LOVAZA Drug Patent Profile

When do Lovaza patents expire, and when can generic versions of Lovaza launch?

Lovaza is a drug marketed by Woodward and is included in one NDA.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lovaza

A generic version of LOVAZA was approved as omega-3-acid ethyl esters by GLW on April 7^th, 2014.

Summary for LOVAZA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	82
Patent Applications:	222
Drug Prices:	Drug price information for LOVAZA
Drug Sales Revenues:	Drug sales revenues for LOVAZA
What excipients (inactive ingredients) are in LOVAZA?	LOVAZA excipients list
DailyMed Link:	LOVAZA at DailyMed

See drug prices for LOVAZA

See drug sales revenues for LOVAZA

Recent Clinical Trials for LOVAZA

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

Sponsor	Phase
Prisma Health-Midlands	Phase 2/Phase 3
H. Lee Moffitt Cancer Center and Research Institute	Phase 2
James and Esther King Biomedical Research Program	Phase 2

See all LOVAZA clinical trials

Paragraph IV (Patent) Challenges for LOVAZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOVAZA	Capsules	omega-3-acid ethyl esters	1 g	021654	3	2008-11-10

US Patents and Regulatory Information for LOVAZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	AB	RX	Yes	Yes

Expired US Patents for LOVAZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004

International Patents for LOVAZA

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

Country	Patent Number	Title	Estimated Expiration
Argentina	079872	UN PROCESO PARA DISMINUIR LA CANTIDAD DE CONTAMINANTES MEDIOAMBIENTALES PRESENTES EN UNA MEZCLA
France	2635263
Cyprus	1109971
Argentina	098306	UN PROCESO PARA DISMINUIR LA CANTIDAD DE CONTAMINANTES MEDIOAMBIENTALES SELECCIONADOS DE RETARDANTES DE LLAMA BROMADOS EN UNA MEZCLA QUE COMPRENDE UNA GRASA O UN ACEITE, QUE SON COMESTIBLES O PARA SU USO EN COSMÉTICA, CONTENIENDO LA GRASA O EL ACEITE LOS CONTAMINANTES MEDIOAMBIENTALES
Finland	893805
Slovenia	1523541
Australia	616784

LOVAZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lovaza

Market Overview

The omega-3 prescription drugs market, which includes Lovaza, is poised for significant growth driven by several key factors. Here are the dynamics and financial trajectories that shape the market for Lovaza.

Market Growth Drivers

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of cardiovascular diseases such as hyperlipidemia and atherosclerosis is a major driver for the omega-3 prescription drugs market. Lovaza, in particular, benefits from this trend as it is widely recognized for its efficacy in reducing triglyceride levels and improving lipid profiles, which are crucial for heart health[1][4].

Expanding Adoption of Omega-3 Therapies

There is an increasing awareness and adoption of omega-3 therapies for managing various health conditions. Lovaza, being a well-established player, is expected to experience moderate growth opportunities during the forecast period due to its proven efficacy in managing hypertriglyceridemia[1][4].

Cost-Effectiveness of Generic Alternatives

Lovaza, although a branded drug, faces competition from generic omega-3 products. However, its cost-effectiveness compared to other branded options and the availability of generic alternatives of Lovaza itself contribute to its market presence. Generic products offer similar therapeutic benefits at a lower cost, making them a preferred choice for patients and healthcare providers[1].

Market Segmentation

By Application

The cardiovascular segment dominates the market, accounting for 86.8% of the revenue share in 2024. Lovaza is primarily prescribed for managing hypertriglyceridemia and other cardiovascular conditions, making it a key player in this segment[1][4].

By Distribution Channel

Retail pharmacies account for the largest revenue share of 53.6% in 2024, due to their wide accessibility and consumer convenience. The online pharmacy segment is also expected to witness moderate growth, driven by increasing consumer preference for convenient healthcare solutions[4].

Financial Performance

Historical Sales

In the past, Lovaza has experienced fluctuations in sales. For example, in 2015, sales of Lovaza in the US fell by 64% to £93 million, reflecting broader market dynamics and competition[5].

Current Financial Trajectory

Despite historical fluctuations, Lovaza is projected to experience moderate growth. The acquisition of Lovaza by Woodward Pharma Services LLC from GlaxoSmithKline in August 2021 is expected to boost its market presence through increased consumer and provider education[4].

Revenue Projections

The global omega-3 prescription drugs market, which includes Lovaza, is expected to reach USD 1.80 billion by 2030, growing at a CAGR of 4.90%. This growth is largely driven by the significant role of omega-3 fatty acids in managing cardiovascular diseases[4].

Challenges and Opportunities

Pricing Pressures and Regulatory Considerations

Lovaza faces pricing pressures and regulatory challenges that can impact its market dynamics. However, its established market presence and proven efficacy help it maintain a steady growth trajectory[1].

Research and Development

Ongoing R&D studies, such as the analysis of 17 randomized clinical trials, highlight the efficacy of prescription omega-3 fatty acid medications in reducing triglyceride levels by 20-30%. This research supports the continued adoption of Lovaza and other omega-3 prescription drugs[4].

Regional Market Dynamics

Latin America

The Latin American market, particularly Brazil, is witnessing steady growth driven by an increasing focus on healthcare accessibility and a rising prevalence of cardiovascular conditions. Government policies to improve healthcare coverage and expand access to prescription drugs support the market expansion for Lovaza[1].

Key Takeaways

• Growing Demand for Cardiovascular Management: The increasing prevalence of cardiovascular diseases drives the demand for Lovaza.
• Cost-Effectiveness: Generic alternatives and the cost-effectiveness of Lovaza contribute to its market presence.
• Moderate Growth: Lovaza is projected to experience moderate growth opportunities despite competition and pricing pressures.
• Regulatory and R&D Impact: Ongoing research and regulatory considerations influence the market dynamics for Lovaza.
• Regional Growth: Latin America, especially Brazil, presents significant growth opportunities due to healthcare accessibility and rising cardiovascular conditions.

FAQs

What are the primary drivers for the growth of the Lovaza market?

The primary drivers include the rising prevalence of cardiovascular diseases, increased awareness of lipid management, and the expanding adoption of omega-3 therapies.

How does the availability of generic alternatives impact Lovaza's market presence?

The availability of generic alternatives makes Lovaza more competitive in terms of cost, as these generics offer similar therapeutic benefits at a lower cost, making them a preferred choice for patients and healthcare providers.

What is the projected growth rate for the global omega-3 prescription drugs market?

The global omega-3 prescription drugs market is expected to grow at a CAGR of 4.90% and reach USD 1.80 billion by 2030.

Which segment dominates the omega-3 prescription drugs market?

The cardiovascular segment dominates the market, accounting for 86.8% of the revenue share in 2024.

How does the online pharmacy segment impact the market for Lovaza?

The online pharmacy segment is expected to witness moderate growth due to increasing consumer preference for convenient and accessible healthcare solutions.

Sources

1. Grand View Research: Omega 3 Prescription Drugs Market | Industry Report, 2030
2. Amarin Corporation: Amarin Reports Third Quarter 2018 Financial Results and Provides Business Update
3. Market Publishers: Omega 3 Prescription Drugs Market Size, Trends, Analysis, and Outlook By Drug (Vascepa, Lovaza, Others), By Application (Hypertriglyceridemia, Others), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy), by Region, Country, Segment, and Companies, 2024-2030
4. Grand View Research: Omega 3 Prescription Drugs Market To Reach $1.80Bn By 2030
5. GlaxoSmithKline: Press release - Full year and fourth quarter 2015 - GSK