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ZOLINZA Drug Patent Profile

When do Zolinza patents expire, and what generic alternatives are available?

Zolinza is a drug marketed by Msd Sub Merck and is included in one NDA. There are five 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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	161
Patent Applications:	4,498
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

Constraining patent/regulatory exclusivity:

7,456,219

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
Oregon Health and Science University	Phase 1
OHSU Knight Cancer Institute	Phase 1
Prospect Creek Foundation	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 five US patents.

This potential generic entry date is based on patent 7,456,219.

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	7,851,509		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	7,399,787
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	8,450,372
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006		RX	Yes	Yes	8,093,295		Y

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	RE38506
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	8,101,663
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	7,851,509
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	7,652,069
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	7,732,490

International Patents for ZOLINZA

See the table below for patents covering ZOLINZA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	200727892	Formulations of suberoylanilide hydroxamic acid and methods for producing same
European Patent Office	1663194	Utilisation de SAHA pour traiter le mésotheliome (Use of SAHA for treating mesothelioma)
Russian Federation	2394022	СПОСОБЫ ИНДУКЦИИ КОНЕЧНОЙ ДИФФЕРЕНЦИРОВКИ (METHOD OF INDUCING TERMINAL DIFFERENTIATION)
South Korea	100868813
New Zealand	594669	Oral composition of Vorinostat
Denmark	1663194
Japan	2005525369

ZOLINZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZOLINZA

Introduction to ZOLINZA

ZOLINZA, also known as vorinostat, is a histone deacetylase (HDAC) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least two prior systemic therapies. Here, we delve into the market dynamics and financial trajectory of this significant drug.

Market Segmentation and Target Population

ZOLINZA is part of the broader histone deacetylase inhibitors market, which is segmented by drug, distribution channel, and region. The primary target population for ZOLINZA includes patients with CTCL, particularly those who have failed two or more prior systemic therapies[5].

Clinical Trials and Efficacy

The efficacy of ZOLINZA was evaluated in two single-arm clinical studies involving 107 CTCL patients. In these studies, 86 patients received 400 mg of ZOLINZA once daily, with a median exposure of 97.5 days. The results showed that ZOLINZA can provide significant benefits to CTCL patients, although it is associated with various adverse reactions[3].

Market Drivers

Several factors drive the market growth for ZOLINZA and other HDAC inhibitors:

• Increasing Prevalence of Cancer: The rising incidence of cancer, particularly in regions like North America, is a significant driver. According to the National Institutes of Health (NIH), the high prevalence of cancer cases in the U.S. (439.2 per 100,000 men and women from 2011-2015) indicates a higher adoption rate for HDAC inhibitors[4].

• Research and Development: Ongoing research and clinical trials, such as the study on the combination of exemestane and entinostat for advanced breast cancer, are expected to propel the market growth. Additionally, trials like the one conducted by The Netherlands Cancer Institute on vorinostat for skin neoplasms contribute to the market's expansion[4].

• Regulatory Approvals: Approvals from regulatory bodies, such as the FDA approval for Farydak (another HDAC inhibitor) for multiple myeloma, boost market confidence and growth[4].

Market Restraints

Despite the positive drivers, there are several restraints that affect the market trajectory of ZOLINZA:

• Side Effects: ZOLINZA is associated with severe side effects, including thrombocytopenia, anemia, angioneurotic edema, and other serious adverse reactions. These side effects can hamper market growth as they may deter some patients and healthcare providers from using the drug[3][4].

• Competition: The market for HDAC inhibitors is competitive, with several other drugs available, such as Istodax (romidepsin), Belinostat (Beleodaq), and Panobinostat (Farydak). This competition can impact the market share of ZOLINZA[1][4].

Financial Performance

The financial performance of ZOLINZA is closely tied to its market dynamics:

• Revenue Generation: ZOLINZA contributes to the revenue of its manufacturer, Merck & Co., Inc., although the exact revenue figures for ZOLINZA alone are not always separately disclosed. The drug's sales are part of the broader epigenetic drugs market, which is expected to grow significantly from 2024 to 2031[1].

• Cost and Pricing: The cost of ZOLINZA can be a factor in its adoption. Given its niche use in treating CTCL, the pricing strategy must balance profitability with patient access and affordability.

Key Players and Market Share

Merck & Co., Inc. is a major player in the HDAC inhibitors market, along with other companies like Novartis AG, Celgene Corp., Acrotech Biopharma LLC, and AbbVie Inc. The market share of ZOLINZA within this competitive landscape is influenced by its efficacy, safety profile, and marketing efforts[4].

Regional Analysis

North America is expected to hold a dominant position in the global HDAC inhibitors market, driven by the high prevalence of cancer and advanced healthcare infrastructure. Other regions, such as Europe and Asia Pacific, also contribute significantly to the market growth[4].

Future Outlook

The future outlook for ZOLINZA is promising but complex:

• Ongoing Research: Continued research and development in HDAC inhibitors will likely expand the therapeutic applications of ZOLINZA and similar drugs, potentially increasing market size.

• Regulatory Environment: Favorable regulatory environments and approvals will continue to support market growth.

• Competitive Landscape: The competitive landscape will remain dynamic, with new drugs and therapies emerging, which could impact ZOLINZA's market share.

"Approvals of the drugs related to histone deacetylases from regulatory bodies are expected to boost the global histone deacetylase inhibitors market growth. For instance, in February 2015, Novartis AG received approval for Farydak from U.S. Food & Drug Administration (FDA)"[4].

Key Takeaways

• ZOLINZA is a critical drug in the treatment of CTCL, with a strong market presence driven by its efficacy and regulatory approvals.
• The market is influenced by factors such as the increasing prevalence of cancer, ongoing research, and competitive dynamics.
• Despite its benefits, ZOLINZA faces challenges due to its side effects and competition from other HDAC inhibitors.
• The financial performance of ZOLINZA is integral to the broader epigenetic drugs market, with a promising future outlook tied to ongoing research and favorable regulatory environments.

Frequently Asked Questions (FAQs)

Q1: What is ZOLINZA used for?

ZOLINZA (vorinostat) is used for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least two prior systemic therapies.

Q2: What are the common side effects of ZOLINZA?

Common side effects include thrombocytopenia, anemia, angioneurotic edema, and other serious adverse reactions such as deep vein thrombosis and pulmonary embolism[3].

Q3: Who are the major players in the HDAC inhibitors market?

Major players include Merck & Co., Inc., Novartis AG, Celgene Corp., Acrotech Biopharma LLC, and AbbVie Inc.[4].

Q4: What drives the market growth for ZOLINZA?

Market growth is driven by the increasing prevalence of cancer, ongoing research and development, and favorable regulatory approvals[4].

Q5: What is the regional outlook for the HDAC inhibitors market?

North America is expected to hold a dominant position, followed by Europe and Asia Pacific, due to the high prevalence of cancer and advanced healthcare infrastructure[4].

Sources:

1. iHealthcareAnalyst, Epigenetics Drugs Market and Forecast 2024-2031
2. Merck & Co., Inc., Annual Reports
3. Merck.com, ZOLINZA Prescribing Information
4. Coherent Market Insights, Histone Deacetylase Inhibitors Market
5. Innate Pharma, 20-F MASTER EDGAR Annual Report