging immunotherapies threaten market share.

Pricing and Reimbursement

• The U.S. retail price approximates $6,300 per month.
• Reimbursement remains stable for approved indications but varies internationally.

Market Challenges

Limited Indications

• FDA approval restricted to CTCL limits revenue potential.
• Off-label use lacks robust evidence and faces regulatory hurdles.

Competitive Pressure

• The launch of newer, more potent HDAC inhibitors with better tolerability affects Vorinostat’s position.
• Generic entry sharply reduces prices, impacting profitability.

Developmental and Regulatory Risks

• Clinical trials for new indications have shown mixed results.
• Regulatory rejections or delays could hinder expansion.

Future Financial Trajectory

Aspect	Outlook
Revenue Growth	Expected decline unless new indications or formulations gain approval
Cost of Development	High, with ongoing investments in clinical trials
Market Penetration	Limited, given competition and patent expiration
Licensing Opportunities	Potential for partnerships in rare or underserved cancers

Revenue Projections

• Short-term (1-2 years): Revenue likely to decrease due to patent expiry and generic competition.
• Mid-term (3-5 years): Revenue stabilization possible if new indications are approved and commercialized; ongoing trials may influence this.
• Long-term: Revenue depends heavily on lifecycle management strategies, such as combinatorial therapies or reformulation.

Strategic Considerations

• Product lifecycle extension: Reformulations or novel delivery systems could prolong market relevance.
• Pipeline development: Investing in clinical trials for new indications or combination therapies may rebuild revenue streams.
• Partnership leverage: Collaborations can accelerate expansion into global markets and new indications.

Summary

Vorinostat's market is characterized by a limited indication base, generic competition post-patent expiration, and a crowded HDAC inhibitor landscape. Its future financial trajectory depends on successful expansion into new indications, effective lifecycle management, and competitive positioning against emerging therapies.

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Key Takeaways

• Vorinostat remains a niche drug primarily approved for CTCL.
• Sales are declining post-patent expiry, with revenue heavily impacted by generic competition.
• Market expansion depends on successful clinical trials for new indications.
• Competition from other HDAC inhibitors and targeted therapies restricts growth.
• Strategic initiatives including pipeline development and formulation innovation are critical for longevity.

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FAQs

1. What are the main competitors to Vorinostat?
Romidepsin and panobinostat are HDAC inhibitors with broader indications, forming the primary competitive landscape.

2. Can Vorinostat be used for other cancers?
Clinical trials are ongoing for various tumor types, but no additional indications have received regulatory approval.

3. How does patent expiry affect Vorinostat’s market?
Patent expiry has led to generic entry, reducing prices and sale volumes due to increased competition.

4. What strategies could extend Vorinostat’s market relevance?
Developing new formulations, seeking approval for additional indications, and establishing partnerships could sustain revenues.

5. What are the main risks to its future sales?
Regulatory setbacks, failure to demonstrate benefit in other indications, and aggressive competition pose the biggest threats.

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References

1. U.S. Food and Drug Administration. (2006). FDA approves Zolinza for cutaneous T-cell lymphoma.
2. Sebela Pharmaceuticals. (2022). Vorinostat drug profile.
3. MarketWatch. (2020). Global HDAC inhibitors market analysis.
4. Therapeutic Advances in Hematology. (2018). Clinical trial outcomes of Vorinostat in combination therapies.
5. FDA Label for Zolinza (Vorinostat). (2006).