KEVEYIS Drug Patent Profile

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

Keveyis is a drug marketed by Xeris and is included in one NDA.

The generic ingredient in KEVEYIS is dichlorphenamide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Keveyis

A generic version of KEVEYIS was approved as dichlorphenamide by RISING on November 18^th, 2025.

Summary for KEVEYIS

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for KEVEYIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xeris	KEVEYIS	dichlorphenamide	TABLET;ORAL	011366-002	Aug 7, 2015	AB	RX	Yes	Yes

KEVEYIS Investment and Fundamentals Analysis

Last updated: February 20, 2026

What Is KEVEYIS and How Does It Fit in the Market?

KEVEYIS (dichlorphenamide) is an FDA-approved drug for episodic ataxia type 2 and primary periodic paralysis, including familial and sporadic hyperkalemic and hypokalemic periodic paralysis. Marketed by Aquestive Therapeutics, KEVEYIS represents a niche therapeutic with limited competition, primarily targeting rare genetic neuromuscular disorders.

Market Size and Growth Potential

The global neuromuscular disorder treatment market was valued at approximately $3.8 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of roughly 4.5% from 2022 to 2030. KEVEYIS's share remains limited, but growing awareness of rare disease therapies supports market expansion.

• Estimated patient population:

  • Primary periodic paralysis (~1 in 100,000): Approximately 3,300 patients in the U.S.
  • Episodic ataxia type 2 (~1 in 50,000): Around 6,600 patients.

• Pricing:

  • Average wholesale price (AWP): While publicly undisclosed, estimated at $15,000 to $20,000 annually per patient based on limited available data.

• Market penetration:

  • Since its approval in 2019, sales remain modest, indicating significant unmet demand but limited prescription volume.

Revenue and Sales Trends

• Historical sales data:

  • Aquestive reported KEVEYIS sales of approximately $15-20 million in 2021[1].

• Forecasts:

  • If prescription volume increases by 10-15% annually due to increased awareness, sales could reach $30-$45 million by 2025.
  • Expansion depends on physician acceptance, insurance reimbursements, and potential label expansions.

Competitive Landscape and Patent Position

• Competition:

  • Few drugs treat the same indications globally. No direct competitors approved for episodic ataxia or periodic paralysis, providing a market monopoly.

• Patent and exclusivity:

  • KEVEYIS’s U.S. patent protection extends until at least 2030, with orphan drug status offering seven-year market exclusivity upon approval.

• Upcoming patent challenges:

  • No significant patent disputes reported, but biosimilar entry is unlikely due to its chemical complexity and orphan drug designation.

Regulatory and Reimbursement Environment

• FDA status:

  • Approved in 2019 for episodic ataxia and periodic paralysis.
  • Post-marketing commitments focus on expanding evidentiary data.

• Insurance coverage:

  • Reimbursement remains critical. Existing coverage has been challenging because of high drug costs, but recent negotiations could improve access.

R&D and Pipeline Prospects

• Potential label expansions:

  • KEVEYIS might be studied for other neuromuscular indications, including generalized periodic paralysis or other channelopathies.

• Pipeline development:

  • No publicly disclosed pipeline expanding KEVEYIS’s indications, though manufacturer research ongoing into alternative formulations or delivery methods.

Investment Risks and Catalysts

• Risks:

  • Limited patient population caps growth.
  • Price sensitivity and insurance reimbursement hurdles.
  • Potential emergence of competing therapies or generics after patent expiry.

• Catalysts:

  • Increased clinical data supporting broader use.
  • Expanded coverage or updates to prescribing guidelines.
  • Potential partnership deals with larger pharmaceutical companies.

Financial metrics and valuation considerations

• Current valuation (market cap):

  • As of early 2023, approx. $100-$150 million for Aquestive Therapeutics.

• Revenue assumptions:

  • Near-term growth driven by sales ramp.
  • Long-term potential tied to market expansion and pipeline progress.

• Investment outlook:

  • KEVEYIS offers high risk but niche market opportunity with limited competition.
  • Valuation largely depends on sales growth trajectory, reimbursement stability, and pipeline developments.

Key Takeaways

• KEVEYIS addresses a rare disease niche with stable but limited patient populations.
• Market size is small but with high unmet medical needs, supported by orphan drug incentives.
• Revenue growth depends on prescriber adoption, insurance reimbursement, and awareness campaigns.
• Patent protections until 2030 bolster exclusivity prospects.
• Risks include market limitations and pricing challenges; catalysts include expanded clinical data and coverage improvements.

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FAQs

1. Can KEVEYIS be used for other conditions?
Currently, no. Its approval covers episodic ataxia type 2 and primary periodic paralysis. Pending research could explore broader uses.

2. What are the major hurdles for KEVEYIS's market growth?
Reimbursement issues, limited patient population, and competition from future therapies.

3. How significant is the patent protection for KEVEYIS?
Patent protection extends until at least 2030, limiting generic competition during this period.

4. What is the likelihood of new indications being approved?
Depends on ongoing clinical trials and scientific data. No current regulatory filings suggest imminent expansion.

5. How does KEVEYIS compare to other neuromuscular disease treatments?
It occupies a niche with no direct competitors; most other treatments target broader neuromuscular conditions.

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References

[1] Aquestive Therapeutics. (2022). Annual Financial Report.