ZORVOLEX Drug Patent Profile

Which patents cover Zorvolex, and when can generic versions of Zorvolex launch?

Zorvolex is a drug marketed by Zyla and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-three countries.

The generic ingredient in ZORVOLEX is diclofenac. There are forty-seven drug master file entries for this compound. Additional details are available on the diclofenac profile page.

DrugPatentWatch^® Generic Entry Outlook for Zorvolex

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 23, 2030. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (diclofenac), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for ZORVOLEX

International Patents:	44
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	2
Drug Prices:	Drug price information for ZORVOLEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZORVOLEX
What excipients (inactive ingredients) are in ZORVOLEX?	ZORVOLEX excipients list
DailyMed Link:	ZORVOLEX at DailyMed

See drug prices for ZORVOLEX

See drug sales revenues for ZORVOLEX

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

NDA:

204592

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 ZORVOLEX

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 2
Teva Pharmaceutical Industries, Ltd.	Phase 2
Regeneron Pharmaceuticals	Phase 3

See all ZORVOLEX clinical trials

Paragraph IV (Patent) Challenges for ZORVOLEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZORVOLEX	Capsules	diclofenac	18 mg and 35 mg	204592	1	2014-06-06

US Patents and Regulatory Information for ZORVOLEX

ZORVOLEX is protected by seven 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
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No			Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No			Y

International Patents for ZORVOLEX

When does loss-of-exclusivity occur for ZORVOLEX?

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

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Philippines

Singapore

South Africa

South Korea

Tunisia

Ukraine

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 ZORVOLEX around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3290030	FORMULATION DE DICLOFÉNAC (DICLOFENAC FORMULATION)
Philippines	12015500301	A NOVEL FORMULATION OF DICLOFENAC
Mexico	347290	UNA FORMULACION NOVEDOSA DE DICLOFENACO. (A NOVEL FORMULATION OF DICLOFENAC.)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZORVOLEX

Last updated: July 27, 2025

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Introduction

ZORVOLEX, an FDA-approved non-steroidal anti-inflammatory drug (NSAID), has emerged as a distinctive player within the pain management segment. Its unique formulation as a small-dose, sublingual capsule has positioned it as a potentially advantageous alternative to traditional NSAIDs. Analyzing its market dynamics and financial trajectory offers insights into its growth prospects, competitive positioning, and broader industry implications.

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Product Profile and Regulatory Milestones

ZORVOLEX (diclofenac) is marketed by SIGA Technologies, primarily for mild to moderate acute pain and osteoarthritis-related pain. Its sublingual, orally disintegrating capsule formulation facilitates rapid absorption, addressing patient needs for prompt relief without gastrointestinal discomfort common with other NSAIDs [1]. Regulatory approvals, achieved in 2017, marked the company's strategic entry into the NSAID market, a lucrative segment with well-established competitors like ibuprofen and naproxen.

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Market Landscape and Demand Drivers

Growing Pain Management Market

The global pain management market is projected to reach USD 82 billion by 2025, growing at a compound annual growth rate (CAGR) of approximately 4.7% [2]. The rise is driven by increasing prevalence of chronic diseases such as osteoarthritis, rheumatoid arthritis, and acute pain conditions, especially among aging populations. The demand for effective, fast-acting NSAIDs like ZORVOLEX is expected to benefit from this trend.

Shifting Prescribing Patterns and Patient Preferences

Physicians increasingly favor medications that optimize efficacy while minimizing adverse effects. ZORVOLEX's formulation promises improved gastrointestinal tolerability, which is crucial given the widespread concerns over NSAID-induced gastric ulcers. Patient preferences for convenience and rapid relief further bolster demand for formulations like ZORVOLEX's sublingual capsules.

Competitive Dynamics

The NSAID market is highly competitive, with established drugs like ibuprofen, naproxen, and diclofenac available as generics. ZORVOLEX's niche positioning hinges on its formulation and safety profile, but market penetration faces challenges due to pricing, brand recognition, and physician familiarity with generic alternatives [3].

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Market Penetration Strategies and Challenges

Pricing and Reimbursement

ZORVOLEX's pricing strategy plays a critical role in its financial trajectory. Positioned as a branded specialty drug, its price point is higher than generics, affecting adoption amongst cost-sensitive providers and payers. Securing favorable reimbursement pathways remains essential for expanding access and sales volumes.

