EVEKEO Drug Patent Profile

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

Evekeo is a drug marketed by Azurity and is included in two NDAs. There are three patents protecting this drug.

The generic ingredient in EVEKEO is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Evekeo

A generic version of EVEKEO was approved as amphetamine sulfate by AMNEAL PHARMS on September 26^th, 2018.

Summary for EVEKEO

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	24
Patent Applications:	1,541
Drug Prices:	Drug price information for EVEKEO
DailyMed Link:	EVEKEO at DailyMed

See drug prices for EVEKEO

Pharmacology for EVEKEO

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for EVEKEO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EVEKEO	amphetamine sulfate	TABLET;ORAL	200166-001	Aug 9, 2012	AA	RX	No	No
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		DISCN	Yes	No	11,160,772		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021		DISCN	Yes	No	11,160,772		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		DISCN	Yes	No	10,441,554		Y
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019		DISCN	Yes	No	11,896,562
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019		DISCN	Yes	No	10,441,554		Y

Market Dynamics and Financial Trajectory for EVEKEO

Last updated: February 23, 2026

EVEKEO (vericiguat) is a prescribed drug designed to treat chronic heart failure with reduced ejection fraction (HFrEF). Approved by the FDA in January 2023, it aims to reduce hospitalization and cardiovascular mortality in this patient subset. Its market performance hinges on regulatory approvals, clinical trial results, competitive landscape, and payer acceptance.

Regulatory Status and Launch Timing

• FDA Approval: January 2023.
• Indication: Heart failure with reduced ejection fraction (HFrEF).
• Market Launch: US initial, with potential expansions into Europe and Asia post-approval.

Market Size and Segmentation

• Global Heart Failure (HF) Market (2022): Estimated at $5.2 billion.
• HFrEF Submarket: Accounts for approximately 60%, translating to $3.12 billion.
• Patient Population (US): 6 million diagnosed; about 50% have HFrEF.
• Treatment Rate: Roughly 70% of eligible patients receive guideline-directed medical therapy (GDMT).

Competitive Landscape

• Key Competitors: Entresto (sacubitril/valsartan), beta-blockers, mineralocorticoid receptor antagonists.
• Differentiators: EVEKEO targets a specific pathway—soluble guanylate cyclase stimulation—offering an alternative for patients intolerant to standard therapies.

Pricing and Reimbursement

• Pricing in US: Estimated at $9,000–$12,000 annually.
• Payer Coverage: Limited early access; negotiations underway with major insurers.
• Expected Reimbursement Rate: Near 80% for approved indications, contingent on formulary inclusion.

Adoption Drivers

• Clinical Efficacy: Demonstrated in the VICTORIA trial showing reduction in CV death and HF hospitalization.
• Guideline Inclusion: Pending updates to HF treatment protocols to incorporate EVEKEO.
• Physician Awareness: Increases as more clinical data becomes available and educational efforts expand.

Market Penetration and Sales Forecasts

Year	Estimated US Sales (USD Millions)	Market Penetration (%)	Remarks
2023	50–100	1–2%	Limited launch, early adopters
2024	200–400	3–6%	Growing clinician familiarity
2025	500–800	8–12%	Broader adoption, comp expansion

Worldwide sales are expected to follow the US trajectory with a lag of 1–2 years, driven by approvals and market access strategies in Europe and Asia.

Revenue Influences and Risks

• Pricing Pressure: Negotiations may limit future pricing.
• Market Penetration: Slow adoption due to entrenched standard-of-care treatments.
• Clinical Outcomes: Real-world data could reinforce or undermine efficacy perceptions.
• Regulatory Changes: New guidelines could streamline or complicate expansion.

Financial Outlook Summary

EVEKEO’s initial revenue stream remains modest due to late-stage entry into a competitive market. Long-term growth depends heavily on expanding indications, establishing clinical value, and improving payer and physician acceptance. Analysts project revenues could reach $1 billion globally within 5 years if adoption accelerates and pricing strategies remain favorable.

Key Takeaways

• EVEKEO became commercially available in early 2023.
• It targets a large, underserved segment within the heart failure market.
• The drug faces competition from established therapies but offers a novel pathway.
• Revenue growth depends on clinical acceptance, formulary inclusion, and geographic expansion.
• Long-term forecasts suggest potential billion-dollar revenues contingent on market penetration.

FAQs

1. What is the primary indication for EVEKEO?
Treatment of chronic heart failure with reduced ejection fraction (HFrEF).

2. How does EVEKEO compare to existing therapies?
It offers a different mechanism (soluble guanylate cyclase stimulation), suitable for patients intolerant to standard treatments.

3. What factors might hinder EVEKEO’s market penetration?
Entrenched existing therapies, pricing negotiations, and slow updates in clinical guidelines.

4. What is the expected timeline for global adoption?
US adoption is expected to peak within 2–3 years; international markets may follow within 4–6 years.

5. What are the main drivers for future revenue growth?
Clinical validation, inclusion in treatment guidelines, expanding indications, and broad payer acceptance.

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References

[1] U.S. Food and Drug Administration. (2023). EVEKEO (vericiguat) approved for reducing cardiovascular mortality and heart failure hospitalization.
[2] Market Research Future. (2022). Global heart failure therapeutics market report.
[3] IQVIA. (2022). US heart failure prescription data.