EPANOVA Drug Patent Profile

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

Epanova is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.

This drug has eighty-five patent family members in forty-one countries.

The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this compound. Additional details are available on the omega-3-carboxylic acids profile page.

DrugPatentWatch^® Generic Entry Outlook for Epanova

Epanova was eligible for patent challenges on May 5, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EPANOVA

International Patents:	85
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	129
DailyMed Link:	EPANOVA at DailyMed

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

NDA:

205060

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 EPANOVA

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

Sponsor	Phase
Quintiles, Inc.	Phase 3
IQVIA RDS Inc.	Phase 3
The Cleveland Clinic	Phase 3

See all EPANOVA clinical trials

US Patents and Regulatory Information for EPANOVA

EPANOVA 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
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No				Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No

Expired US Patents for EPANOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014

International Patents for EPANOVA

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

Country	Patent Number	Title	Estimated Expiration
China	1104237
Croatia	P20181418
New Zealand	626699
Russian Federation	2018116572
Singapore	10201701004R
Slovakia	152397	TREATMENT OF INFLAMMATORY BOWEL DISEASE USING ORAL DOSAGE FORMS OF OMEGA-3 POLYUNSATURATED ACIDS
World Intellectual Property Organization (WIPO)	2016175868

Market Dynamics and Financial Trajectory for Epanova

Introduction

Epanova, an omega-3 carboxylic acid prescription drug, has been a significant player in the market for managing high triglyceride levels and other cardiovascular conditions. However, its market dynamics and financial trajectory have been influenced by several key factors, including clinical trial outcomes, market competition, and regulatory approvals.

Clinical Trial Outcomes

One of the most critical events impacting Epanova's market dynamics was the conclusion of the Phase III STRENGTH trial. This large-scale cardiovascular outcomes trial was designed to evaluate the safety and efficacy of Epanova in patients with mixed dyslipidaemia (MDL) who are at increased risk of cardiovascular disease. However, the trial was discontinued due to the low likelihood of demonstrating a benefit to patients, as recommended by an independent Data Monitoring Committee[4][5].

Impact on Market Perception

The discontinuation of the STRENGTH trial had a significant negative impact on the market perception of Epanova. This outcome raised doubts about the drug's efficacy in reducing cardiovascular risks, which is a critical aspect of its intended use. As a result, physicians and patients may have become less confident in prescribing and using Epanova, respectively.

Financial Implications

The failure of the STRENGTH trial led to substantial financial implications for AstraZeneca, the manufacturer of Epanova. A review of the ongoing value of the $533 million Epanova intangible asset was undertaken, and an impairment charge of up to $533 million was recorded. Additionally, a write-down of up to $100 million relating to inventories was anticipated, impacting the core earnings in the fourth quarter of 2019[2][5].

Market Size and Growth

Despite the challenges faced by Epanova, the overall omega-3 prescription drugs market continues to grow. The global market size for omega-3 prescription drugs was estimated to be around $1.34 billion in 2023 and is projected to reach $2.93 billion by 2034, growing at a CAGR of 7.37% from 2024 to 2034. However, Epanova's share within this market is likely to be affected by the negative outcomes of the STRENGTH trial[1].

Competitive Landscape

Epanova competes in a market dominated by other omega-3 prescription drugs such as Vascepa and Lovaza. Vascepa, in particular, has seen significant adoption due to its FDA approval and robust clinical evidence demonstrating its effectiveness in reducing high triglyceride levels. The growth of the "others" segment, which includes Lovaza, is also driven by the widespread availability of generic alternatives and increasing adoption among the target demographic[1].

Distribution and Accessibility

The distribution channels for Epanova, like other omega-3 prescription drugs, include hospital pharmacies, retail pharmacies, and online pharmacies. However, the accessibility and recommendation of Epanova by physicians may have been impacted by the negative trial results, potentially reducing its market share in these channels[1].

Consumer Awareness and Preferences

Increasing awareness of the health benefits of omega-3 fatty acids continues to drive the market. However, consumers and healthcare providers are becoming more discerning, favoring products with strong clinical evidence. The failure of the STRENGTH trial may have shifted preferences away from Epanova towards other proven alternatives[1][3].

Innovative Formulations and Personalized Medicine

The omega-3 prescription drugs market is evolving with the introduction of innovative formulations and the adoption of personalized medicine. While Epanova may not have benefited from these trends due to its trial outcomes, other drugs in the market are likely to see increased adoption as they offer targeted health solutions and broader scopes of indications[3].

Financial Performance of AstraZeneca

AstraZeneca's financial performance has been resilient despite the challenges faced by Epanova. The company has diversified revenue streams from various products and geographic regions, which helps mitigate the impact of any single product's performance. However, the impairment charges and inventory write-downs related to Epanova have had a noticeable effect on the company's financial statements[2].

Key Takeaways

• The discontinuation of the STRENGTH trial significantly impacted Epanova's market dynamics and financial trajectory.
• The omega-3 prescription drugs market continues to grow, but Epanova's share is likely reduced due to negative trial outcomes.
• Competitive drugs like Vascepa and Lovaza have stronger market positions due to robust clinical evidence.
• Consumer awareness and preferences are shifting towards products with proven efficacy.
• AstraZeneca's financial performance remains resilient despite the challenges faced by Epanova.

FAQs

Q: What was the outcome of the Phase III STRENGTH trial for Epanova? A: The Phase III STRENGTH trial for Epanova was discontinued due to the low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia.

Q: How did the STRENGTH trial outcome impact AstraZeneca financially? A: The trial outcome led to an impairment charge of up to $533 million and a write-down of up to $100 million relating to inventories.

Q: What is the projected growth of the omega-3 prescription drugs market? A: The global omega-3 prescription drugs market is expected to grow from $1.34 billion in 2023 to $2.93 billion by 2034, at a CAGR of 7.37%.

Q: Which drug dominates the omega-3 prescription drugs market? A: Vascepa dominates the global omega-3 prescription drugs market due to its wide adoption and robust clinical evidence.

Q: How has consumer awareness impacted the market for omega-3 prescription drugs? A: Increasing awareness of the health benefits of omega-3 fatty acids drives the market, but consumers are favoring products with strong clinical evidence, potentially reducing demand for Epanova.

Cited Sources:

1. Precedence Research - Omega 3 Prescription Drugs Market - Size, Companies & Trends
2. AstraZeneca - Financial Statements PDF 2254KB - AstraZeneca Annual Report and Form 20-F Information 2020
3. Research and Markets - Omega 3 Prescription Drugs Global Market Size & Competitors
4. AstraZeneca - Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia
5. Cardiometabolic Health Congress - Conclusion of Phase III STRENGTH trial for Epanova - CMHC