Physician Education and Brand Differentiation

Effective educational campaigns emphasizing ZORVOLEX’s benefits—rapid onset, reduced gastrointestinal risk—are vital for influencing prescribing behaviors. However, the need to justify premium pricing could limit broad market penetration in favor of niche indications.

Patent and Patent Litigation Outlook

Although SIGA holds certain patent protections, generic manufacturers have challenged and entered the market for diclofenac products elsewhere, illustrating the importance of maintaining robust IP portfolios and anticipating patent challenges.

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Financial Trajectory and Growth Projections

Sales Performance and Revenue Trends

Since its launch, ZORVOLEX has demonstrated modest sales, reflecting cautious penetration. In fiscal year 2021, SIGA reported that ZORVOLEX generated approximately USD 10 million, with potential growth driven by increased prescribing and expanded indications [4]. The drug's financial trajectory is contingent upon expanding indications, increasing awareness, and reimbursability.

Market Expansion Opportunities

Potential growth avenues include:

• Chronic Pain Management: Expanding beyond acute pain to chronic osteoarthritis or rheumatoid arthritis.
• Geographic Expansion: Entering international markets where NSAID prescribing is prevalent.
• Combination Therapies: Developing formulations that combine diclofenac with other analgesics or gastrointestinal protectants.

Risks and Limitations

• Market Competition: The dominance of low-cost generics limits pricing power.
• Regulatory and Patent Risks: Patent expirations and regulatory hurdles could impair revenue streams.
• Market Acceptance: Slow adoption due to clinician unfamiliarity or entrenched prescribing habits.

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Industry Trends Impacting ZORVOLEX’s Future

Generic Drug Market Dynamics

The NSAID segment is heavily commoditized. Price erosion due to generics pressures innovation-driven brands like ZORVOLEX to innovate or differentiate further.

Shift Toward Personalized Medicine

Increasing focus on tailored therapies may influence ZORVOLEX’s positioning, especially if pharmacogenomics identifies patient populations that benefit from its specific formulation.

Digital and Direct-to-Consumer Marketing

Emerging digital marketing strategies could enhance brand awareness, but regulatory limitations around direct promotion for prescription drugs remain a challenge.

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Conclusion: Strategic Outlook

ZORVOLEX's financial trajectory hinges on careful balancing of innovation, pricing strategies, and market expansion. While its niche positioning offers growth opportunities within specialized pain management, industry-wide pressures from generics and pricing scrutiny present ongoing challenges. To capitalize on its potential, SIGA must underscore ZORVOLEX's unique benefits, effectively navigate reimbursement pathways, and explore broader indications and markets.

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Key Takeaways

• ZORVOLEX occupies a niche market segment focused on rapid, gastrointestinal-friendly pain relief, offering a differentiated profile among NSAIDs.
• The overall pain management market's growth benefits ZORVOLEX, but intense competition from generics constrains pricing and market share expansion.
• Strategies emphasizing physician education, favorable reimbursement policies, and international expansion are crucial for improving sales trajectory.
• Patent protections and early adoption drive revenue stability; patent cliffs or legal challenges could significantly impact future earnings.
• Industry trends toward personalized medicine and digital outreach present both opportunities and barriers for ZORVOLEX’s sustained growth.

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FAQs

1. How does ZORVOLEX differ from traditional NSAIDs?
ZORVOLEX’s formulation as an oral disintegrating capsule allows for rapid absorption and onset of pain relief, with an improved gastrointestinal safety profile compared to traditional NSAIDs taken as tablets or capsules.

2. What are the main market challenges facing ZORVOLEX?
The primary challenges include stiff competition from low-cost generics, pricing pressure, limited international presence, patent expiration risks, and slow adoption driven by clinician familiarity with established NSAIDs.

3. Are there expanded indications for ZORVOLEX?
Currently approved for acute pain and osteoarthritis, future expansion may depend on clinical trials demonstrating efficacy in other inflammatory or chronic pain conditions.

4. How significant are reimbursement pathways for ZORVOLEX’s financial success?
Reimbursement is critical; favorable coverage influences prescribing habits and patient access, directly impacting sales growth.

5. What strategic moves could enhance ZORVOLEX’s market share?
Developing new formulations or combination therapies, expanding into international markets, investing in physician education, and securing broader patents are potential avenues for growth.

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References

[1] FDA Product Label for ZORVOLEX, 2017.
[2] MarketsandMarkets, Pain Management Market Report, 2022.
[3] IQVIA, US Prescription Data, 2022.
[4] SIGA Technologies Annual Report, 2021.