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 has been one patent litigation case 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:	114
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

Constraining patent/regulatory exclusivity:

9,186,328

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
Teva Pharmaceutical Industries, Ltd.	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.

This potential generic entry date is based on patent 9,186,328.

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	9,186,328
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No	8,679,544		Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No	9,180,096		Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	9,180,096		Y
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	9,180,095
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-002	Oct 18, 2013		DISCN	Yes	No	9,017,721		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
China	106727477	双氯芬酸的新剂型 (A new formation of diclofenac)
China	104161743	A novel formulation of diclofenac
Japan	2015157851	ジクロフェナクの新規製剤 (NOVEL FORMULATION OF DICLOFENAC)
Malaysia	168079	A NOVEL FORMULATION OF DICLOFENAC
South Korea	20150018647	A NOVEL FORMULATION OF NAPROXEN
World Intellectual Property Organization (WIPO)	2010121327

Market Dynamics and Financial Trajectory for ZORVOLEX

Introduction to ZORVOLEX

ZORVOLEX, a non-steroidal anti-inflammatory drug (NSAID), is specifically formulated to provide pain relief with a lower dose of diclofenac, reducing the risk of gastrointestinal side effects. It is marketed by Horizon Pharma (now part of Amryt Pharma) and is used to treat various pain conditions, including osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Market Size and Growth

The non-opioid pain treatment market, which includes drugs like ZORVOLEX, is experiencing significant growth. The global non-opioid pain treatment market is projected to reach USD 96.25 billion by 2034, growing at a CAGR of 7.12% from 2024 to 2034[1].

Regional Market Dominance

North America, particularly the U.S., dominates the non-opioid pain treatment market, driven by robust medical infrastructure, government initiatives to reduce opioid usage, and the presence of significant pharmaceutical companies. This region is expected to continue its dominance, with the U.S. non-opioid pain treatment market predicted to grow from USD 15.80 billion in 2023 to USD 36.87 billion by 2034 at a CAGR of 8%[1].

Diclofenac Market Overview

Since ZORVOLEX is a formulation of diclofenac, the diclofenac market dynamics are relevant. The global diclofenac market is set to reach $6.1 billion by 2027, growing at a CAGR of 3.9% from 2022 to 2027. North America holds a dominant market share due to its robust medical infrastructure and high health expenditure per person[4].

Key Drivers

• Geriatric Population: The growing number of geriatric populations globally is a significant driver for the diclofenac and non-opioid pain treatment markets. Older adults are more susceptible to inflammation-related problems, fueling the demand for these medications[4].
• Government Initiatives: Government measures to reduce opioid usage and encourage the use of non-opioid pain treatments are crucial drivers. These initiatives include spending and reimbursement policies that support the adoption of non-opioid alternatives[1].
• Advancements in Healthcare: Improvements in healthcare infrastructure and the development of new formulations like ZORVOLEX, which offer lower doses and reduced side effects, are also driving market growth.

Financial Performance

Horizon Pharma, the company behind ZORVOLEX, has seen significant growth in its rheumatology business unit, which includes ZORVOLEX. In 2017, the company's net sales were $1.056 billion, with the rheumatology business unit contributing substantially to this figure. The launch of new medicines and the expansion of the company's pipeline have been key factors in its financial performance[3].

Product-Specific Revenue

While specific financial data for ZORVOLEX is not detailed in the sources, the revenue from Horizon Pharma's promoted products, including those in the rheumatology segment, has shown significant growth. For example, in 2020, revenue related to similar products like Blexten and Cambia increased by 33% compared to the previous year[2].

Market Segmentation

The non-opioid pain treatment market, including diclofenac formulations like ZORVOLEX, is segmented by drug class, pain type, route of administration, distribution channel, and region. The segmentation by indication includes osteoarthritis, ankylosing spondylitis, and rheumatoid arthritis, among others. These segments are crucial for understanding the market's growth potential and targeting specific patient populations[1].

Geographical Growth Opportunities

Asia-Pacific is expected to offer lucrative growth opportunities due to the presence of major drug manufacturers, increasing geriatric population, and favorable government policies such as easy patent regulations and foreign direct investment (FDI) inflows. This region is anticipated to grow at a faster rate compared to other regions[1][4].

Challenges and Opportunities

• Side Effects: Despite the lower dose formulation of ZORVOLEX, NSAIDs can still have side effects, which can hamper market growth. However, the benefits of reduced gastrointestinal risks make it a preferred option for many patients.
• Generic Competition: The launch of generic versions of similar drugs can impact revenue. For instance, the launch of a generic version of Vimovo in 2020 reduced Horizon Pharma's revenue from this product[2].
• Regulatory Environment: The ability to maintain regulatory approvals and navigate changing regulatory landscapes is crucial for the continued success of ZORVOLEX.

Conclusion

The market dynamics for ZORVOLEX are favorable, driven by the growing demand for non-opioid pain treatments, government initiatives, and advancements in healthcare infrastructure. The financial trajectory of Horizon Pharma and the broader diclofenac market indicate strong growth potential, particularly in regions like North America and the Asia-Pacific.

Key Takeaways

• The non-opioid pain treatment market is projected to reach USD 96.25 billion by 2034.
• North America dominates the market, with significant growth expected.
• The diclofenac market, relevant to ZORVOLEX, is set to reach $6.1 billion by 2027.
• Geriatric population growth and government initiatives are key drivers.
• Asia-Pacific offers lucrative growth opportunities due to favorable policies and demographic changes.

FAQs

1. What is the projected market size for non-opioid pain treatments by 2034?

   • The global non-opioid pain treatment market is projected to reach USD 96.25 billion by 2034[1].

2. Which region dominates the non-opioid pain treatment market?

   • North America, particularly the U.S., dominates the non-opioid pain treatment market[1].

3. What is the growth rate of the diclofenac market from 2022 to 2027?

   • The diclofenac market is poised to grow at a CAGR of 3.9% from 2022 to 2027[4].

4. What are the key drivers for the diclofenac and non-opioid pain treatment markets?

   • Key drivers include the growing geriatric population, government initiatives to reduce opioid usage, and advancements in healthcare infrastructure[1][4].

5. Which region is expected to offer the most growth opportunities for the diclofenac market?

   • The Asia-Pacific region is expected to offer lucrative growth opportunities due to favorable government policies and an increasing geriatric population[1][4].

Cited Sources

1. Precedence Research - Non-opioid Pain Treatment Market Size to Hit USD 96.25 by 2034
2. Annual Reports - 2020 Annual Report
3. Annual Reports - 2017 Annual Report
4. IndustryARC - Diclofenac Market Size Report, 2022-2027
5. BioSpace - Zyla Life Sciences Reports Second Quarter 2019 Financial Results