etripamil - Profile

What are the generic sources for etripamil and what is the scope of freedom to operate?

Etripamil is the generic ingredient in one branded drug marketed by Milestone Pharms Usa and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etripamil has sixty-six patent family members in twenty-nine countries.

Summary for etripamil

International Patents:	66
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for etripamil

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

SPRAY;NASAL

^*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.

US Patents and Regulatory Information for etripamil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes			Y
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes
Milestone Pharms Usa	CARDAMYST	etripamil	SPRAY;NASAL	218571-001	Dec 12, 2025		RX	Yes	Yes

International Patents for etripamil

Country	Patent Number	Title	Estimated Expiration
Australia	2008266798
Brazil	PI0812919
Canada	2693627
China	101754678	Short acting phenylalkylamine calcium channel blockers and uses thereof

Investment Scenario and Fundamentals Analysis for Etripamil

Last updated: February 19, 2026

Etripamil is an investigational nasal calcium channel blocker developed for the acute treatment of supraventricular tachycardia (SVT). Its potential as an on-demand therapy for arrhythmias positions it as a candidate for niche clinical markets. This report evaluates its current development status, clinical data, competitive landscape, regulatory pathway, and investment prospects.

Drug Overview

Attribute	Details
Generic Name	Etripamil
Drug Class	Calcium channel blocker
Formulation	Nasal spray
Indication	Paroxysmal supraventricular tachycardia (PSVT)
Developer	Neurelis, Inc.
Mechanism	Blocks L-type calcium channels in cardiac tissue

Development Status

Etripamil has completed Phase 2 clinical trials with several key milestones achieved:

• Phase 2b Trial (NCT03009381): Demonstrated reduction in symptom duration and SVT episodes following nasal administration.
• Regulatory filings: The company submitted an Investigational New Drug (IND) application and sought FDA guidance, with a focus on expedited pathways.
• Current phase: Plans for Phase 3 trials are underway, with potential for accelerated approval based on breakthrough device designation received from the FDA.

Clinical Data and Efficacy

Key Trial Results

• Effectiveness: In Phase 2b, approximately 75% of patients experienced termination of SVT within five minutes of nasal delivery.
• Safety profile: No serious adverse events reported; mild nasal discomfort and transient hypotension observed.
• Durability: Etripamil acts rapidly but has brief duration, necessitating repeat dosing for recurrent episodes.

Limitations of Data

• Sample size: Small, with around 100 participants.
• Long-term safety: Not established beyond initial trials.
• Comparative efficacy: Lacks head-to-head data with existing therapies like adenosine or verapamil.

Competitive Landscape

Competitor	Drug/Formulation	Marketed / Investigational	Key Attributes
Adenosine	Intravenous	Marketed	Rapid termination, invasive administration
Valsalva maneuver	Non-pharmacologic, patient-managed	Non-drug approach	Low cost, variable efficacy
Verapamil	Oral/intravenous	Marketed	Used off-label for SVT, slower onset
Novel nasal therapies	Emerging investigational drugs	Early phase investigations	Aim for non-invasive, rapid action

Etripamil’s nasal route offers a desirable alternative to injections and IV administration, but competition from existing oral and IV agents remains strong.

Regulatory Pathway and Market Entry

• Breakthrough device designation: Facilitates expedited review process.
• Orphan drug status: Not currently pursued, limiting market exclusivity.
• Market size: Estimated at 300,000 annual SVT episodes in the US, with repeat episodes in diagnosed patients.

Challenges

• Demonstrating superior safety and efficacy over standard treatments.
• Managing rapid, predictable dosing due to brief duration.
• Securing reimbursement from payers without a clearly differentiated benefit profile.

Investment Prospects and Risks

Upside Factors

• Early positive Phase 2 data suggest potential efficacy.
• Non-invasive nasal administration could improve patient adherence.
• Regulatory milestones may catalyze valuation increases.

Risks

• Clinical efficacy primarily demonstrated in small trials.
• Potential safety issues emerging in larger populations.
• Competitive therapies could improve, reducing market share.
• Reimbursement hurdles if marginal benefits are not demonstrated.

Financial Considerations

• Funding stage: Pre-Commercial; potential for partnership or licensing.
• Market potential: Limited by the niche indication but attractive due to unmet need.
• Valuation drivers: Regulatory milestones, clinical trial outcomes, competitive landscape.

Key Takeaways

Etripamil's potential hinges on successful Phase 3 trials and regulatory approval driven by its non-invasive nasal delivery. While initial efficacy signals are promising, limited data and competition pose risks. The targeted SVT market size remains modest, but unmet need supports niche adoption. Significant value hinges on clinical success and regulatory navigation within a competitive environment.

FAQs

1. What makes Etripamil different from existing SVT treatments?
   It offers rapid, non-invasive nasal delivery compared to IV or oral therapies.

2. When are Phase 3 trials expected to start?
   As of the latest updates, plans are underway, with potential initiation in 2023 or early 2024.

3. What regulatory designations does Etripamil have?
   It has received FDA breakthrough device designation, facilitating faster review.

4. What are the primary risks for investors?
   Clinical efficacy and safety concerns in larger populations, and competitive market developments.

5. What is the estimated market size for Etripamil?
   Roughly 300,000 SVT episodes annually in the US, with a smaller repeat patient subset.

References

1. Neurelis, Inc. (2022). Etripamil clinical development program.
2. U.S. Food and Drug Administration. (2022). Breakthrough devices program.
3. MarketResearch.com. (2023). SVT market overview and epidemiology.